R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma

Sponsor
Lymphoma Study Association
Study ID
NCT00135499
Phase
PHASE3
Status
Terminated

Conditions

  • Lymphoma, Large-Cell, Diffuse

Eligibility Criteria

Sex
ALL
Age
60 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    375 mg/m², D1, 4 cycles
  • Doxorubicin — DRUG
    75 mg/m², D1, 4 cycles
  • Cyclophosphamide — DRUG
    1200 mg/m², D1, 4 cycles
  • Vindesine — DRUG
    2 mg/m², D1, D5, 4 cycles
  • Bleomycin — DRUG
    10 mg, D1, D5, 4 cycles
  • Prednisone — DRUG
    60 mg, D1-D5, 4 cycles
  • Prednisone — DRUG
    40 mg, D1-D5, 4 cycles
  • Doxorubicin — DRUG
    50 mg/m², D1, 4 cycles
  • Cyclophosphamide — DRUG
    750 mg/m², D1, 4 cycles
  • Vincristine — DRUG
    1.4 mg/m², D1, 4 cycles

Study Details

The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) plus rituximab in patients aged from 60 to 65 years with non-previously treated diffuse large B-cell lymphoma as measured by the event-free survival. The goal is to obtain a 10% increase of event-free survival at 3 years.

Key Dates

Start date
Oct 16, 2001
Status verified
Aug 2018
Primary completion
Apr 27, 2010
Completion
Apr 27, 2010

Study Design

Enrollment
138 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: R-ACVBP
    Rituximab, Doxorubicin, Cyclophosphamide, Vindesine, Bleomycin, Prednisone
  • Active Comparator: R-CHOP
    Rituximab, Doxorubicin, Cyclophosphamide, Vincristine, Prednisone

Primary Outcome Measure

event free survival [ Time Frame: 8 years (end of study) ]