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NCT01190930 · OUTCOME

DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens

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.

Measure
NUMBER
Unit
percent probability
Interval / dispersion
95% Confidence Interval
Time frame
5.1 years

What was measured

DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.

Groups in this outcome

B-ALL Low Risk Arm I (LR-M)

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.

B-ALL Low Risk Arm II (LR-C)

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
B-ALL Low Risk Arm I (LR-M)301
B-ALL Low Risk Arm II (LR-C)302

Reported measurements

Source class 1
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
B-ALL Low Risk Arm I (LR-M)98.75Not reported97.14100.00Not reported
B-ALL Low Risk Arm II (LR-C)98.50Not reported96.75100.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        97.14
        upper Limit
        100.00
        value
        98.75
      2. group Id
        OG001
        lower Limit
        96.75
        upper Limit
        100.00
        value
        98.50
denoms
  1. counts
    1. group Id
      OG000
      value
      301
    2. group Id
      OG001
      value
      302
    units
    Participants
description
DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated.
dispersion Type
95% Confidence Interval
groups
  1. 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
    OG000
    title
    B-ALL Low Risk Arm I (LR-M)
  2. 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
    OG001
    title
    B-ALL Low Risk Arm II (LR-C)
param Type
NUMBER
reporting Status
POSTED
time Frame
5.1 years
title
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
type
PRIMARY
unit Of Measure
percent probability

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Preserved source evidence · Not medical advice