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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00140569
Other study ID # Gelf-94
Secondary ID
Status Completed
Phase Phase 3
First received August 31, 2005
Last updated August 31, 2005
Start date January 1994
Est. completion date January 2004

Study information

Verified date August 2005
Source Lymphoma Study Association
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

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+

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
CHVP + interferon

Drug:
fludarabine

Procedure:
CHOP + TBI and autotransplant


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Lymphoma Study Association

Countries where clinical trial is conducted

Belgium,  France, 

References & Publications (1)

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

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival
Secondary Overall survival
Secondary Toxicity
Secondary Response rates
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