Status:
COMPLETED
ACVBP Plus Rituximab in Patients Aged From 18 to 59 Years With High-risk Diffuse Large B-cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Conditions:
Diffuse Large Cell Lymphoma
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
Brief Summary
This study is a multicentric trial evaluating the efficacy of R-ACVBP in patients aged 18 to 59 years with high risk diffuse large B-cell lymphoma
Detailed Description
This phase II non randomized study is based on the results of the LNH 98-5, LNH 87-2, LNH 93-3 and LNH 98-3B studies. To date, the ACVBP regimen is considered as the reference induction treatment of ...
Eligibility Criteria
Inclusion
- Patient with histologically proven CD20+ diffuse large B-cell lymphoma (WHO classification).
- Age from 18 to 59 years, eligible for transplant. Patient not previously treated. Age adjusted IPI = 2 or 3 With a minimum life expectancy of 3 months Negative HIV, HBV and HCV serologies \< 4 weeks (except after vaccination). Having signed a written informed consent.
Exclusion
- 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. Poor renal function (creatinin level \>150 mmol/l), poor hepatic function (total bilirubin level \>30 mmol/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.
- Any serious active disease (according to the investigator's decision). 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 :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT00144807
Start Date
December 1 2003
End Date
April 1 2012
Last Update
September 2 2015
Active Locations (13)
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1
Groupe d'Etude des Lymphomes de l'adulte
Mont-Godinne, Belgium
2
Polyclinique Bordeaux Nord
Bordeaux, France, 33300
3
Hôpital Henri Mondor
Créteil, France, 94010
4
Hématologie CHU de Lille
Lille, France, 59000