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NCT00392990 · FLOW

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Doxorubicin Hydrochloride Liposome and Rituximab With Combination Chemotherapy in Treating Patients With Newly Diagnosed Burkitt's Lymphoma or Burkitt-Like Lymphoma · Source last updated 2019-10-15

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

groups
  1. description
    Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A). Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
    id
    FG000
    title
    Low Risk - Treatment With 3 Cycles of R-CODOX-M
  2. description
    Patients are stratified between high risk and low risk disease status. High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated. Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
    id
    FG001
    title
    High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Treatment on Study
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        5
      comment
      All patients that receive one dose of study drug go into the follow-up phase.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        5
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Follow up for 2 Years
pre Assignment Details
Patients were stratified as either high-risk or low-risk. Low Risk= patients with normal Lactic acid dehydrogenase (LDH) level, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, Ann Arbor stage as I or II and no tumor mass over 10 cm in greatest diameter. High Risk = All other patients
recruitment Details
The study opened for accrual on October 4, 2006 with the first patient enrolling and starting treatment on February 6, 2007 and an accrual goal of up to 25 patients. The study was closed permanently on April 26, 2011 to further accrual with 25 patients enrolled on the study.
Complete source fields
groups
  1. description
    Patients are stratified between high risk and low risk disease status. Low risk patients receive 3 cycles of rituximab (500 mg/m2) R-CODOX-M chemotherapy IV over 2-4 hours with intrathecal chemotherapy (Regimen A). Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
    id
    FG000
    title
    Low Risk - Treatment With 3 Cycles of R-CODOX-M
  2. description
    Patients are stratified between high risk and low risk disease status. High risk patients receive 1 cycle of R-CODOX-M chemotherapy IV followed by R-IVAC chemotherapy over 30 minutes(Regimen B); regimens A and B are then repeated. Regimen A: Cyclophosphamide (800 mg/m2 IV over 1 hour)+ vincristine (1.5 mg/m2 IV PUSH)+ doxorubicin (40 mg/m2 IV)+ high-dose methotrexate (2,700 mg/m2 IV over 23 hours)+ rituximab (500 mg/m2 IV)(R-CODOX-M) regimen Regimen B: Rituximab (500 mg/m2 IV once)+ Ifosfamide (1500 mg/m2 IV daily over 3 hours)+ Etoposide (60 mg/m2 IV daily over 1 hour), and Cytarabine (2 grams/m2 IV over 3 hours for 4 doses)
    id
    FG001
    title
    High Risk - Treatment With Alternating R-CODOX-M/R-IVAC Cycles
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      Adverse Event
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        5
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        17
      2. group Id
        FG001
        num Subjects
        4
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Treatment on Study
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        20
      2. group Id
        FG001
        num Subjects
        5
      comment
      All patients that receive one dose of study drug go into the follow-up phase.
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        5
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        4
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Follow up for 2 Years
pre Assignment Details
Patients were stratified as either high-risk or low-risk. Low Risk= patients with normal Lactic acid dehydrogenase (LDH) level, Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, Ann Arbor stage as I or II and no tumor mass over 10 cm in greatest diameter. High Risk = All other patients
recruitment Details
The study opened for accrual on October 4, 2006 with the first patient enrolling and starting treatment on February 6, 2007 and an accrual goal of up to 25 patients. The study was closed permanently on April 26, 2011 to further accrual with 25 patients enrolled on the study.

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Preserved source evidence · Not medical advice