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.)
Sponsor:
Information provided by (Responsible Party):
Martin Hoffmann, German Low Grade Lymphoma Study Group
ClinicalTrials.gov Identifier:
NCT00954005
First received: August 4, 2009
Last updated: August 17, 2015
Last verified: August 2015
  Purpose
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: Endpoint Classification: Safety/Efficacy Study
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 German Low Grade Lymphoma Study Group:

Primary Outcome Measures:
  • Overall Remission Rate [ Time Frame: end of therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Median Overall Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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 
Study First Received: August 4, 2009
Last Updated: August 17, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on May 02, 2016