Sargramostim in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia Who Are Not in Complete Cytogenetic Remission Following Initial Treatment

Study Overview
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Brief Summary
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RATIONALE: Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may bring about complete remission in patients who have chronic phase chronic myelogenous leukemia. PURPOSE: This phase II trial is studying sargramostim to see how well it works in treating patients with chronic phase chronic myelogenous leukemia that is not in complete cytogenetic remission after initial treatment.

Detailed Description
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OBJECTIVES: Determine the efficacy and safety of sargramostim (GM-CSF) by cytogenetic examination of the bone marrow in patients with chronic phase chronic myelogenous leukemia who are not in complete cytogenetic remission after initial therapy. OUTLINE: Patients receive sargramostim (GM-CSF) subcutaneously daily for 3 months in the absence of disease progression or unacceptable toxicity. Patients achieving no response receive GM-CSF for an additional 3 months. Patients failing to achieve a partial response or better after the second course of GM-CSF are removed from the study. Patients achieving a partial response after the first or second course of GM-CSF continue to receive GM-CSF for an additional 9 months. Patients are then re-evaluated. Patients achieving a complete cytologic response at 9 months then receive GM-CSF 3 times weekly in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 weeks. PROJECTED ACCRUAL: A total of 9-24 patients will be accrued for this study within 3 years.

Official Title
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Phase II Study of GM-CSF in Patients With Chronic Phase Chronic Myeloid Leukemia (CP-CML) Who Are Not in Complete Cytogenetic Remission After Initial Therapy

Conditions
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Leukemia

Intervention / Treatment
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* Biological: sargramostim


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed chronic phase chronic myelogenous leukemia (CML) Presence of t(9;22)(q34;q11) with at least 20 cells examined in metaphase by cytogenetic examination of the bone marrow Complete hematologic remission during prior therapy* as seen on 2 separate blood count analyses, defined by the following: WBC no greater than 10,000/mm^3 AND platelet count no greater than 450,000/mm^3 Disappearance of all signs and symptoms of disease, including palpable splenomegaly Normal differential counts (i.e., absence of blasts, promyelocytes, myelocytes, and metamyelocytes) NOTE: *Continuation of therapy that led to complete hematologic remission is required during study participation Persistent cytogenetic disease despite 12 months of prior imatinib mesylate therapy, which may have included a trial dose-escalation OR intolerant of imatinib mesylate at a dose greater than 400 mg/day Not in complete cytogenetic remission within 30 days of study entry Persistent Philadelphia chromosome by bone marrow exam PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 6 months Hematopoietic See Disease Characteristics Hepatic Not specified Renal Not specified Other Not pregnant or nursing Fertile patients must use effective contraception No uncontrolled active infective No serious medical or psychiatric illness that would prevent giving informed consent or limit survival to less than 6 months No other malignancy not in remission except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Prior sargramostim (GM-CSF) allowed Prior interferon alfa for CML allowed No prior stem cell transplantation Concurrent interferon alfa* for CML allowed NOTE: *No dose increase during study participation Chemotherapy At least 4 weeks since prior chemotherapy Endocrine therapy Not specified Radiotherapy At least 4 weeks since prior radiotherapy No concurrent radiotherapy Surgery At least 4 weeks since prior surgery Other Prior imatinib mesylate for CML allowed No other concurrent medication for CML Concurrent imatinib mesylate* for CML allowed NOTE: *No dose increase during study participation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: sargramostim|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytogenetic response (complete and partial) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0 |  |  | 
| Time to progression |  |  | 
| Survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive