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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 试验地点
- 15
- 主要终点
- Cytogenetic response (complete and partial)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •18 and over
- •Performance status
- •Life expectancy
- •More than 6 months
- •Hematopoietic
- •See Disease Characteristics
- •Not specified
- •Not specified
- •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
- •At least 4 weeks since prior surgery
- •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
排除标准
- 未提供
结局指标
主要结局
Cytogenetic response (complete and partial)
次要结局
- Survival
- Time to progression
- Toxicity as assessed by the Expanded Common Toxicity Criteria v2.0