Status:
COMPLETED
A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Untreated T-cell Angioimmunoblastic Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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.
Detailed Description
This is a multicentric, open-label, non-randomized clinical study, evaluating the efficacy and the safety of a front-line treatment combining CHOP regimen and rituximab in patients aged 60 to 80 years...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00169156
Start Date
December 1 2005
End Date
November 1 2012
Last Update
March 13 2017
Active Locations (4)
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1
Hôpital Henri Mondor
Créteil, France
2
Hôpital Saint Louis
Paris, France
3
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69495
4
Centre Henri Becquerel
Rouen, France