Overview

This trial is active, not recruiting.

Condition untreated t-cell angioimmunoblastic lymphoma
Treatment rituximab + chop regimen
Phase phase 2
Sponsor Lymphoma Study Association
Collaborator Hoffmann-La Roche
Start date September 2005
End date December 2009
Trial size 25 participants
Trial identifier NCT00169156, EUDRACT Number: 2005-002602-37, RAIL

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Overall Response Rate (ORR) [Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment.
time frame:

Secondary Outcomes

Measure
- Event-free survival (EFS) at 2 years: events being death from any cause, relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.
time frame:
- Overall survival (OS), time to progression (TTF) and disease-free survival (DFS).
time frame:
- Safety of R-CHOP in this patient's population.
time frame:
- Correlation between response rate, survival and biological informations (phenotype, EBV status, T/B clonality).
time frame:
- Biological studies.
time frame:

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Study of the Efficacy and the Safety of First Line Treatment With CHOP Plus Rituximab (R-CHOP) in Patients Aged 60 to 80 Years With Previously Untreated T-Cell Angioimmunoblastic Lymphoma (AIL).
Principal investigator Bertrand Joly, MD
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 with previously untreated AIL. It is anticipated that 25 subjects will be enrolled over 2 years (from 2005 / 2007).Analysis performed every 5 patients (based on triangular test). The duration of the treatment period is approximately 25 weeks and patients are followed until Death. The total Duration of the study is expected to be 2.5 years.
Trial information was received from ClinicalTrials.gov and was last updated in May 2008.
Information provided to ClinicalTrials.gov by Lymphoma Study Association.