Follicular Lymphoma Clinical Trial
Official title:
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
| Status | Completed |
| Enrollment | 400 |
| Est. completion date | January 2004 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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+ |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Groupe d'atude des lymphome de l'adulte | Yvoir | |
| France | Hôpital Henri Mondor | Créteil | |
| France | Centre Léon Bérard | Lyon | |
| France | Hôpital Saint Louis | Paris | |
| France | Service d'Hématologie - Centre Hospitalier Lyon-Sud | Pierre-Bénite cedex | |
| France | Centre Hospitalier Robert Debré | Reims | |
| France | Centre Henri Becquerel | Rouen | |
| France | Institut Gustave Roussy | Villejuif |
| Lead Sponsor | Collaborator |
|---|---|
| Lymphoma Study Association |
Belgium, France,
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 p — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival | |||
| Secondary | Overall survival | |||
| Secondary | Toxicity | |||
| Secondary | Response rates |
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