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A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Lymphoma Study Association
ClinicalTrials.gov Identifier:
NCT00169156
First received: September 12, 2005
Last updated: March 9, 2017
Last verified: March 2017

September 12, 2005
March 9, 2017
December 2005
December 2008   (Final data collection date for primary outcome measure)
Overall Response Rate (ORR) [ Time Frame: 8 months (4 cycles of treatment + 4 cycles of consolidation) ]
[Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment.
Overall Response Rate (ORR) [Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment.
Complete list of historical versions of study NCT00169156 on ClinicalTrials.gov Archive Site
  • Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment. [ Time Frame: 2 years ]
    Events being death from any cause
  • Overall survival (OS) [ Time Frame: 2 years ]
  • Time to progression (TTF) [ Time Frame: 2 years ]
  • Disease-free survival (DFS). [ Time Frame: 2 years ]
  • number of SAE [ Time Frame: 2 years ]
  • - 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.
Not Provided
Not Provided
 
A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
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).
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.

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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Untreated T-cell Angioimmunoblastic Lymphoma
  • Drug: Rituximab
    375 mg/m2 D1
  • Drug: Prednisone
    40 mg/m2 D1 to D5
  • Drug: Doxorubicine
    50 mg/m2 D1
  • Drug: Cyclophosphamide
    750 mg/m2 D1
  • Drug: Vincristine
    1,4 mg/m2 D1
Experimental: Rituximab + CHOP
Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
Interventions:
  • Drug: Rituximab
  • Drug: Prednisone
  • Drug: Doxorubicine
  • Drug: Cyclophosphamide
  • Drug: Vincristine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
November 2012
December 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00169156
RAIL
2005-002602-37 ( EudraCT Number )
Yes
Not Provided
No
Not Provided
Lymphoma Study Association
Lymphoma Study Association
Hoffmann-La Roche
Study Chair: Corinne Haioun, MD Hôpital Henri Mondor, Créteil, France
Principal Investigator: Bertrand Joly, MD C.H. Sud Francilien, Corbeil-Essonnes, France
Lymphoma Study Association
March 2017

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