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

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Groupe d'Etudes de Lymphomes de L'Adulte
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

MedlinePlus related topics:   Lymphoma   

ChemIDplus related topics:   Rituximab   

U.S. FDA Resources

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).

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


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

Publications:

Study ID Numbers:   RAIL, EUDRACT Number: 2005-002602-37
First Received:   September 12, 2005
Last Updated:   May 29, 2008
ClinicalTrials.gov Identifier:   NCT00169156
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  

Study placed in the following topic categories:
Lymphatic Diseases
Immunoproliferative Disorders
Rituximab
Immunoblastic Lymphadenopathy
Lymphoma, Large-Cell, Immunoblastic
Lymphoproliferative Disorders
Lymphoma
Lymphoma, large-cell, immunoblastic

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008




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