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Trial record 8 of 201 for:    "Leukemia" | "Sargramostim"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00265915
Recruitment Status : Terminated
First Posted : December 15, 2005
Last Update Posted : August 12, 2014
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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.

Condition or disease Intervention/treatment Phase
Leukemia Biological: rituximab Biological: sargramostim Phase 2

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia
Study Start Date : July 2005
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Primary Outcome Measures :
  1. Overall response rate

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified


  • See Disease Characteristics


  • Bilirubin < 2.0 mg/dL* (elevated bilirubin allowed if due to of Gilbert's disease) NOTE: *Liver dysfunction due to lymphocytic organ infiltration allowed


  • Creatinine < 2.5 mg/dL* NOTE: *Renal dysfunction due to lymphocytic organ infiltration allowed


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No active viral infection (e.g., viral hepatitis)



  • See Disease Characteristics

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 identifier (NCT number): NCT00265915

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
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Study Chair: Ian W. Flinn, MD, PhD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Layout table for additonal information Identifier: NCT00265915     History of Changes
Other Study ID Numbers: J0546 CDR0000450145
P01CA081534 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
First Posted: December 15, 2005    Key Record Dates
Last Update Posted: August 12, 2014
Last Verified: August 2014
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
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
Additional relevant MeSH terms:
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Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents