Status:
TERMINATED
R-ACVBP Versus R-CHOP in Patients Aged 60-65 With Diffuse Large B-cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Fondation ARC
Conditions:
Lymphoma, Large-Cell, Diffuse
Eligibility:
All Genders
60-65 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the efficacy of doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (ACVBP) plus rituximab in comparison to cyclophosphamide, doxorub...
Detailed Description
In Europe, 50% or more of new non-Hodgkin lymphoma cases occur in patients older than 60 years. More than 30% are diffuse large B-cell lymphomas (DLCL). The CHOP chemotherapy (cyclophosphamide, doxor...
Eligibility Criteria
Inclusion
- Patient with diffuse large B-cell lymphoma according to the WHO classification (anti CD20 labeling)
- Aged from 60 to 65 years.
- Not previously treated.
- Ann Arbor stage II, III, IV.
- ECOG performance status 0 to 2.
- Minimum life expectancy of 3 months.
- Negative HIV, hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies test 4 weeks (except after vaccination).
- Having previously signed a written informed consent.
Exclusion
- T-cell lymphoma.
- Any history of treated or non-treated indolent lymphoma. However, patients not previously diagnosed and having a diffuse large B-cell lymphoma with some small cell infiltration in bone marrow or lymph node may be included.
- Central nervous system or meningeal involvement by lymphoma.
- Contra-indication to any drug contained in the chemotherapy regimens.
- Any serious active disease (according to the investigator's decision).
- Poor renal function (creatinine level\>150micromol/l), poor hepatic function (total bilirubin level\>30mmol/l, transaminases\>2.5 maximum normal level) unless these abnormalities are related to the lymphoma.
- Poor bone marrow reserve as defined by neutrophils\<1.5G/l or platelets\<100G/l, unless related to bone marrow infiltration.
- Any history of cancer during the last 5 years with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma.
- Treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study.
- Adult patient under tutelage.
Key Trial Info
Start Date :
October 16 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 27 2010
Estimated Enrollment :
138 Patients enrolled
Trial Details
Trial ID
NCT00135499
Start Date
October 16 2001
End Date
April 27 2010
Last Update
August 23 2018
Active Locations (8)
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1
Groupe d'Etude des Lymphomes de l'adulte
Yvoir, Belgium
2
Hôpital Henri Mondor
Créteil, France, 94010
3
Hôpital Saint Louis
Paris, France, 75010
4
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France, 69495