Clinical trial · Interventional
A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
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).
NCT00169156CI-TRIAL-00026411completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Untreated T-cell Angioimmunoblastic Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicine | Drug | Doxorubicin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Rituximab + CHOP
- description
- Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
- interventionNames
- Drug: Rituximab
- Drug: Prednisone
- Drug: Doxorubicine
- Drug: Cyclophosphamide
- Drug: Vincristine
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- 8 months (4 cycles of treatment + 4 cycles of consolidation)
- description
- \[Complete response (CR), Complete response unconfirmed (CRu)\] after the end of treatment.
Secondary outcomes (5)
- measure
- Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDAttygalle A, Al-Jehani R, Diss TC, Munson P, Liu H, Du MQ, Isaacson PG, Dogan A. Neoplastic T cells in angioimmunoblastic T-cell lymphoma express CD10. Blood. 2002 Jan 15;99(2):627-33. doi: 10.1182/blood.v99.2.627. PMID 11781247
- BACKGROUNDLome-Maldonado C, Canioni D, Hermine O, Delabesse E, Damotte D, Raffoux E, Gaulard P, Macintyre E, Brousse N; French Groupe d'Etude des Lymphomes de l'Adulte (GELA). Angio-immunoblastic T cell lymphoma (AILD-TL) rich in large B cells and associated with Epstein-Barr virus infection. A different subtype of AILD-TL? Leukemia. 2002 Oct;16(10):2134-41. doi: 10.1038/sj.leu.2402642. PMID 12357368
- BACKGROUNDZettl A, Lee SS, Rudiger T, Starostik P, Marino M, Kirchner T, Ott M, Muller-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. doi: 10.1309/6UTX-GVC0-12ND-JJEU. PMID 11888076
- BACKGROUNDGisselbrecht C, Gaulard P, Lepage E, Coiffier B, Briere 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. PMID 9639502