ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1
- Sponsor
- Lymphoma Study Association
- Study ID
- NCT00140595
- Phase
- PHASE3
- Status
- Completed
Conditions
- Diffuse Large-Cell Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 59 Years
- Healthy Volunteers
- Not accepted
Interventions
- rituximab — DRUG
- doxorubicin — DRUG
- cyclophosphamide — DRUG
Study Details
This study is a multicentric randomized trial evaluating the efficacy of the combination ACVBP+rituximab compared to the combination of CHOP+rituximab in patients aged from 18 to 59 years with diffuse large B-cell lymphoma and one factor of the age-adjusted international prognostic index (IPI).
Key Dates
- Start date
- Dec 31, 2003
- Status verified
- Mar 2011
- Primary completion
- Jan 31, 2009
- Completion
- Jan 31, 2009
Study Design
- Enrollment
- 380 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Primary Outcome Measure
Event-free survival (EFS), events defined as death from any cause, relapse for complete responders (CR) and unconfirmed complete responders (CRu), progression during or after treatment, changes of therapy during allocated treatment.