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

Not Applicable

Completed

• Conditions: Lymphoma, Large-Cell, Diffuse
• Interventions: Drug: CHOP+RITUXIMAB; Drug: CEEP-RITUXIMAB

• Registration Number: NCT00561379
• Lead Sponsor: Nantes University Hospital

Brief Summary

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

Diffuse Large B Cell Lymphoma not previously treated

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-21
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-12
• Last Update Posted: 2013-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CHOP+RITUXIMAB	-
2	CEEP-RITUXIMAB	-

Primary Outcome Measures

Name	Time	Method
3 years Event-free survival ( Kaplan Meier method)

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France