Efficacy of maintenance therapy with rituximab after induction chemotherapy (R-CHOP vs R-FC) for elderly patients with mantle cell lymphoma not suitable for autologous stem cell transplantation - MCL elderly
- Conditions
- Mantle cell lymphoma
- Registration Number
- EUCTR2005-005375-15-BE
- Lead Sponsor
- GELA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 570
Inclusion Criteria
- Patients with histologically confirmed mantle cell lymphoma
- Advanced stages II-IV
- Previously untreated
- 65 years and older or 60-65 if not eligible for high dose chemotherapy
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) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-WHO performance status of 3 or more
-Known anti-murine antibody (HAMA) reactivity or Known hypersensitivity to murine antibodies
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