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

Primary Purpose

Untreated T-cell Angioimmunoblastic Lymphoma

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Rituximab
Prednisone
Doxorubicine
Cyclophosphamide
Vincristine
Sponsored by
Lymphoma Study Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Untreated T-cell Angioimmunoblastic Lymphoma focused on measuring T-cell angioimmunoblastic lymphoma, Rituximab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hôpital Henri Mondor
  • Hôpital Saint Louis
  • Service d'Hématologie - Centre Hospitalier Lyon-Sud
  • Centre Henri Becquerel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab + CHOP

Arm Description

Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR)
[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.
Events being death from any cause
Overall survival (OS)
Time to progression (TTF)
Disease-free survival (DFS).
number of SAE

Full Information

First Posted
September 12, 2005
Last Updated
March 9, 2017
Sponsor
Lymphoma Study Association
Collaborators
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT00169156
Brief Title
A Phase II Study of Rituximab Combined With CHOP in T-cell Angio-immunoblastic Lymphoma
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).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
December 2005 (Actual)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lymphoma Study Association
Collaborators
Hoffmann-La Roche

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Untreated T-cell Angioimmunoblastic Lymphoma
Keywords
T-cell angioimmunoblastic lymphoma, Rituximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab + CHOP
Arm Type
Experimental
Arm Description
Rituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
375 mg/m2 D1
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
40 mg/m2 D1 to D5
Intervention Type
Drug
Intervention Name(s)
Doxorubicine
Intervention Description
50 mg/m2 D1
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
750 mg/m2 D1
Intervention Type
Drug
Intervention Name(s)
Vincristine
Intervention Description
1,4 mg/m2 D1
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
[Complete response (CR), Complete response unconfirmed (CRu)] after the end of treatment.
Time Frame
8 months (4 cycles of treatment + 4 cycles of consolidation)
Secondary Outcome Measure Information:
Title
Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.
Description
Events being death from any cause
Time Frame
2 years
Title
Overall survival (OS)
Time Frame
2 years
Title
Time to progression (TTF)
Time Frame
2 years
Title
Disease-free survival (DFS).
Time Frame
2 years
Title
number of SAE
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Haioun, MD
Organizational Affiliation
Hôpital Henri Mondor, Créteil, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bertrand Joly, MD
Organizational Affiliation
C.H. Sud Francilien, Corbeil-Essonnes, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Henri Mondor
City
Créteil
Country
France
Facility Name
Hôpital Saint Louis
City
Paris
Country
France
Facility Name
Service d'Hématologie - Centre Hospitalier Lyon-Sud
City
Pierre-Bénite cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11781247
Citation
Attygalle A, Al-Jehani R, Diss TC, Munson P, Liu H, Du MQ, Isaacson PG, Dogan A. Neoplastic T cells in angioimmunoblastic T-cell lymphoma express CD10. Blood. 2002 Jan 15;99(2):627-33. doi: 10.1182/blood.v99.2.627.
Results Reference
background
PubMed Identifier
12357368
Citation
Lome-Maldonado C, Canioni D, Hermine O, Delabesse E, Damotte D, Raffoux E, Gaulard P, Macintyre E, Brousse N; French Groupe d'Etude des Lymphomes de l'Adulte (GELA). Angio-immunoblastic T cell lymphoma (AILD-TL) rich in large B cells and associated with Epstein-Barr virus infection. A different subtype of AILD-TL? Leukemia. 2002 Oct;16(10):2134-41. doi: 10.1038/sj.leu.2402642.
Results Reference
background
PubMed Identifier
11888076
Citation
Zettl A, Lee SS, Rudiger T, Starostik P, Marino M, Kirchner T, Ott M, Muller-Hermelink HK, Ott G. Epstein-Barr virus-associated B-cell lymphoproliferative disorders in angloimmunoblastic T-cell lymphoma and peripheral T-cell lymphoma, unspecified. Am J Clin Pathol. 2002 Mar;117(3):368-79. doi: 10.1309/6UTX-GVC0-12ND-JJEU.
Results Reference
background
PubMed Identifier
9639502
Citation
Gisselbrecht C, Gaulard P, Lepage E, Coiffier B, Briere J, Haioun C, Cazals-Hatem D, Bosly A, Xerri L, Tilly H, Berger F, Bouhabdallah R, Diebold J. Prognostic significance of T-cell phenotype in aggressive non-Hodgkin's lymphomas. Groupe d'Etudes des Lymphomes de l'Adulte (GELA). Blood. 1998 Jul 1;92(1):76-82.
Results Reference
background
Links:
URL
http://www.gela.org
Description
Official site of the Groupe d'Etude des Lymphomes de l'Adulte (In french)

Learn more about this trial

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

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