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Rituximab and GM-CSF in Treat...

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

Last Updated: 2014-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2006-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Leukemia

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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rituximab

Intervention Type BIOLOGICAL

sargramostim

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers