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

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00265915
First received: December 14, 2005
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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 [ Designated as safety issue: No ]

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:

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.

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00265915

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Ian W. Flinn, MD, PhD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00265915     History of Changes
Other Study ID Numbers: J0546 CDR0000450145, P01CA081534, P30CA006973, JHOC-J0546, JHOC-05070103, CLLRC-008
Study First Received: December 14, 2005
Last Updated: August 11, 2014
Health Authority: United States: Federal Government

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
Leukemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Rituximab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 16, 2014