Randomized Study for Patients With Follicular Lymphoma Needing Treatment

Phase 3

Completed

• Conditions: Follicular Lymphoma

• Registration Number: NCT00140569
• Lead Sponsor: Lymphoma Study Association

Brief Summary

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

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

Study Timeline

• Study Start: 1994-01
• Study Completion: 2004-01
• Status Verified: 2005-08
• Study First Submitted: 2005-08-31
• Study First Submitted QC: 2005-08-31
• Last Update Submitted: 2005-08-31
• Study First Posted: 2005-09-01
• Last Update Posted: 2005-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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)

Read More

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+

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression-free survival

Secondary Outcome Measures

Name	Time	Method
Overall survival
Toxicity
Response rates

Trial Locations

Locations (8)

Groupe d'atude des lymphome de l'adulte; 🇧🇪 Yvoir, Belgium

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Centre Léon Bérard; 🇫🇷 Lyon, France

Hôpital Saint Louis; 🇫🇷 Paris, France

Centre Hospitalier Robert Debré; 🇫🇷 Reims, France

Service d'Hématologie - Centre Hospitalier Lyon-Sud; 🇫🇷 Pierre-Bénite cedex, France

Centre Henri Becquerel; 🇫🇷 Rouen, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France