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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005216-24-DE
Enrollment
Unknown
Registered
2006-10-10
Start date
2009-06-09
Completion date
Unknown
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapse or primary progress of aggressive CD-20-positive-B-NHL MedDRA version: 8.1 Level: LLT Classification code 10052314 Term: Lymphatic disorder

Interventions

Trade Name: Mabthera Product Name: Mabthera Pharmaceutical Form: Concentrate for solution for infusion Other descriptive name: RITUXIMAB Trade Name: Zevalin Product Name: Zevalin Pharmaceutical Form:

Sponsors

University of Saarland
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: already initiated therapy of the lymphoma-relapse CD-20-negative lymphomas serious accompanying disorder or imparied organ function

Design outcomes

Primary

MeasureTime frame
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—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026