Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab
- Sponsor
- Nantes University Hospital
- Study ID
- NCT00561379
- Status
- Completed
Conditions
- Lymphoma, Large-Cell, Diffuse
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- CHOP+RITUXIMAB — DRUGCHOP-14- Rituximab x 8 courses
- CEEP-RITUXIMAB — DRUGHigh dose chemotherapy with rituximab including autologous stem cell support.
Study Details
The aim of the protocol is to compare the outcome of patients with DLBCL stage II bulky, III or IV with 1 to 3 adverse prognostic factors according to the International prognostic index. Patients with eligibility criteria and who gave informed consent will be randomised between CHOP-14- Rituximab x 8 courses and High dose chemotherapy with rituximab including autologous stem cell support. The aim of the study is to compare the Event free survival between the two arms and to gain insight into the prognostic significance of several biological markers gathered at the time of diagnosis/randomisation ( i.e. Fcgamma R III A genotyping, DNA profile and BCL é expression).
Key Dates
- Start date
- Apr 30, 2005
- Status verified
- Jun 2013
- Primary completion
- May 31, 2013
- Completion
- May 31, 2013
Study Design
- Enrollment
- 350 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: 1
- Active Comparator: 2
Primary Outcome Measure
3 years Event-free survival ( Kaplan Meier method)