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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00561379

Collaborator

(none)

350

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, Large-Cell, Diffuse	Drug: CHOP+RITUXIMAB Drug: CEEP-RITUXIMAB	N/A

Detailed Description

Diffuse Large B Cell Lymphoma not previously treated

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 1

Drug: CHOP+RITUXIMAB

CHOP-14- Rituximab x 8 courses

Active Comparator: 2

Drug: CEEP-RITUXIMAB

High dose chemotherapy with rituximab including autologous stem cell support.

Outcome Measures

Primary Outcome Measures

3 years Event-free survival ( Kaplan Meier method) []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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