A Phase 2 Study of Depsipeptide in Patients With Relapsed or Refractory AML
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Response rate (complete and partial)
研究概览
简要总结
This phase II trial is studying how well romidepsin works in treating patients with relapsed or refractory acute myeloid leukemia. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die.
详细描述
PRIMARY OBJECTIVES:
I. Determine the complete and partial response rate in patients with relapsed or refractory acute myeloid leukemia treated with FR901228 (depsipeptide).
II. Determine the toxicity of this drug in these patients. III. Correlate clinical response with specific cytogenetic abnormalities in patients treated with this drug.
OUTLINE: Patients are stratified according to the presence of a specific chromosomal abnormality (t[8;21] vs inv 16 vs t[15;17] vs absence of these chromosomal abnormalities).
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed acute myeloid leukemia (AML) defined by the WHO classification
- •Initial diagnosis with either of the following:
- •Bone marrow or peripheral blood myeloblasts of at least 20%,
- •Recurring genetic abnormalities (e.g., t[8;21], inv 16, or t[16;16]) and
- •Bone marrow blast percentage less than 20%
- •Relapsed or refractory disease defined by 1 of the following:
- •Under 60 years of age and in second relapse or greater,
- •Over 60 years of age and in first relapse,
- •Acute promyelocytic leukemia that has relapsed despite prior tretinoin and arsenic therapy,
- •Primary refractory AML for which no standard therapy exists
- •Patients who are over 60 years of age with previously untreated disease and who refuse conventional chemotherapy are eligible
- •Patients who are over 60 years of age and in first relapse and poor medical candidates for reinduction chemotherapy or who refuse conventional chemotherapy are eligible
- •Not medically appropriate for OR refused curative bone marrow or stem cell transplantation
- •No CNS leukemia
- •ECOG 0-2 OR Karnofsky 60-100%
- •LVEF at least 40% by MUGA
- •QTc interval less than 500 msec by EKG
- •No myocardial infarction within the past 3 months
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No prior allergic reactions attributed to compounds of similar chemical or biological composition to FR901228 (depsipeptide)
- •No concurrent uncontrolled illness
- •No psychiatric illness or social situation that would preclude study compliance
- •No ongoing or active infection
- •At least 4 weeks since prior autologous stem cell or bone marrow transplantation
- •No prior allogeneic stem cell or bone marrow transplantation
- •No concurrent biologic agents
- •At least 2 weeks since prior chemotherapy (6 weeks for mitomycin and nitrosoureas)
- •No concurrent chemotherapy, concurrent hydroxyurea allowed during the first course of study therapy to control hyperleukocytosis
- •No concurrent radiotherapy
- •Recovered from prior therapy
- •At least 4 weeks since prior investigational agents
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent investigational agents
- •No concurrent drugs known to have histone deacetylase inhibitor activity (e.g., sodium valproate)
- •No other concurrent antineoplastic agents
- •No prior FR901228 (depsipeptide)
- •At least 2 weeks since prior radiotherapy
排除标准
- 未提供
研究组 & 干预措施
Treatment
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: romidepsin (Drug)
结局指标
主要结局
Response rate (complete and partial)
时间窗: Up to 7 years
Adverse events, measured using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0
时间窗: Up to 7 years
次要结局
未报告次要终点