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

March 9, 2017 updated by: Lymphoma Study Association

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Créteil, France
        • Hopital Henri Mondor
      • Paris, France
        • Hôpital Saint Louis
      • Pierre-Bénite cedex, France, 69495
        • Service d'Hématologie - Centre Hospitalier Lyon-Sud
      • Rouen, France
        • Centre Henri Becquerel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rituximab + CHOP
Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 months (4 cycles of treatment + 4 cycles of consolidation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: 2 years
2 years
number of SAE
Time Frame: 2 years
2 years
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
2 years
Time to progression (TTF)
Time Frame: 2 years
2 years
Disease-free survival (DFS).
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lymphoma Study Association

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2005

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAIL
  • 2005-002602-37 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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