NCT00954005

Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

Multicentric Phase I/II Study for the Efficacy of a Combination of Rituximab, Gemcitabine and Oxaliplatin in Relapsed/Refractory Indolent Lymphoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: German Low Grade Lymphoma Study Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Indolent Lymphoma

Interventions

Type	Name	Description
DRUG	Therapy with Rituximab, Gemcitabine and Oxaliplatin	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

Timeline

• Start date: 2003-01-01
• Primary completion: 2011-06-01
• Completion: 2012-06-01
• First posted: 2009-08-06
• Last updated: 2015-08-19

Locations

1 site across 1 country: Germany