This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been terminated.
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center Identifier:
First received: December 14, 2005
Last updated: August 11, 2014
Last verified: August 2014

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 Intervention Phase
Leukemia Biological: rituximab Biological: sargramostim Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Overall response rate

Study Start Date: July 2005
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
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
  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 identifier: NCT00265915

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Ian W. Flinn, MD, PhD Sidney Kimmel Comprehensive Cancer Center
  More Information Identifier: NCT00265915     History of Changes
Other Study ID Numbers: J0546 CDR0000450145
P01CA081534 ( U.S. NIH Grant/Contract )
P30CA006973 ( U.S. NIH Grant/Contract )
Study First Received: December 14, 2005
Last Updated: August 11, 2014

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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:
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents processed this record on September 19, 2017