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
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 April 17, 2014