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

NCT ID: NCT00561379

Last Updated: 2013-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2013-05-31

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

Conditions

Lymphoma, Large-Cell, Diffuse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

CHOP+RITUXIMAB

Intervention Type: DRUG

CHOP-14- Rituximab x 8 courses

2

Group Type: ACTIVE_COMPARATOR

CEEP-RITUXIMAB

Intervention Type: DRUG

High dose chemotherapy with rituximab including autologous stem cell support.

Interventions

CHOP+RITUXIMAB

CHOP-14- Rituximab x 8 courses

Intervention Type: DRUG

CEEP-RITUXIMAB

High dose chemotherapy with rituximab including autologous stem cell support.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Noel Milpied, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Nantes University Hospital

Nantes, , France

Countries

France

Other Identifiers

BRD 04/4-O

Identifier Type: -

Identifier Source: org_study_id