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NCT01190930 · FLOW

Participant flow

Risk-Adapted Chemotherapy in Treating Younger Patients With Newly Diagnosed Standard-Risk Acute Lymphoblastic Leukemia or Localized B-Lineage Lymphoblastic Lymphoma · Source last updated 2026-05-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups
  1. description
    All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate on days 8 and 29. Patients with DS also receive leucovorin calcium every 12 hours on days 10-11 and 21-32. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 \[\> 25% lymphoblasts\] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study.
    id
    FG000
    title
    B-ALL
  2. description
    Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
    id
    FG001
    title
    B-LLy
  3. description
    Consolidation (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34
    id
    FG002
    title
    B-ALL Average Risk
  4. description
    Consolidation (4 w): vincristine (VIN) d1; MP d1-28; IT methotrexate (MTX) d1/8/15; leucovorin (LV) d3-4/10-11/17-18 Interim maintenance I (8 wks): VIN \& IV MTX d1/11/21/31/41; IT MTX d31; LV d36-34 Delayed-intensification (8 wks): Patients receive dexamethasone (DEX) d1-7/15-21; VIN \& doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/33-39; IT MTX d1/29; and LV d3-4/31-32 Interim maintenance II (8 wks): VIN \& IV MTX d1/11/21/31/41; IT MTX d1/31; and LV d3-4/33-34 Maintenance: VIN d1; DEX d1-5; PO MTX wkly d8-78; MP d1-84; and IT MTX d1. Courses repeat every 12 wks for 2 years (timed from the start of interim maintenance I therapy).
    id
    FG003
    title
    Standard Risk With Down Syndrome
  5. description
    Consolidation (19 w): vincristine (VIN) day(d) 15/22/78/85; IV/IT methotrexate (MTX) d8/29/50/71/92/113; leucovorin (LV) d9-10/30-31/51-52/72-73/93-94/114-115; dexamethasone (DEX) d15-21/78-84; mercaptopurine (MP) d 1-133. Maint.: VIN d1/8; DEX d1-7; MTX\* PO wkly d1-106; MP d 1-112. Repeat every 16 w until 2.5 yrs from dx. IT MTX d1/85 (course 1\&4), d 57 (course 2\&5), d29 (course 3\&6). Course 7: VIN d1/8; DEX d 1-7; MTX PO wkly d8-64; and MP d1-70. \*Patients do not receive MTX PO on d w/ IT MTX.
    id
    FG004
    title
    B-ALL Low Risk Arm I (LR-M)
  6. description
    Consolidation (4 w): VIN d1; MP d1-28; IT MTX d1/8/15 Interim Maint. I (8 w): VIN \& IV MTX d1/11/21/31/41; IT MTX d31 Delayed-intensification (8 w): DEX d1-7/15-21; VIN \& doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/36-39; IT MTX d1/29 Interim Maint. II (8 w): VIN \& IV MTX d1/11/21/31/41; IT MTX d1/31 Maint.: VIN d1; DEX d1-5; MTX PO wkly d22-78; MP d 1-84; IT MTX d1. Rpt every 12 w for 2 yrs:girls, 3 yrs:boys from start IM1
    id
    FG005
    title
    B-ALL Low Risk Arm II (LR-C)
  7. description
    Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1+P8:W8-84; and IT MTX d 1
    id
    FG006
    title
    B-ALL Average Risk-Arm A
  8. description
    Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1
    id
    FG007
    title
    B-ALL Average Risk-Arm B
  9. description
    Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1
    id
    FG008
    title
    B-ALL Average Risk-Arm C
  10. description
    Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
    id
    FG009
    title
    B-ALL Average Risk-Arm D
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        125
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        235
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Refusal
    7. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Inevaluable
    8. reasons
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      BM MRD >= 0.01% on Day 29 of Induction
    9. reasons
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      High Risk Downs
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Enrollment onto another COG Protocol
    11. reasons
      1. group Id
        FG000
        num Subjects
        1847
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Average Risk
    12. reasons
      1. group Id
        FG000
        num Subjects
        1227
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      High Risk
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        9298
      2. group Id
        FG001
        num Subjects
        52
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3949
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5349
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Induction
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        694
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Refusal
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Inevaluable
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      CR failure at the end of consolidation
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Progressive disease
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Relapse
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        3122
      4. group Id
        FG003
        num Subjects
        224
      5. group Id
        FG004
        num Subjects
        301
      6. group Id
        FG005
        num Subjects
        302
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        2364
      4. group Id
        FG003
        num Subjects
        207
      5. group Id
        FG004
        num Subjects
        296
      6. group Id
        FG005
        num Subjects
        296
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        758
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Post Induction Pre-Maintenance
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        10
      10. group Id
        FG009
        num Subjects
        17
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        1
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        17
      9. group Id
        FG008
        num Subjects
        13
      10. group Id
        FG009
        num Subjects
        6
      type
      Refusal
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      second malignant neoplasm
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Inevaluable
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Enrollment onto another COG Protocol
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        13
      9. group Id
        FG008
        num Subjects
        11
      10. group Id
        FG009
        num Subjects
        11
      type
      Relapse
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        29
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Still on therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        207
      5. group Id
        FG004
        num Subjects
        296
      6. group Id
        FG005
        num Subjects
        296
      7. group Id
        FG006
        num Subjects
        600
      8. group Id
        FG007
        num Subjects
        586
      9. group Id
        FG008
        num Subjects
        586
      10. group Id
        FG009
        num Subjects
        592
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        167
      5. group Id
        FG004
        num Subjects
        287
      6. group Id
        FG005
        num Subjects
        284
      7. group Id
        FG006
        num Subjects
        574
      8. group Id
        FG007
        num Subjects
        540
      9. group Id
        FG008
        num Subjects
        540
      10. group Id
        FG009
        num Subjects
        555
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        40
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        26
      8. group Id
        FG007
        num Subjects
        46
      9. group Id
        FG008
        num Subjects
        46
      10. group Id
        FG009
        num Subjects
        37
      type
      NOT COMPLETED
    title
    Maintenance
pre Assignment Details
Patients were stratified between 2 disease groups (B-ALL and B-LLY) for Induction and then risk assigned treatment based upon the patient's response.
recruitment Details
Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)
Complete source fields
groups
  1. description
    All patients receive induction therapy comprising intrathecal (IT) cytarabine on day 1; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) or IV twice daily (BID) on days 1-28; pegaspargase IV over 1-2 hours on day 4; and IT methotrexate on days 8 and 29. Patients with DS also receive leucovorin calcium every 12 hours on days 10-11 and 21-32. Patients with Philadelphia chromosome-positive disease are eligible to transfer to COG-AALL0622 by day 15 of induction therapy and patients with high-risk (HR) or very high-risk (VHR) disease are eligible to transfer to a COG HR or VHR trial at the end of induction therapy. Patients with standard-risk disease with Down syndrome (DS) who have bone marrow minimal residual disease 0.01% are eligible to transfer to the DS stratum of the HR trial. Patients with induction failure (defined as M3 \[\> 25% lymphoblasts\] on day 29) may be eligible for the COG VHR-acute lymphoblastic leukemia study.
    id
    FG000
    title
    B-ALL
  2. description
    Induction: same trt as B-ALL; Consolidation (4 wks): vincristine sulfate day 1; mercaptopurine days 1-28; IT methotrexate (MTX) days 1/8/15; leucovorin calcium days 3-4,10-11,17-18 Interim maintenance I (8 wks): vincristine sulfate and MTX 2-15 min days 1/11/21/31/41; IT MTX day 31; leucovorin calcium days 33-34 Delayed-intensification (8 wks): dexamethasone days 1-7 and 15-21; vincristine sulfate and doxorubicin hydrochloride on days 1/8/15; pegaspargase 1-2 hrs day 4; cyclophosphamide day 29; thioguanine days 29-42; cytarabine 29-32, 33-39; IT MTX days 1/29; and leucovorin calcium days 3-4, 31-32 Interim maintenance II (8 wks): vincristine sulfate and MTX days 1/11/21/31/41; IT MTX days 1/31; and leucovorin calcium days 3-4, 33/34 Maintenance: vincristine sulfate day 1; dexamethasone days 1-5; MTX weekly days 8-78; mercaptopurine days 1-84; and IT MTX day 1. Courses repeat every 4 wks for 2 yrs (from the start of IMI therapy).
    id
    FG001
    title
    B-LLy
  3. description
    Consolidation (4 wks): vincristine (VIN) day (d) 1; mercaptopurine (MP) d 1-28; IT MTX d 1/8/15; leucovorin (LV) d 3-4/10-11/17-18 Int. maint. I (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 31; LV d 33-34 Delayed-intensification (8 wks): dexamethasone (DEX) d 1-7/15-21; VIN and doxorubicin d 1/8/15; pegaspargase d 4; cyclophosphamide d 29; thioguanine d 29-42; cytarabine d 29-32/33-39; IT MTX d 1/29; LV d 3-4/31-32 Int. maint. II (8 wks): VIN and MTX d 1/11/21/31/41; IT MTX d 1/31; LV d 3-4/33-34
    id
    FG002
    title
    B-ALL Average Risk
  4. description
    Consolidation (4 w): vincristine (VIN) d1; MP d1-28; IT methotrexate (MTX) d1/8/15; leucovorin (LV) d3-4/10-11/17-18 Interim maintenance I (8 wks): VIN \& IV MTX d1/11/21/31/41; IT MTX d31; LV d36-34 Delayed-intensification (8 wks): Patients receive dexamethasone (DEX) d1-7/15-21; VIN \& doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/33-39; IT MTX d1/29; and LV d3-4/31-32 Interim maintenance II (8 wks): VIN \& IV MTX d1/11/21/31/41; IT MTX d1/31; and LV d3-4/33-34 Maintenance: VIN d1; DEX d1-5; PO MTX wkly d8-78; MP d1-84; and IT MTX d1. Courses repeat every 12 wks for 2 years (timed from the start of interim maintenance I therapy).
    id
    FG003
    title
    Standard Risk With Down Syndrome
  5. description
    Consolidation (19 w): vincristine (VIN) day(d) 15/22/78/85; IV/IT methotrexate (MTX) d8/29/50/71/92/113; leucovorin (LV) d9-10/30-31/51-52/72-73/93-94/114-115; dexamethasone (DEX) d15-21/78-84; mercaptopurine (MP) d 1-133. Maint.: VIN d1/8; DEX d1-7; MTX\* PO wkly d1-106; MP d 1-112. Repeat every 16 w until 2.5 yrs from dx. IT MTX d1/85 (course 1\&4), d 57 (course 2\&5), d29 (course 3\&6). Course 7: VIN d1/8; DEX d 1-7; MTX PO wkly d8-64; and MP d1-70. \*Patients do not receive MTX PO on d w/ IT MTX.
    id
    FG004
    title
    B-ALL Low Risk Arm I (LR-M)
  6. description
    Consolidation (4 w): VIN d1; MP d1-28; IT MTX d1/8/15 Interim Maint. I (8 w): VIN \& IV MTX d1/11/21/31/41; IT MTX d31 Delayed-intensification (8 w): DEX d1-7/15-21; VIN \& doxorubicin d1/8/15; pegaspargase d4; cyclophosphamide d29; thioguanine d 29-42; cytarabine d29-32/36-39; IT MTX d1/29 Interim Maint. II (8 w): VIN \& IV MTX d1/11/21/31/41; IT MTX d1/31 Maint.: VIN d1; DEX d1-5; MTX PO wkly d22-78; MP d 1-84; IT MTX d1. Rpt every 12 w for 2 yrs:girls, 3 yrs:boys from start IM1
    id
    FG005
    title
    B-ALL Low Risk Arm II (LR-C)
  7. description
    Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; MTX weekly d 8-78; MP d 1+P8:W8-84; and IT MTX d 1
    id
    FG006
    title
    B-ALL Average Risk-Arm A
  8. description
    Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1/29/57; DEX d 1-5/29-33/57-61; high-dose (HD) MTX weekly d 8-78; MP d 1-84; and IT MTX d 1
    id
    FG007
    title
    B-ALL Average Risk-Arm B
  9. description
    Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; MTX weekly d 8-78; MP d 1-84; IT MTX d 1
    id
    FG008
    title
    B-ALL Average Risk-Arm C
  10. description
    Maintenance: repeat every 12 wks for 2 yrs (girls), 3 yrs (boys) from start IM1: VIN d 1; DEX d 1-5; HD MTX weekly d 8-78; MP d 1-84; IT MTX d 1
    id
    FG009
    title
    B-ALL Average Risk-Arm D
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        34
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        125
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        9
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        235
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Refusal
    7. reasons
      1. group Id
        FG000
        num Subjects
        23
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Inevaluable
    8. reasons
      1. group Id
        FG000
        num Subjects
        61
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      BM MRD >= 0.01% on Day 29 of Induction
    9. reasons
      1. group Id
        FG000
        num Subjects
        80
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      High Risk Downs
    10. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Enrollment onto another COG Protocol
    11. reasons
      1. group Id
        FG000
        num Subjects
        1847
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Average Risk
    12. reasons
      1. group Id
        FG000
        num Subjects
        1227
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      High Risk
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        9298
      2. group Id
        FG001
        num Subjects
        52
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3949
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        5349
      2. group Id
        FG001
        num Subjects
        9
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Induction
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        8
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        35
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Physician Decision
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Withdrawal by Subject
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        694
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Refusal
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        6
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Inevaluable
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      CR failure at the end of consolidation
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Progressive disease
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Relapse
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        43
      3. group Id
        FG002
        num Subjects
        3122
      4. group Id
        FG003
        num Subjects
        224
      5. group Id
        FG004
        num Subjects
        301
      6. group Id
        FG005
        num Subjects
        302
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        2364
      4. group Id
        FG003
        num Subjects
        207
      5. group Id
        FG004
        num Subjects
        296
      6. group Id
        FG005
        num Subjects
        296
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        758
      4. group Id
        FG003
        num Subjects
        17
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Post Induction Pre-Maintenance
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        3
      10. group Id
        FG009
        num Subjects
        0
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        2
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        2
      type
      Death
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Lost to Follow-up
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        5
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        8
      8. group Id
        FG007
        num Subjects
        8
      9. group Id
        FG008
        num Subjects
        10
      10. group Id
        FG009
        num Subjects
        17
      type
      Physician Decision
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        2
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        4
      10. group Id
        FG009
        num Subjects
        1
      type
      Withdrawal by Subject
    6. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        4
      7. group Id
        FG006
        num Subjects
        5
      8. group Id
        FG007
        num Subjects
        17
      9. group Id
        FG008
        num Subjects
        13
      10. group Id
        FG009
        num Subjects
        6
      type
      Refusal
    7. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      second malignant neoplasm
    8. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        1
      8. group Id
        FG007
        num Subjects
        1
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Inevaluable
    9. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        1
      10. group Id
        FG009
        num Subjects
        0
      type
      Enrollment onto another COG Protocol
    10. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        6
      8. group Id
        FG007
        num Subjects
        13
      9. group Id
        FG008
        num Subjects
        11
      10. group Id
        FG009
        num Subjects
        11
      type
      Relapse
    11. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        8
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        29
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      type
      Still on therapy
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        37
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        207
      5. group Id
        FG004
        num Subjects
        296
      6. group Id
        FG005
        num Subjects
        296
      7. group Id
        FG006
        num Subjects
        600
      8. group Id
        FG007
        num Subjects
        586
      9. group Id
        FG008
        num Subjects
        586
      10. group Id
        FG009
        num Subjects
        592
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        27
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        167
      5. group Id
        FG004
        num Subjects
        287
      6. group Id
        FG005
        num Subjects
        284
      7. group Id
        FG006
        num Subjects
        574
      8. group Id
        FG007
        num Subjects
        540
      9. group Id
        FG008
        num Subjects
        540
      10. group Id
        FG009
        num Subjects
        555
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        10
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        40
      5. group Id
        FG004
        num Subjects
        9
      6. group Id
        FG005
        num Subjects
        12
      7. group Id
        FG006
        num Subjects
        26
      8. group Id
        FG007
        num Subjects
        46
      9. group Id
        FG008
        num Subjects
        46
      10. group Id
        FG009
        num Subjects
        37
      type
      NOT COMPLETED
    title
    Maintenance
pre Assignment Details
Patients were stratified between 2 disease groups (B-ALL and B-LLY) for Induction and then risk assigned treatment based upon the patient's response.
recruitment Details
Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-lineage Lymphoblastic Lymphoma (B-LLy)

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Preserved source evidence · Not medical advice