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GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
rituximab
sargramostim
gene expression analysis
gene rearrangement analysis
polymerase chain reaction
polymorphism analysis
laboratory biomarker analysis
Sponsored by
French Innovative Leukemia Organisation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring stage II grade 1 follicular lymphoma, stage II grade 2 follicular lymphoma, stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS:

  • Histologically and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification

    • Grade 1-3a disease
    • Stage II-IV disease
    • Non-bulky disease
  • Must have undergone initial nodal biopsy within the past 4 months
  • At least 1 measurable lesion
  • Low tumor-burden, as defined by the following GELF criteria:

    • Nodal or extranodal tumor mass (diameter < 7 cm)
    • No systemic B symptoms
    • No increased LDH and β2 microglobulinemia
    • No substantial splenic enlargement
    • No serous effusion
    • No compression syndrome

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active hepatitis

PRIOR CONCURRENT THERAPY:

  • No prior treatment, including steroids and radiotherapy

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Overall objective tumor response rate at the end of induction therapy

    Secondary Outcome Measures

    Time to progression
    Overall survival
    Duration of response
    Time to next treatment
    Safety profile
    Influence of FcγR polymorphisms on clinical response and survival
    FcγR expression during study treatment
    Molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow as measured by PCR assay

    Full Information

    First Posted
    May 5, 2009
    Last Updated
    August 1, 2013
    Sponsor
    French Innovative Leukemia Organisation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00893477
    Brief Title
    GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma
    Official Title
    An Open Label, Multicenter, Non Randomized Phase II Study to Evaluate Anti-tumor Efficacy and Safety of GM-CSF (Sargramostim, Leukine®) Associated With Rituximab (MabThera®) in Patients With Follicular Non Hodgkin's Lymphoma With no Prior Treatment
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2009 (undefined)
    Primary Completion Date
    March 2011 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    French Innovative Leukemia Organisation

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving GM-CSF together with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying how well giving GM-CSF together with rituximab works in treating patients with previously untreated follicular non-Hodgkin lymphoma.
    Detailed Description
    OBJECTIVES: Primary Evaluate the clinical efficacy of sargramostim (GM-CSF) and rituximab, in terms of overall objective complete and partial response rates, in patients with previously untreated follicular non-Hodgkin lymphoma. Secondary Evaluate the time to progression in patients treated with this regimen. Evaluate the overall survival of patients treated with this regimen. Evaluate the duration of response in patients treated with this regimen. Evaluate the safety profile of this regimen in these patients. Evaluate the influence of FcγR polymorphisms on clinical response. Monitor FcγR-expressing cells in peripheral blood during treatment. Monitor the molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow. OUTLINE: This is a multicenter study. Induction therapy: Patients receive sargramostim (GM-CSF) subcutaneously (SC) on days 1-5 and rituximab IV on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Maintenance therapy: Patients receive GM-CSF SC on days 1-5 and rituximab IV on day 1. Treatment repeats every 8 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity. Blood and bone marrow samples are collected at baseline and periodically during study for analysis of bcl2 rearrangement by PCR assay; FcγR expression by immunophenotyping; and FcγR polymorphisms. After completion of study therapy, patients are followed every 3 months for 1 year and then every 6 months for up to 4 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lymphoma
    Keywords
    stage II grade 1 follicular lymphoma, stage II grade 2 follicular lymphoma, stage II grade 3 follicular lymphoma, stage III grade 1 follicular lymphoma, stage III grade 2 follicular lymphoma, stage III grade 3 follicular lymphoma, stage IV grade 1 follicular lymphoma, stage IV grade 2 follicular lymphoma, stage IV grade 3 follicular lymphoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    rituximab
    Intervention Type
    Biological
    Intervention Name(s)
    sargramostim
    Intervention Type
    Genetic
    Intervention Name(s)
    gene expression analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    gene rearrangement analysis
    Intervention Type
    Genetic
    Intervention Name(s)
    polymerase chain reaction
    Intervention Type
    Genetic
    Intervention Name(s)
    polymorphism analysis
    Intervention Type
    Other
    Intervention Name(s)
    laboratory biomarker analysis
    Primary Outcome Measure Information:
    Title
    Overall objective tumor response rate at the end of induction therapy
    Secondary Outcome Measure Information:
    Title
    Time to progression
    Title
    Overall survival
    Title
    Duration of response
    Title
    Time to next treatment
    Title
    Safety profile
    Title
    Influence of FcγR polymorphisms on clinical response and survival
    Title
    FcγR expression during study treatment
    Title
    Molecular biological marker bcl2 [t(14;18)] in peripheral blood and bone marrow as measured by PCR assay

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Histologically and immunophenotypically confirmed CD20+ follicular lymphoma according to WHO classification Grade 1-3a disease Stage II-IV disease Non-bulky disease Must have undergone initial nodal biopsy within the past 4 months At least 1 measurable lesion Low tumor-burden, as defined by the following GELF criteria: Nodal or extranodal tumor mass (diameter < 7 cm) No systemic B symptoms No increased LDH and β2 microglobulinemia No substantial splenic enlargement No serous effusion No compression syndrome PATIENT CHARACTERISTICS: ECOG performance status 0-1 Negative pregnancy test Fertile patients must use effective contraception No active hepatitis PRIOR CONCURRENT THERAPY: No prior treatment, including steroids and radiotherapy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jean-Francois Rossi, MD, PhD
    Organizational Affiliation
    Hopital Lapeyronie-CHU Montpellier
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    GM-CSF and Rituximab in Treating Patients With Previously Untreated Follicular Non-Hodgkin Lymphoma

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