Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

Phase 1

Terminated

• Conditions: Indolent Lymphoma
• Interventions: Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin

• Registration Number: NCT00954005
• Lead Sponsor: German Low Grade Lymphoma Study Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-04
• Study First Posted: 2009-08-06
• Primary Completion: 2011-06
• Study Completion: 2012-06
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-17
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rituximab, Gemcitabine and Oxaliplatin	Therapy with 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

Primary Outcome Measures

Name	Time	Method
Overall Remission Rate	end of therapy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Klinikum Ludwigshafen; 🇩🇪 Ludwigshafen, Germany