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

August 11, 2014 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A CRC Trial of Rituximab in Combination With Sargramostim (GM-CSF) in Patients With Chronic Lymphocytic Leukemia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall response rate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Ian W. Flinn, MD, PhD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

December 14, 2005

First Submitted That Met QC Criteria

December 14, 2005

First Posted (Estimate)

December 15, 2005

Study Record Updates

Last Update Posted (Estimate)

August 12, 2014

Last Update Submitted That Met QC Criteria

August 11, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J0546 CDR0000450145
  • P30CA006973 (U.S. NIH Grant/Contract)
  • P01CA081534 (U.S. NIH Grant/Contract)
  • JHOC-J0546
  • JHOC-05070103
  • CLLRC-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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