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Status:

COMPLETED

Randomized Study for Patients With Follicular Lymphoma Needing Treatment

Lead Sponsor:

Lymphoma Study Association

Conditions:

Follicular Lymphoma

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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): rand...

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): rand...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

January 1 1994

Trial Type :

INTERVENTIONAL

End Date :

January 1 2004

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT00140569

Start Date

January 1 1994

End Date

January 1 2004

Last Update

September 1 2005

Active Locations (8)

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Page 1 of 2 (8 locations)

1

Groupe d'atude des lymphome de l'adulte

Yvoir, Belgium

2

Hôpital Henri Mondor

Créteil, France, 94010

3

Centre Léon Bérard

Lyon, France, 69008

4

Hôpital Saint Louis

Paris, France, 75010