Status:
TERMINATED
Efficacy Study of Rituximab After ASCT in High-Risk Diffuse Large B-Cell Lymphoma
Lead Sponsor:
Lymphoma Study Association
Conditions:
CD20-Positive Large B-Cell Lymphoma
Eligibility:
All Genders
18-59 years
Phase:
PHASE3
Brief Summary
Rituximab vs observation after high-dose consolidative first-line chemotherapy (HDC) with autologous stem cell transplantation in poor risk diffuse large B-cell lymphoma.
Detailed Description
This is a multicentric, open-label, randomized clinical study, evaluating the efficacy and the safety of Rituximab After ASCT in patients aged 18 to 59 years with previously untreated High-Risk (aa-IP...
Eligibility Criteria
Inclusion
- Patient with histologically proven CD20+ diffuse large B cell lymphoma (WHO Classification).
- Aged from 18 to 59 years, eligible for transplant.
- Patient not previously treated.
- Age adjusted International Prognostic Index equal to 2 or 3.
- Having previously signed a written informed consent.
- Women of childbearing potential currently practicing an adequate method of contraception.
Exclusion
- Any other histological type of lymphoma.
- Any history of treated or non-treated indolent lymphoma.
- Central nervous system or meningeal involvement by lymphoma.
- Contra-indication to any drug contained in the chemotherapy regimens.
- Poor renal function (creatinin level\>150mmol/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.
- Any serious active disease (according to the investigator's decision).
- HIV, HTLV1 or HBV related disease.
- Any organ transplantation before inclusion.
- Pregnant women.
Key Trial Info
Start Date :
October 1 1999
Trial Type :
INTERVENTIONAL
End Date :
August 1 2005
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00169169
Start Date
October 1 1999
End Date
August 1 2005
Last Update
September 15 2005
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital Henri Mondor
Créteil, France
2
Hôpital Saint Louis
Paris, France
3
Service d'Hématologie - Centre Hospitalier Lyon-Sud
Pierre-Bénite, France
4
Centre Henri Becquerel
Rouen, France