A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years with previously untreated AIL.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lymphoma Study Association
• Collaborator: Hoffmann-La Roche
• Treatments: Cyclophosphamide; Doxorubicin; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• Patients with histologically proven T-cell angioimmunoblastic lymphoma (AIL) on lymph node biopsy.

• Aged from 60 to 80 years.

• Patient not previously treated (except corticosteroids providing they have been initiated less than 10 days before inclusion).

• ECOG performance status 0 to 2.

• With a minimum of life expectancy > 3 months.

• Negative HIV, HBV and HCV serological tests < 4 weeks (except after vaccination).

• Having previously signed a written informed consent.

Exclusion Criteria:

• Any other histological type of T-cell lymphoma.

• Central nervous system or meningeal involvement by lymphoma.

• Contra-indication to any drug included in the R-CHOP regimen.

• Concurrent severe disease (according to the investigator's decision).

• Active bacterial, viral or fungal infection.

• Poor renal function (serum creatinine level > 150 µmol/L) or impaired liver function tests (total bilirubin level > 30 µmol/L, transaminases > 2.5 upper normal limits) unless they are related to the lymphoma.

• Poor bone marrow reserve as defined by neutrophils < 1.5 x 109/L or platelets < 100 x 109/L, unless related to bone marrow infiltration.

• Any history of cancer during the last 5 years, with the exception of non basal cell carcinoma of the skin or in situ carcinoma of the cervix.

• Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.

• Patient under tutelage.