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Rituximab and GM-CSF in Treating Patients With Chronic Lymphocytic Leukemia

Primary Purpose

Leukemia

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
rituximab
sargramostim
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Diagnosis of B-cell chronic lymphocytic leukemia meeting 1 of the following criteria: Previously treated stage III or IV or earlier stage disease with evidence of active disease, as defined by ≥ 1 of the following: Weight loss > 10% within the past 6 months Extreme fatigue Fever or night sweats without evidence of infection Worsening anemia or thrombocytopenia Progressive lymphocytosis with a rapid lymphocyte doubling time Marked hypogammaglobulinemia or paraproteinemia Lymphadenopathy > 5 cm in diameter Previously untreated stage 0-II disease with symptoms or significant fatigue or at high risk of progression due to of B2 microglobulin > 3.0 mg/mL Patients who are ≥ 70 years of age with previously untreated stage III or IV or earlier stage disease requiring treatment but who refused chemotherapy are eligible PATIENT CHARACTERISTICS: Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin < 2.0 mg/dL* (elevated bilirubin allowed if due to of Gilbert's disease) NOTE: *Liver dysfunction due to lymphocytic organ infiltration allowed Renal Creatinine < 2.5 mg/dL* NOTE: *Renal dysfunction due to lymphocytic organ infiltration allowed Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active viral infection (e.g., viral hepatitis) PRIOR CONCURRENT THERAPY: Chemotherapy See Disease Characteristics

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Overall response rate

    Secondary Outcome Measures

    Full Information

    First Posted
    December 14, 2005
    Last Updated
    August 11, 2014
    Sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00265915
    Brief Title
    Rituximab and GM-CSF in Treating Patients With Chronic Lymphocytic Leukemia
    Official Title
    A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Terminated
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    Brief Summary
    RATIONALE: 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. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving rituximab together with GM-CSF may be an effective treatment for chronic lymphocytic leukemia. PURPOSE: This phase II trial is studying how well giving rituximab together with GM-CSF works in treating patients with B-cell chronic lymphocytic leukemia.
    Detailed Description
    OBJECTIVES: Determine the complete and overall response rate in patients with B-cell chronic lymphocytic leukemia treated with rituximab and sargramostim (GM-CSF). Determine the time to progression in patients treated with this regimen. Determine the effects of this regimen on CD20 antigen expression and soluble CD20 levels in these patients. OUTLINE: This is a parallel-group, multicenter study. Patients are stratified according to disease status Patients receive rituximab IV on days 4, 11, 18, and 25 and sargramostim (GM-CSF) subcutaneously on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, 40, 43, 45, 47, 50, 52, and 54 (course 1). Patients with responding disease may receive an additional course of treatment. After completion of study treatment, patients are followed periodically for up to 3 years. PROJECTED ACCRUAL: A total of 130 patients will be accrued for this study.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Leukemia
    Keywords
    B-cell chronic lymphocytic leukemia, refractory chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2

    8. Arms, Groups, and Interventions

    Intervention Type
    Biological
    Intervention Name(s)
    rituximab
    Intervention Type
    Biological
    Intervention Name(s)
    sargramostim
    Primary Outcome Measure Information:
    Title
    Overall response rate

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    DISEASE CHARACTERISTICS: Diagnosis of B-cell chronic lymphocytic leukemia meeting 1 of the following criteria: Previously treated stage III or IV or earlier stage disease with evidence of active disease, as defined by ≥ 1 of the following: Weight loss > 10% within the past 6 months Extreme fatigue Fever or night sweats without evidence of infection Worsening anemia or thrombocytopenia Progressive lymphocytosis with a rapid lymphocyte doubling time Marked hypogammaglobulinemia or paraproteinemia Lymphadenopathy > 5 cm in diameter Previously untreated stage 0-II disease with symptoms or significant fatigue or at high risk of progression due to of B2 microglobulin > 3.0 mg/mL Patients who are ≥ 70 years of age with previously untreated stage III or IV or earlier stage disease requiring treatment but who refused chemotherapy are eligible PATIENT CHARACTERISTICS: Performance status Zubrod 0-2 Life expectancy Not specified Hematopoietic See Disease Characteristics Hepatic Bilirubin < 2.0 mg/dL* (elevated bilirubin allowed if due to of Gilbert's disease) NOTE: *Liver dysfunction due to lymphocytic organ infiltration allowed Renal Creatinine < 2.5 mg/dL* NOTE: *Renal dysfunction due to lymphocytic organ infiltration allowed Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active viral infection (e.g., viral hepatitis) PRIOR CONCURRENT THERAPY: Chemotherapy See Disease Characteristics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ian W. Flinn, MD, PhD
    Organizational Affiliation
    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Rituximab and GM-CSF in Treating Patients With Chronic Lymphocytic Leukemia

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