Multicentric Phase I/II Study for the Efficacy of a Combination of Rituximab, Gemcitabine and Oxaliplatin in Relapsed/Refractory Indolent Lymphoma
Phase 1/Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Indolent Lymphoma
Both
Indolent Lymphoma
Trial Information
Multicentric Phase I/II Study for the Efficacy of a Combination of Rituximab, Gemcitabine and Oxaliplatin in Relapsed/Refractory Indolent Lymphoma
Inclusion Criteria:
- Need for therapy in patients with relapsed/refractory patients
- Histological proven diagnosis of an indolent B-cell lymphoma according to the World
Health Organization (WHO) classification belonging to one of the following entities:
- follicular lymphoma
- mantle cell lymphoma
- lymphoplasmacytic lymphoma
- nodal or splenic marginal zone lymphoma
- measurable disease
- lymphoma specific therapy in the last four weeks
- WHO performance grade 0, 1 or 2
Exclusion Criteria
- Patients suitable for high dose therapy
- Transformation in high grade lymphoma
- Leukocytes < 1,5/nl or platelets < 100/nl (except due to lymphoma)
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Remission Rate
Outcome Time Frame:
end of therapy
Safety Issue:
No
Principal Investigator
Martin Hoffmann, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
German Low Grade Lymphoma Study Group
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
001
NCT ID:
NCT00954005
Start Date:
January 2003
Completion Date:
June 2012
Related Keywords:
- Indolent Lymphoma
- relapsed indolent lymphoma
- gemcitabine
- oxaliplatin
- rituximab
- Lymphoma
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