Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Completed 18 and over NCI, Pharmaceutical / Industry CCCWFU-23102 BRLX-02153, NCT00072579, NCI-7350, 7350

Objectives

1. 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.

Entry Criteria

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/mm³ AND platelet count no greater than 450,000/mm³
  • 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

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]

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

Expected Enrollment

A total of 9-24 patients will be accrued for this study within 3 years.

Outcomes

Cytogenetic response (complete and partial)

Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0
Time to progression
Survival

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.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Istvan Molnar, MD, Protocol chair		Ph: 336-716-5847; 800-446-2255
Bayard Powell, MD, Protocol co-chair		Ph: 336-716-7970; 800-446-2255 Email: bpowell@wfubmc.edu

Registry Information
Official Title		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
Trial Start Date		2003-09-19
Registered in ClinicalTrials.gov		NCT00072579
Date Submitted to PDQ		2003-09-10
Information Last Verified		2006-03-13
NCI Grant/Contract Number		CA12197, CA81851

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