Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

Indolent Lymphoma Clinical Trial

— R-GO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00954005
• Other study ID #: 001
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 4, 2009
• Last updated: August 17, 2015
• Start date: January 2003
• Est. completion date: June 2012

Study information

• Verified date: August 2015
• Source: German Low Grade Lymphoma Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: June 2012
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Indolent Lymphoma
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
Germany	Klinikum Ludwigshafen	Ludwigshafen

Sponsors (1)

Lead Sponsor	Collaborator
German Low Grade Lymphoma Study Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Remission Rate		end of therapy	No
Secondary	Progression Free Survival		5 years	No
Secondary	Median Overall Survival		5 years	No
Secondary	Toxicity	Number of Participants With Treatment-Related Adverse Events as Assessed by WHO Toxicity Grading Scale	5 years	Yes

External Links

•   web site in german language