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

This study has been terminated.
(Predefined termination criterion of > 10 patients without CR or PR was matched.)
Information provided by (Responsible Party):
Martin Hoffmann, German Low Grade Lymphoma Study Group Identifier:
First received: August 4, 2009
Last updated: August 17, 2015
Last verified: August 2015
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 Intervention Phase
Indolent Lymphoma
Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Martin Hoffmann, German Low Grade Lymphoma Study Group:

Primary Outcome Measures:
  • Overall Remission Rate [ Time Frame: end of therapy ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 5 years ]
  • Median Overall Survival [ Time Frame: 5 years ]
  • Toxicity [ Time Frame: 5 years ]
    Number of Participants With Treatment-Related Adverse Events as Assessed by WHO Toxicity Grading Scale

Enrollment: 56
Study Start Date: January 2003
Study Completion Date: June 2012
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00954005

Klinikum Ludwigshafen
Ludwigshafen, Germany, 67063
Sponsors and Collaborators
German Low Grade Lymphoma Study Group
Principal Investigator: Martin Hoffmann, Dr. German Low Grade Lymphoma Study Group
  More Information

Additional Information:
Responsible Party: Martin Hoffmann, Dr. Martin Hoffmann, Klinikum Ludwigshafen, German Low Grade Lymphoma Study Group Identifier: NCT00954005     History of Changes
Other Study ID Numbers: 001
Study First Received: August 4, 2009
Last Updated: August 17, 2015

Keywords provided by Martin Hoffmann, German Low Grade Lymphoma Study Group:
relapsed indolent lymphoma

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on May 25, 2017