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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).


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Untreated T-Cell Angioimmunoblastic Lymphoma

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Trial Information

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).


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

Corinne Haioun, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hôpital Henri Mondor, Créteil, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

RAIL

NCT ID:

NCT00169156

Start Date:

September 2005

Completion Date:

December 2009

Related Keywords:

  • Untreated T-Cell Angioimmunoblastic Lymphoma
  • T-cell angioimmunoblastic lymphoma
  • Rituximab
  • Immunoblastic Lymphadenopathy
  • Lymphoma
  • Lymphoma, Large-Cell, Immunoblastic

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