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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:
ClinicalTrials.gov Identifier:
NCT00169156
First Posted: September 15, 2005
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hoffmann-La Roche
Information provided by (Responsible Party):
Lymphoma Study Association
  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 Drug: Prednisone Drug: Doxorubicine Drug: Cyclophosphamide Drug: Vincristine Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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) [ Time Frame: 8 months (4 cycles of treatment + 4 cycles of consolidation) ]
    [Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment.


Secondary Outcome Measures:
  • 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 ]

Enrollment: 27
Actual Study Start Date: December 2005
Study Completion Date: November 2012
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Lymphoma Study Association
ClinicalTrials.gov Identifier: NCT00169156     History of Changes
Other Study ID Numbers: RAIL
2005-002602-37 ( EudraCT Number )
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Lymphoma
Immunoblastic Lymphadenopathy
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphadenopathy
Cyclophosphamide
Rituximab
Liposomal doxorubicin
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents
Glucocorticoids