Untreated T-cell Angioimmunoblastic Lymphoma Clinical Trial
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).
| Verified date | March 2017 |
| Source | Lymphoma Study Association |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 27 |
| Est. completion date | November 2012 |
| Est. primary completion date | December 2008 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| France | Hôpital Henri Mondor | Créteil | |
| France | Hôpital Saint Louis | Paris | |
| France | Service d'Hématologie - Centre Hospitalier Lyon-Sud | Pierre-Bénite cedex | |
| France | Centre Henri Becquerel | Rouen |
| Lead Sponsor | Collaborator |
|---|---|
| Lymphoma Study Association | Hoffmann-La Roche |
France,
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Gisselbrecht C, Gaulard P, Lepage E, Coiffier B, Brière J, Haioun C, Cazals-Hatem D, Bosly A, Xerri L, Tilly H, Berger F, Bouhabdallah R, Diebold J. Prognostic significance of T-cell phenotype in aggressive non-Hodgkin's lymphomas. Groupe d'Etudes des Lymphomes de l'Adulte (GELA). Blood. 1998 Jul 1;92(1):76-82. — View Citation
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Zettl A, Lee SS, Rüdiger T, Starostik P, Marino M, Kirchner T, Ott M, Müller-Hermelink HK, Ott G. Epstein-Barr virus-associated B-cell lymphoproliferative disorders in angloimmunoblastic T-cell lymphoma and peripheral T-cell lymphoma, unspecified. Am J Clin Pathol. 2002 Mar;117(3):368-79. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Response Rate (ORR) | [Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment. | 8 months (4 cycles of treatment + 4 cycles of consolidation) | |
| Secondary | Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment. | Events being death from any cause | 2 years | |
| Secondary | Overall survival (OS) | 2 years | ||
| Secondary | Time to progression (TTF) | 2 years | ||
| Secondary | Disease-free survival (DFS). | 2 years | ||
| Secondary | number of SAE | 2 years |