A randomized phase III study of chimeric anti-CD20 monoclonal antibody (Rituximab) with 2-weekly CHOP chemotherapy (CHOP 14) in elderly patients with intermediate- or high-risk non-Hodgkin’s lymphoma.
Completed
- Conditions
- on Hodgkin’s Lymphoma
- Registration Number
- NL-OMON28411
- 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
- 400
Inclusion Criteria
1. Patients with a confirmed histologic diagnosis of NHL according to the WHO classification: Mantle cell lymphoma (MCL), Follicular lymphoma (grade III) (FL III) or Diffuse large B-cell lymphoma (DLBCL);
2. Low-intermediate, high-intermediate or high risk NHL according to age-adjusted IPI score;
Exclusion Criteria
1. Intolerance of exogenous protein administration;
2. Severe cardiac dysfunction (NYHA classification II-IV) or LVEF < 45 %;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free survival (i.e. time from registration to induction failure (i.e. no CR or CRu on induction treatment), death or relapse whichever occurs first); the time to failure of patients with induction failure is set at one day.
- Secondary Outcome Measures
Name Time Method 1. Complete response;<br><br />2. Overall survival measured form the time of registration;<br><br />3. Disease-free interval (duration of the first CR) measured from the time of achievement of CR to day of relapse or death from any cause (whichever occurs first);<br><br />4. Toxicity.