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Randomized Study for Patients With Follicular Lymphoma Needing Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00140569
First Posted: September 1, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Lymphoma Study Association
August 31, 2005
September 1, 2005
December 9, 2005
January 1994
Not Provided
Progression-free survival
Same as current
No Changes Posted
  • Overall survival
  • Toxicity
  • Response rates
Same as current
Not Provided
Not Provided
 
Randomized Study for Patients With Follicular Lymphoma Needing Treatment
Randomized Study for Patients With Follicular Lymphoma Needing Treatment

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

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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Follicular Lymphoma
  • Procedure: CHVP + interferon
  • Drug: fludarabine
  • Procedure: CHOP + TBI and autotransplant
Not Provided
Coiffier B, Neidhardt-Bérard EM, Tilly H, Belanger C, Bouabdallah R, Haioun C, Brice P, Péaud PY, Pico JL, Janvier M, Solal-Celigny P, Brousse N. Fludarabine alone compared to CHVP plus interferon in elderly patients with follicular lymphoma and adverse prognostic parameters: a GELA study. Groupe d'Etudes des Lymphomes de l'Adulte. Ann Oncol. 1999 Oct;10(10):1191-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
January 2004
Not Provided

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+
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
 
NCT00140569
Gelf-94
Not Provided
Not Provided
Not Provided
Not Provided
Lymphoma Study Association
Not Provided
Study Chair: Bertrand Coiffier, MD Hospices Civils de Lyon
Principal Investigator: Catherine Sebban, MD Centre Leon Berard
Lymphoma Study Association
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP