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 phase II part the investigators want to estimate the activity of gemcitabine and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
56
Rituximab 375 mg/m² day 0 or 1, Gemcitabine 1.000 mg/m² in 30 Min. day 1 and 15, Oxaliplatin 70 mg/m² in 120 Min. day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²), repetition at day 29 for 4 cycles
Klinikum Ludwigshafen
Ludwigshafen, Germany
Overall Remission Rate
Time frame: end of therapy
Progression Free Survival
Time frame: 5 years
Median Overall Survival
Time frame: 5 years
Toxicity
Number of Participants With Treatment-Related Adverse Events as Assessed by WHO Toxicity Grading Scale
Time frame: 5 years
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