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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Lymphoma Study Association.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00169156
First received: September 12, 2005
Last updated: May 29, 2008
Last verified: May 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


Further study details as provided by Lymphoma Study Association:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Hôpital Henri Mondor
Créteil, France
Hôpital Saint Louis
Paris, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite cedex, France, 69495
Centre Henri Becquerel
Rouen, France
Sponsors and Collaborators
Lymphoma Study Association
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:
Publications:
ClinicalTrials.gov Identifier: NCT00169156     History of Changes
Other Study ID Numbers: RAIL, EUDRACT Number: 2005-002602-37
Study First Received: September 12, 2005
Last Updated: May 29, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lymphoma Study Association:
T-cell angioimmunoblastic lymphoma
Rituximab

Additional relevant MeSH terms:
Immunoblastic Lymphadenopathy
Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 19, 2014