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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Lymphoma Study Association

Current Primary Outcome: 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.


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

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • - 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.


Information By: Lymphoma Study Association

Dates:
Date Received: September 12, 2005
Date Started: December 2005
Date Completion:
Last Updated: March 9, 2017
Last Verified: March 2017