Clinical trial NCT00169156: A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Untreated T-cell Angioimmunoblastic Lymphoma
Keywords: T-cell angioimmunoblastic lymphoma
Rituximab
Lead sponsor: Lymphoma Study Association
Sponsor class: OTHER
Collaborators: name: Hoffmann-La Roche
First posted: 2005-09-15
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: 8 months (4 cycles of treatment + 4 cycles of consolidation)
Secondary outcomes:
measure: Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
measure: Time to progression (TTF)
timeFrame: 2 years
measure: Disease-free survival (DFS).
timeFrame: 2 years
measure: number of SAE
timeFrame: 2 years
Other outcomes:
Locations:
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pierre-Bénite cedex
country: France
facility: Service d'Hématologie - Centre Hospitalier Lyon-Sud
city: Rouen
country: France
facility: Centre Henri Becquerel
Study officials:
affiliation: Hôpital Henri Mondor, Créteil, France
name: Corinne Haioun, MD
role: STUDY_CHAIR
affiliation: C.H. Sud Francilien, Corbeil-Essonnes, France
name: Bertrand Joly, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Attygalle 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.
citation: Lome-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.
citation: Zettl 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.
citation: Gisselbrecht 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.