Trial | NCT00140569  Report issue

Official Title

Randomized Study for Patients With Follicular Lymphoma Needing Treatment

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    400
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
Study Started
Jan 31
1994
Study Completion
Jan 31
2004
Last Update
Sep 01
2005
Estimate

Procedure CHVP + interferon

Drug fludarabine

Procedure CHOP + TBI and autotransplant

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+
No Results Posted