R-GO: Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

Sponsor

German Low Grade Lymphoma Study Group (Other)

Overall Status

Terminated

CT.gov ID

NCT00954005

Collaborator

(none)

Enrollment

Location

Arm

113

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Indolent Lymphoma	Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2003

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Rituximab, Gemcitabine and Oxaliplatin Drug: Rituximab on day 0 or 1 of each 28-day cycle Drug: Gemcitabine on day 1 and 15 of each 28-day cycle Drug: Oxaliplatin on day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²) of each 28-day cycle	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 Other Names: Rituximab = Mabthera, Rituxan Gemcitabine = Gemzar Oxaliplatin = Eloxatin

Arm

Intervention/Treatment

Experimental: Rituximab, Gemcitabine and Oxaliplatin

Drug: Rituximab on day 0 or 1 of each 28-day cycle Drug: Gemcitabine on day 1 and 15 of each 28-day cycle Drug: Oxaliplatin on day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²) of each 28-day cycle

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

Other Names:

Rituximab = Mabthera, Rituxan

Gemcitabine = Gemzar

Oxaliplatin = Eloxatin

Outcome Measures

Primary Outcome Measures

Overall Remission Rate [end of therapy]

Secondary Outcome Measures

Progression Free Survival [5 years]
Median Overall Survival [5 years]
Toxicity [5 years]
Number of Participants With Treatment-Related Adverse Events as Assessed by WHO Toxicity Grading Scale