A Phase II Study of Rituximab Combined With CHOP in T-Cell Angio-Immunoblastic Lymphoma - Full Text View

Sponsor:	Groupe d'Etudes de Lymphomes de L'Adulte
Collaborator:	Hoffmann-La Roche
Information provided by:	Groupe d'Etudes de Lymphomes de L'Adulte
ClinicalTrials.gov Identifier:	NCT00169156

Purpose

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.

Condition	Intervention	Phase
Untreated T-Cell Angioimmunoblastic Lymphoma	Drug: Rituximab + CHOP regimen	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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).

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma

Drug Information available for: Rituximab

U.S. FDA Resources

Further study details as provided by Groupe d'Etudes de Lymphomes de L'Adulte:

Primary Outcome Measures:

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

Secondary Outcome Measures:

- 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.
- Overall survival (OS), time to progression (TTF) and disease-free survival (DFS).
- Safety of R-CHOP in this patient's population.
- Correlation between response rate, survival and biological informations (phenotype, EBV status, T/B clonality).
- Biological studies.

Estimated Enrollment:	25
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2009

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

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169156

Locations

France
Hôpital Henri Mondor
Créteil, France
Hôpital Saint Louis
Paris, France
Centre Henri Becquerel
Rouen, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France, 69495

Sponsors and Collaborators

Groupe d'Etudes de Lymphomes de L'Adulte

Hoffmann-La Roche

Investigators

Study Chair:	Corinne Haioun, MD	Hôpital Henri Mondor, Créteil, France
Principal Investigator:	Bertrand Joly, MD	C.H. Sud Francilien, Corbeil-Essonnes, France

More Information

Additional Information:

Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french) This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

Study ID Numbers:	RAIL, EUDRACT Number: 2005-002602-37
Study First Received:	September 12, 2005
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00169156 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Groupe d'Etudes de Lymphomes de L'Adulte:

T-cell angioimmunoblastic lymphoma
Rituximab

Additional relevant MeSH terms:

Immunoproliferative Disorders
Neoplasms by Histologic Type
Immune System Diseases
Immunologic Factors
Antineoplastic Agents
Rituximab
Immunoblastic Lymphadenopathy
Physiological Effects of Drugs

Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Therapeutic Uses
Lymphoproliferative Disorders
Antirheumatic Agents
Lymphoma

ClinicalTrials.gov processed this record on November 27, 2009