A randomized phase III study on the effect of the chimeric anti-CD20 monoclonal antibody (MabThera) during sequential chemotherapy followed by autologous stem cell transplantation in patients with relapsed or progressive B-cell non-Hodgkin’s lymphoma.
Completed
- Conditions
- on Hodgkin’s Lymphoma
- Registration Number
- NL-OMON29096
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. Malignant lymphoma based upon a representative histology specimen according to the REAL classification at relapse or progression: Follicular center lymphoma, follicular (grade III), Diffuse large B-cell lymphoma, Primary mediastinal B-cell lymphoma;
2. CD20 positive;
Exclusion Criteria
1. Patients with history of intolerance of exogenous protein administration;
2. Patients with severe cardiac dysfunction (NYHA classification II-IV);
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival measured from the date of registration. Patients still alive or lost to follow up are censored at the last day they were known to be alive.
- Secondary Outcome Measures
Name Time Method 1. Response to DHAP-VIM with or without rituximab (MabTheraâ);<br /><br>2. Event-free survival (i.e. time from registration to the date of stable disease after both the first and second reinduction cycle, documented progression, relapse or death, whichever comes first).