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

This study has been completed.
Sponsor:
Collaborators:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Hoffmann-La Roche
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00965289
First received: August 24, 2009
Last updated: August 25, 2009
Last verified: August 2009
  Purpose

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.


Condition Intervention Phase
B-Cell Lymphoma
Drug: Rituximab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • CR rate after 3 high dose chemotherapy courses [ Time Frame: safety/efficacy of chemotherapy treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • PFS,EFS and OS [ Time Frame: safety/efficacy of study treatment ] [ Designated as safety issue: Yes ]
  • Tolerance of Rituximab combined with chemotherapy [ Time Frame: safety/efficacy of immunotherapy combined with chemotherapy treatment ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: April 2002
Study Completion Date: June 2009
Primary Completion Date: May 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mabthera®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00965289

Locations
France
University Hospital
Nantes, France, 44000
Sponsors and Collaborators
Nantes University Hospital
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Hoffmann-La Roche
Investigators
Principal Investigator: Noel MILPIED, PD MS CHU NANTES/GOELAMS
  More Information

Additional Information:
No publications provided

Responsible Party: Pr Noel MILPIED, NANTES UNIVERSITY HOSPITAL /GOELAMS
ClinicalTrials.gov Identifier: NCT00965289     History of Changes
Other Study ID Numbers: GOELAMS 074
Study First Received: August 24, 2009
Last Updated: August 25, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Aggressive large B-cell lymphoma (DLBCL)
Intensive chemotherapy
Rituximab
ASCT

Additional relevant MeSH terms:
Aggression
Lymphoma
Lymphoma, B-Cell
Behavioral Symptoms
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 29, 2014