High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma

August 25, 2009 updated by: Nantes University Hospital

Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.

A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 2

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, 44000
        • 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 to 60 y.o
  • Aggressive Large B-Cell Lymphoma (CD20+)
  • Ann Arbor stage III, IV
  • IH or high adjusted IPI
  • signed inform consent

Exclusion Criteria:

  • Age < 18 ou > 60 y.o
  • other type of lymphoma
  • serology VIH +
  • other neoplasms apart from basal cell carcinoma or situ carcinoma

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: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: HDT combined with rituximab before ASCT
The study treatment consisted on 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.
Drug: Rituximab
Rituximab infusion on day 1 dose: 375mg/m²
Other Names:
  • Mabthera®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
CR rate after 3 high dose chemotherapy courses
Time Frame: safety/efficacy of chemotherapy treatment
safety/efficacy of chemotherapy treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
CR and PR rate at the end of the study treatment
Time Frame: safety/efficacy of treatment30 days after the end of post ASCT aplasia
safety/efficacy of treatment30 days after the end of post ASCT aplasia
PFS,EFS and OS
Time Frame: safety/efficacy of study treatment
safety/efficacy of study treatment
Tolerance of Rituximab combined with chemotherapy
Time Frame: safety/efficacy of immunotherapy combined with chemotherapy treatment
safety/efficacy of immunotherapy combined with chemotherapy treatment

Collaborators and Investigators

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

Sponsor

Nantes University Hospital

Collaborators

Hoffmann-La Roche
French Innovative Leukemia Organisation

Investigators

  • Principal Investigator: Noel MILPIED, PD MS, CHU NANTES/GOELAMS

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, 2002

Primary Completion (ACTUAL)

May 1, 2003

Study Completion (ACTUAL)

June 1, 2009

Study Registration Dates

First Submitted

August 24, 2009

First Submitted That Met QC Criteria

August 24, 2009

First Posted (ESTIMATE)

August 25, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2009

Last Update Submitted That Met QC Criteria

August 25, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOELAMS 074

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.

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