Diffuse Large B Cell Lymphoma of the Adult: Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14-Rituximab

Study Overview
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Brief Summary
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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).

Detailed Description
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Diffuse Large B Cell Lymphoma not previously treated

Official Title
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Frontline Therapy of Diffuse Large B Cell Lymphoma of the Adult ( 18 to 60 Years Old): Randomization Between High Dose Chemotherapy With Rituximab and CHOP 14 -Rituximab. Multicentric Randomized Prospective Trial.

Conditions
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Lymphoma, Large-Cell, Diffuse

Intervention / Treatment
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* Drug: CHOP+RITUXIMAB
* Drug: CEEP-RITUXIMAB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 et ≤ 60 and male and female Diffuse large B cell lymphoma according to WHO classification phénotype B CD 20 + Stage I et II tumor bulk > 7 cm and stage III et IV Ann Arbor. Non previously treated HIV négative Signed informed consent Exclusion Criteria: Age < 18 and/or > 60 ans NHL not DLBCL Lymphoblastic Lymphoma Burkitt's Lymphoma Low grade Lymphoma transformed Primary CNS Lymphomal Post- transplantation Lymphoma CD20 negative Ann Arbor stage I or II without tumor bulk > 7 cm Previous treatment HIV positive Contre-indication to Rituximab use according to SmPC Contre-indication to high dose chemotherapy due to organ failure not related to the lymphoma Cancer or history of cancer with the exception of in situ cancer of the cervix or non-invasive skin epithelioma Patient not able to understand the proposed treatments Refusal to sign the informed consent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: CHOP+RITUXIMAB<br>* CHOP-14- Rituximab x 8 courses<br>|
| Active Comparator: 2<br> | Drug: CEEP-RITUXIMAB<br>* High dose chemotherapy with rituximab including autologous stem cell support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 years Event-free survival ( Kaplan Meier method) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 years overall survival |  |  | 
| Prognostic impact of: Level of expression of protéine bcl2 protein in tumor cells; FCGR3A genotype; génomic profile (DNA microarray)on response, survival, and Event-Free-Survival |  |  | 
| Cost |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diffuse Large B Cell Lymphoma, not previously treated