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

June 12, 2013 updated by: Nantes University Hospital

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diffuse Large B Cell Lymphoma not previously treated

Study Type

Interventional

Enrollment (Anticipated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • Nantes University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
3 years Event-free survival ( Kaplan Meier method)

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Noel Milpied, MD, CHU Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 20, 2007

First Posted (Estimate)

November 21, 2007

Study Record Updates

Last Update Posted (Estimate)

June 13, 2013

Last Update Submitted That Met QC Criteria

June 12, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD 04/4-O

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe