Overview

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.