Status:
COMPLETED
ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1
Lead Sponsor:
Lymphoma Study Association
Collaborating Sponsors:
Amgen
Conditions:
Diffuse Large-Cell Lymphoma
Eligibility:
All Genders
18-59 years
Phase:
PHASE3
Brief Summary
This study is a multicentric randomized trial evaluating the efficacy of the combination ACVBP+rituximab compared to the combination of CHOP+rituximab in patients aged from 18 to 59 years with diffuse...
Detailed Description
This phase III multicentric open label randomized study is based on the results of previous LNH 93-5 and LNH98-5 studies. The LNH93-5 study has shown that the ACVBP regimen gave a longer EFS (39% vs ...
Eligibility Criteria
Inclusion
- Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification) Aged from 18 to 59 years. Age-adjusted International Prognostic Index equal to 1 (elevated LDH level OR stage III-IV OR ECOG status 2-3-4).
- Patient not previously treated. With a minimum life expectancy of 3 months. Negative HIV, HBV and HCV serologies test 4 weeks (except after vaccination). Having previously signed a written informed consent.
Exclusion
- Any other histological type of 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 (creatinin level\>150µmol/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 \<1.5 G/l or platelets \<100 G/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.
- Pregnant or lactating women. Adult patient under tutelage.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2009
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00140595
Start Date
December 1 2003
End Date
January 1 2009
Last Update
March 4 2011
Active Locations (10)
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1
Groupe d'étude des lymphomes de l'adulte
Yvoir, Belgium
2
Hôpital Henri Mondor
Créteil, France, 94010
3
Centre Léon Bérard
Lyon, France, 69008
4
Hôpital Saint Louis
Paris, France, 75010