Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma

This study has been terminated.
Sponsor:
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00169169
First received: September 13, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted
  Purpose

Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.


Condition Intervention Phase
CD20-Positive Large B-Cell Lymphoma
Drug: ACVBP
Drug: ACE
Drug: rituximab
Procedure: Autologous stem cell transplant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomised Phase 3 Study of Rituximab in High-Risk Patients With Diffuse Large B-Cell Lymphoma Who Received a First-Line Consolidative Chemotherapy With Autologous Stem Cell Transplant (ASCT).

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures:
  • - To compare event-free survival of patients randomized to receive Rituximab or no further therapy after HDT

Secondary Outcome Measures:
  • - To compare response rate to induction treatments (ACVBP vs AC/ACE).
  • - To evaluate response rate at the end of treatment.
  • - To compare overall survival (ACVBP vs AC/ACE; Rituximab / nothing)
  • - To evaluate the safety and tolerability of Rituximab

Estimated Enrollment: 430
Study Start Date: October 1999
Estimated Study Completion Date: August 2005
Detailed Description:

This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IPI 2 or 3 ) Diffuse Large B-Cell Lymphoma .

The duration of the treatment period is approximately 25 weeks and patients are followed until Death.

From 10/99 to 05/03, 476 patients were enrolled. 235 patients were assigned to receive ACE and 241 to ACVBP. Among the 331 patients, in Complete response (CR+CRu) after induction, who received HDC, 269 were randomized (R2) after hematological recovery to receive either rituximab (n=139) or nothing (n=130).

The final analysis was performed in June 2005.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification).
  • Aged from 18 to 59 years, eligible for transplant.
  • Patient not previously treated.
  • Age adjusted International Prognostic Index equal to 2 or 3.
  • Having previously signed a written informed consent.
  • Women of childbearing potential currently practicing an adequate method of contraception.

Exclusion Criteria:

  • Any other histological type of lymphoma.
  • Any history of treated or non-treated indolent lymphoma.
  • Central nervous system or meningeal involvement by lymphoma.
  • Contra-indication to any drug contained in the chemotherapy regimens.
  • Poor renal function (creatinin level>150mmol/l), poor hepatic function (total bilirubin level>30mmol/l, transaminases>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
  • Poor bone marrow reserve as defined by neutrophils < 1.5 G/l or platelets < 100 G/l, unless related to bone marrow infiltration.
  • Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
  • Any serious active disease (according to the investigator’s decision).
  • HIV, HTLV1 or HBV related disease.
  • Any organ transplantation before inclusion.
  • Pregnant women.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00169169

Locations
France
Hôpital Henri Mondor
Créteil, France
Hôpital Saint Louis
Paris, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France
Centre Henri Becquerel
Rouen, France
CHRU de Nancy Brabois
Vandoeuvre-les-Nancy, France
Sponsors and Collaborators
Lymphoma Study Association
Investigators
Study Chair: Corinne Haioun Hôpital Henri Mondor, Créteil, France
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00169169     History of Changes
Other Study ID Numbers: LNH-98.3
Study First Received: September 13, 2005
Last Updated: September 13, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lymphoma Study Association:
Diffuse large B cell lymphoma
Rituximab
Autotransplant

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
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