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).
2 other identifiers
interventional
27
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2005
Longer than P75 for phase_2
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedStudy Start
First participant enrolled
December 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedMarch 13, 2017
March 1, 2017
3 years
September 12, 2005
March 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Response Rate (ORR)
\[Complete response (CR), Complete response unconfirmed (CRu)\] after the end of treatment.
8 months (4 cycles of treatment + 4 cycles of consolidation)
Secondary Outcomes (5)
Event-free survival (EFS) relapse for complete responders, disease progression, early discontinuation of treatment for toxicity or modification of treatment.
2 years
Overall survival (OS)
2 years
Time to progression (TTF)
2 years
Disease-free survival (DFS).
2 years
number of SAE
2 years
Study Arms (1)
Rituximab + CHOP
EXPERIMENTALRituximab + CHOP regimen Prednisone - Doxorubicine - Cyclophosphamide - Vincristine
Interventions
Eligibility Criteria
You may qualify if:
- Patients with histologically proven T-cell angioimmunoblastic lymphoma (AIL) on lymph node biopsy.
- Aged from 60 to 80 years.
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lymphoma Study Associationlead
- Hoffmann-La Rochecollaborator
Study Sites (4)
Hôpital Henri Mondor
Créteil, France
Hôpital Saint Louis
Paris, France
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, 69495, France
Centre Henri Becquerel
Rouen, France
Related Publications (4)
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.
PMID: 11781247BACKGROUNDLome-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.
PMID: 12357368BACKGROUNDZettl 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.
PMID: 11888076BACKGROUNDGisselbrecht 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.
PMID: 9639502BACKGROUND
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Corinne Haioun, MD
Hôpital Henri Mondor, Créteil, France
- PRINCIPAL INVESTIGATOR
Bertrand Joly, MD
C.H. Sud Francilien, Corbeil-Essonnes, France
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Study Start
December 1, 2005
Primary Completion
December 1, 2008
Study Completion
November 1, 2012
Last Updated
March 13, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share