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Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

NCT00954005 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2015-08-19

No results posted yet for this study

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

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

Sponsors & Collaborators

  • German Low Grade Lymphoma Study Group

    lead OTHER

Principal Investigators

  • Martin Hoffmann, Dr. · German Low Grade Lymphoma Study Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2011-06-30
Completion
2012-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00954005 on ClinicalTrials.gov