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CompletedNCT00140569Updated Sep 1, 2005

Randomized Study for Patients With Follicular Lymphoma Needing Treatment

A Phase 3 interventional study of CHVP + interferon and fludarabine in Follicular Lymphoma, sponsored by Lymphoma Study Association. Completed at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-09-01.

Sponsored by Lymphoma Study Association · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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
Read the 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
02

Conditions studied

  • Follicular Lymphoma

Keywords

  • follicular lymphoma
  • CHVP + interferon
  • fludarabine
  • autotransplant
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 400 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Lymphoma Study Association is the lead sponsor of 26 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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+
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants

Interventions

  • ProcedureCHVP + interferon
  • Drugfludarabine
  • ProcedureCHOP + TBI and autotransplant
06

What researchers measure

Primary outcomes

  1. Progression-free survival

Secondary outcomes

  1. Overall survival

  2. Toxicity

  3. Response rates

07

Study locations

8 sites
  • Groupe d'atude des lymphome de l'adulte
    Yvoir, Belgium
  • Hôpital Henri Mondor
    Créteil, 94010, France
  • Centre Léon Bérard
    Lyon, 69008, France
  • Hôpital Saint Louis
    Paris, 75010, France
  • Service d'Hématologie - Centre Hospitalier Lyon-Sud
    Pierre-Bénite cedex, 69495, France
  • Centre Hospitalier Robert Debré
    Reims, 51092, France
  • Centre Henri Becquerel
    Rouen, 76038, France
  • Institut Gustave Roussy
    Villejuif, France
08

References and documents

Publications

  • Coiffier B, Neidhardt-Berard EM, Tilly H, Belanger C, Bouabdallah R, Haioun C, Brice P, Peaud 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. doi: 10.1023/a:1008347425795. PubMed 10586336 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00140569
Lead sponsor
Lymphoma Study Association
First posted
Sep 1, 2005
Start date
Jan 1994
Completion
Jan 2004
Last update
Sep 1, 2005

Study contacts

Bertrand Coiffier, MD
study chair · Hospices Civils de Lyon
Catherine Sebban, MD
principal investigator · Centre Leon Berard
View the source record on ClinicalTrials.gov ↗

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