14-daily Oxaliplatin, Gemcitabine, Dexamethasone and Rituximab with subsequent 90-Y-Zevalin-consolidation for the treamtent of aggressive CD-20-positive B-NHL-relapses in patients with inability to tolerate high-dose chemotherapy - Zevalin-GemOxDex-R
- Conditions
- Relapse or primary progress of aggressive CD-20-positive-B-NHLMedDRA version: 8.1Level: LLTClassification code 10052314Term: Lymphatic disorder
- Registration Number
- EUCTR2005-005216-24-DE
- Lead Sponsor
- niversity of Saarland
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Patients with non-response to primary therapy or first relapse of an aggressive CD-20-positive-B-NHL after a CHOP-like-chemotherapy (Antracycline-containing), who are not qualified for a high-dose chemotherapy and autologous stem cell-transplantation
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
already initiated therapy of the lymphoma-relapse
CD-20-negative lymphomas
serious accompanying disorder or imparied organ function
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of efficacy of a combined chemotherapy with the the cytostatica Oxaliplatin, Gemcitabin, Dexamethason and Rituximab with following treatment of 90-Y-Zevalin in patients with relapse of an aggressive CD-20-positive-B-NHL or non-response to primary therapy.;Secondary Objective: Acquisition of adverse effects and life quality;Primary end point(s): the main endpoint is the secondary CR-rate after treatment with 90Y-Zevalin-GemOxDex-R
- Secondary Outcome Measures
Name Time Method