Phase II Study of Decitabine in Acute Myeloid Leukemia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Rate of Complete Remission
研究概览
简要总结
This phase II trial is studying how well decitabine works in treating patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing
详细描述
PRIMARY OBJECTIVES:
I. Determine the rate of complete remission (CR) in patients with previously untreated acute myeloid leukemia treated with decitabine.
SECONDARY OBJECTIVES:
I. Determine the rate of overall survival at 1 year in patients treated with this drug.
II. Determine the overall response rate (CR, incomplete CR, and partial remission) in patients treated with this drug.
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 or cytologically confirmed acute myeloid leukemia (AML) meeting 1 of the following criteria:
- •At least 60 years of age and not a candidate for or refused standard induction treatment
- •Poor risk cytogenetics
- •AML following antecedent hematologic disorder
- •Therapy-related AML
- •Secondary AML
- •No granulocytic sarcoma as sole site of disease
- •No active CNS disease or CNS relapse
- •ECOG performance status 0-2
- •Life expectancy > 6 months
- •Total bilirubin < 2.0 mg/dL
- •Creatinine < 2.0 mg/dL
- •AST and ALT < 2.5 times upper limit of normal
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No NYHA class III or IV congestive heart failure
- •No uncontrolled infection
- •No history of allergic reactions attributed to compounds of similar chemical or biologic composition to decitabine that are not easily managed
- •No other uncontrolled illness including, but not limited to, any of the following:
- •Symptomatic congestive heart failure
- •Unstable angina pectoris
- •Serious cardiac arrhythmia
- •Psychiatric illness or social situations that would preclude compliance with study requirements
- •No active second malignancy involving the blood or marrow or likely to progress and require therapy in the next 6 months
- •No prior therapy for AML except emergency leukapheresis or hydroxyurea for leukocytosis
- •No prior azacitidine or decitabine
- •No prior cytarabine or other conventional chemotherapy agents for antecedent hematologic disorders
- •Prior myeloid growth factors, recombinant erythropoietin, thalidomide, or lenalidomide allowed
- •No concurrent palliative radiotherapy
- •No other concurrent investigational agents
- •No other concurrent direct anti-leukemia therapy
- •No concurrent combination antiretroviral therapy for HIV-positive patients
排除标准
- 未提供
研究组 & 干预措施
Treatment (chemotherapy)
Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: decitabine (Drug)
Treatment (chemotherapy)
Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
Treatment (chemotherapy)
Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: pharmacological study (Other)
Treatment (chemotherapy)
Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: high performance liquid chromatography (Other)
Treatment (chemotherapy)
Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: microarray analysis (Genetic)
Treatment (chemotherapy)
Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: RNA analysis (Genetic)
Treatment (chemotherapy)
Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: mass spectrometry (Other)
Treatment (chemotherapy)
Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: DNA methylation analysis (Genetic)
Treatment (chemotherapy)
Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: matrix-assisted laser desorption/ionization time of flight mass spectrometry (Other)
结局指标
主要结局
Rate of Complete Remission
时间窗: Up to 24 weeks
Per International Working Group criteria: Morphologic complete remission (CRm): Defined as morphologic leukemia-free state, including \<5% blasts in BM aspirate with marrow spicules and a count of \> 200 nucleated cells and no blasts with Auer rods, no persistent extramedullary disease, ANC \> 1000/uL, platelet count \> 100,000/uL. Patient must be independent of transfusions for a minimum of 1 week before each marrow assessment. Morphologic complete remission with incomplete blood count recovery (CRi): Defined as CR with the exception of neutropenia \<1000/uL or thrombocytopenia \<100,000/ul. Complete Remission Rate (CRm + CRi)
次要结局
- Measurement of DNA Methylation in Peripheral Blood or Bone Marrow Cells(From baseline to up to day 28 of course 1)
- Measurement of DNMT Protein in Peripheral Blood or Bone Marrow Cells(Pre treatment)
- Measurement of HbF in Peripheral Blood or Marrow Cells(From baseline to up to days 28 of course 2)
- Measurement of Gene Expression in Peripheral Blood or Bone Marrow(From baseline to up to day 28 of course 1)