Randomized Study for Patients With Follicular Lymphoma Needing Treatment

This study has been completed.
Sponsor:
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00140569
First received: August 31, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  Purpose

2 parallel studies.

  • For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
  • For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months

Condition Intervention Phase
Follicular Lymphoma
Procedure: CHVP + interferon
Drug: fludarabine
Procedure: CHOP + TBI and autotransplant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Study for Patients With Follicular Lymphoma Needing Treatment

Resource links provided by NLM:


Further study details as provided by Lymphoma Study Association:

Primary Outcome Measures:
  • Progression-free survival

Secondary Outcome Measures:
  • Overall survival
  • Toxicity
  • Response rates

Estimated Enrollment: 400
Study Start Date: January 1994
Estimated Study Completion Date: January 2004
Detailed Description:

2 parallel studies.

  • For young patients (18-60 years): randomization between CHVP + interferon for 18 months and 4 CHOP followed by autotransplant after TBI
  • For elderly patients (>60 years): randomization between CHVP + interferon for 18 months and fludarabine 5 days every months for 6 months
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • study 1 (young patients): being less than 61 years old with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)
  • study 2 (elderly patients): being older than 60 years with a follicular lymphoma and needing to be treated because of high LDH level, high beta-2 microglobulin level, poor performance status, or large tumoral mass (lymph node >7 cm, symptomatic splenomegaly, pleura effusion, or sign of compression by the tumor mass)

Exclusion Criteria:

  • contra-indication to anthracycline or interferon
  • transformation into large cell lymphoma
  • previous treatment
  • localized stage without criteria of large tumor mass
  • patients HIV+
  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: NCT00140569

Locations
Belgium
Groupe d'atude des lymphome de l'adulte
Yvoir, Belgium
France
Hôpital Henri Mondor
Créteil, France, 94010
Centre Léon Bérard
Lyon, France, 69008
Hôpital Saint Louis
Paris, France, 75010
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France, 69495
Centre Hospitalier Robert Debré
Reims, France, 51092
Centre Henri Becquerel
Rouen, France, 76038
Institut Gustave Roussy
Villejuif, France
Sponsors and Collaborators
Lymphoma Study Association
Investigators
Study Chair: Bertrand Coiffier, MD Hospices Civils de Lyon
Principal Investigator: Catherine Sebban, MD Centre Léon Bérard
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00140569     History of Changes
Other Study ID Numbers: Gelf-94
Study First Received: August 31, 2005
Last Updated: August 31, 2005
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lymphoma Study Association:
follicular lymphoma
CHVP + interferon
fludarabine
autotransplant

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Follicular
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Fludarabine
Fludarabine phosphate
Interferons
Anti-Infective Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014