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

NCT00561379 | Completed

• 1 other identifier: BRD 04/4-O
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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).

Conditions

Lymphoma, Large-Cell, Diffuse

Keywords

Diffuse Large B Cell Lymphoma; not previously treated

Outcome Measures

Primary Outcomes (1)

• 3 years Event-free survival ( Kaplan Meier method)

Secondary Outcomes (3)

• 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

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: CHOP+RITUXIMAB

2

ACTIVE COMPARATOR

Drug: CEEP-RITUXIMAB

Interventions

CHOP+RITUXIMAB DRUG

CHOP-14- Rituximab x 8 courses

1

CEEP-RITUXIMAB DRUG

High dose chemotherapy with rituximab including autologous stem cell support.

2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, France

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Noel Milpied, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2007
• First Posted: November 21, 2007
• Study Start: April 1, 2005
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 13, 2013

Record last verified: 2013-06

Locations

FR (1)