Phase III multicentre open-label randomised study of ICE plus Rituximab (R-ICE) versus DHAP plus Rituximab (R-DHAP) in previously treated patients with CD 20 positive diffuse large B-cell lymphoma, eligible for transplantation followed by randomised maintenance treatment with Rituximab - Coral
- Conditions
- CD 20 positive diffuse large B cell lymphoma
- Registration Number
- EUCTR2004-002103-32-IE
- Lead Sponsor
- GELA-Recherche Clinique
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
Inclusion Criteria
Patients with CD20 positive diffuse large B-cell lymphoma.Disease must be histologically proven in case ofrelapse or partial response
Aged 18-65
Eligible for transplanatation
ECOG performance <=2
Previously treated with chemotherapy regimen containing anthracyclines with or without rituximab
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
Burkitt, mantle-cell and T-cell lymphoma
CD20 negative diffuse large cell lymphoma
Not previouly treated with anthracycline-containing regimens
Prior transplantation
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method