Rituximab Plus Chemotherapy for CD20+ Adult Acute Lymphoblastic Leukemia

Sponsor
Ruijin Hospital
Study ID
NCT01358253
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2)(odd courses).
  • Doxorubicin — DRUG
    50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).
  • Vincristine — DRUG
    Consolidation:1.4 mg/m2 (max 2mg) IV on day 4 and day 11 (odd courses). Maintenance:1.4mg/m2(max 2mg) IV monthly from 1st to 12th month.
  • Dexamethasone — DRUG
    40mg IV or by mouth (P.O.) daily days 1-4 and days 11-14(odd courses)
  • Cytarabine — DRUG
    2g/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).
  • Methotrexate — DRUG
    Consolidation:1000 mg/m2 IV over 24 hours on day 1 (even courses). Maintenance:25mg/m2 weekly for 24 months.
  • Rituximab — DRUG
    Consolidation:375 mg/m2 IV day 1 for the odd courses of therapy (total 4 times). Maintenance:375 mg/m2 IV in 6th month and 12th month.
  • 6-Mercaptopurine — DRUG
    Maintenance:60mg/m2 daily for 24 months.
  • Prednisone — DRUG
    Maintenance:40mg/m2 from days 1-7 monthly from 1st to 12th month.
  • L-asparaginase — DRUG
    Maintenance:6000IU/m2 IV on days 1,3,5 of the 3rd and 9th month.

Study Details

The main purpose of this study is to evaluate the safety and efficacy of Rituximab combined with chemotherapy in CD20+ adult acute lymphoblastic leukemia.

Key Dates

Start date
Dec 31, 2010
Status verified
May 2011
Primary completion
Dec 31, 2012
Completion
Dec 31, 2012

Study Design

Enrollment
100 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: HyperCVAD
    Consolidation: HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Maintenance: 6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9.
  • Experimental: R-HyperCVAD
    Consolidation: R-HyperCVAD(odd courses) alternated with high-dose methotrexate + cytarabine (even courses) every 21 days or later to allow for myelosuppression recovery, for total of 8 courses. Maintenance: 6-Mercaptopurine+Methotrexate for 24 months. Vincristine+Prednisone for the first 12 months. L-asparaginase in month 3 and 9. Rituximab in month 6 and 12.

Primary Outcome Measure

CR duration [ Time Frame: After two 21-day courses ]

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