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

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ClinicalTrials.gov Identifier: NCT00954005
Recruitment Status : Terminated (Predefined termination criterion of > 10 patients without CR or PR was matched.)
First Posted : August 6, 2009
Last Update Posted : August 19, 2015
Sponsor:
Information provided by (Responsible Party):
Martin Hoffmann, 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.

Condition or disease Intervention/treatment Phase
Indolent Lymphoma Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2003
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
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



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

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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00954005


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

Additional Information:
Responsible Party: Martin Hoffmann, Dr. Martin Hoffmann, Klinikum Ludwigshafen, German Low Grade Lymphoma Study Group
ClinicalTrials.gov Identifier: NCT00954005     History of Changes
Other Study ID Numbers: 001
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: August 19, 2015
Last Verified: August 2015

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

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Gemcitabine
Oxaliplatin
Rituximab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents