Status:
TERMINATED
Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma
Lead Sponsor:
German Low Grade Lymphoma Study Group
Conditions:
Indolent Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the phase I part is to determine the tolerability, the initial safety profile and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent lymphoma. In the pha...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT00954005
Start Date
January 1 2003
End Date
June 1 2012
Last Update
August 19 2015
Active Locations (1)
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1
Klinikum Ludwigshafen
Ludwigshafen, Germany, 67063