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

Primary Purpose

Indolent Lymphoma

Status
Terminated
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Therapy with Rituximab, Gemcitabine and Oxaliplatin
Sponsored by
German Low Grade Lymphoma Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Indolent Lymphoma focused on measuring relapsed indolent lymphoma, gemcitabine, oxaliplatin, rituximab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Klinikum Ludwigshafen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rituximab, Gemcitabine and Oxaliplatin

Arm Description

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

Outcomes

Primary Outcome Measures

Overall Remission Rate

Secondary Outcome Measures

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

Full Information

First Posted
August 4, 2009
Last Updated
August 17, 2015
Sponsor
German Low Grade Lymphoma Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00954005
Brief Title
Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Predefined termination criterion of > 10 patients without CR or PR was matched.
Study Start Date
January 2003 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
German Low Grade Lymphoma Study Group

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indolent Lymphoma
Keywords
relapsed indolent lymphoma, gemcitabine, oxaliplatin, rituximab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rituximab, Gemcitabine and Oxaliplatin
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Therapy with Rituximab, Gemcitabine and Oxaliplatin
Other Intervention Name(s)
Rituximab = Mabthera, Rituxan, Gemcitabine = Gemzar, Oxaliplatin = Eloxatin
Intervention Description
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
Primary Outcome Measure Information:
Title
Overall Remission Rate
Time Frame
end of therapy
Secondary Outcome Measure Information:
Title
Progression Free Survival
Time Frame
5 years
Title
Median Overall Survival
Time Frame
5 years
Title
Toxicity
Description
Number of Participants With Treatment-Related Adverse Events as Assessed by WHO Toxicity Grading Scale
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Hoffmann, Dr.
Organizational Affiliation
German Low Grade Lymphoma Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Ludwigshafen
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma

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