Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma

Study Overview
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Brief Summary
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Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.

Detailed Description
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This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma . The duration of the treatment period is approximately 25 weeks and patients are followed until Death. From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130). The final analysis was performed in June 2005.

Official Title
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Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).

Conditions
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CD20-Positive Large B-Cell Lymphoma

Intervention / Treatment
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* Drug: ACVBP
* Drug: ACE
* Drug: rituximab
* Procedure: Autologous stem cell transplant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification). Aged from 18 to 59 years, eligible for transplant. Patient not previously treated. Age adjusted International Prognostic Index equal to 2 or 3. Having previously signed a written informed consent. Women of childbearing potential currently practicing an adequate method of contraception. Exclusion Criteria: Any other histological type of lymphoma. Any history of treated or non-treated indolent lymphoma. Central nervous system or meningeal involvement by lymphoma. Contra-indication to any drug contained in the chemotherapy regimens. Poor renal function (creatinin level>150mmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma. Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l, unless related to bone marrow infiltration. Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. Any serious active disease (according to the investigator's decision). HIV, HTLV1 or HBV related disease. Any organ transplantation before inclusion. Pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ACVBP|nan|
|Drug: ACE|nan|
|Drug: rituximab|nan|
|Procedure: Autologous stem cell transplant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To compare response rate to induction treatments (ACVBP vs AC/ACE). |  |  | 
| - To evaluate response rate at the end of treatment. |  |  | 
| - To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing) |  |  | 
| - To evaluate the safety and tolerability of Rituximab |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffuse large B cell lymphoma, Rituximab, Autotransplant