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

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

May 29, 2008

Start Date ^ICMJE

September 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00169156 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

- 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.

Original Secondary Outcome Measures ^ICMJE

- 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.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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).

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Untreated T-Cell Angioimmunoblastic Lymphoma

Intervention ^ICMJE

Drug: Rituximab + CHOP regimen

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00169156

Responsible Party

Study ID Numbers ^ICMJE

RAIL, EUDRACT Number: 2005-002602-37

Study Sponsor ^ICMJE

Groupe d'Etudes de Lymphomes de L'Adulte

Collaborators ^ICMJE

Hoffmann-La Roche

Investigators ^ICMJE

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

Information Provided By

Groupe d'Etudes de Lymphomes de L'Adulte

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP