Genomic Predictors of Decitabine Response in AML/MDS
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Correlation of Patient Specific Mutations With Overall Response Rate
研究概览
简要总结
This clinical trial studies potential genetic markers which might be used to predict which patients with acute myeloid leukemia or myelodysplastic syndromes respond to decitabine. This study will contribute to the efforts to find effective and less toxic therapies to provide durable remissions in a significant proportion of elderly AML patients.
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
- •All of the following:
- •Patient must have non-M3 AML or MDS
- •An adverse risk karyotype defined by:
- •Complex karyotype by cytogenetics, or
- •Deletion of all or part of chromosome 5, 7, 12, or 17 defined by FISH or cytogenetics, or
- •Somatic TP53 mutation
- •All of the following:
- •Patient must have an ECOG performance status ≤
- •Patient must have >10% disease burden measured by cytomorphology, flow cytometry, or cytogenetics.
- •Patient must have peripheral white blood cell count < 50,000/mcl.
- •Patient must have adequate organ function, defined as:
- •Total bilirubin < 1.5 x ULN
- •AST/ALT < 2.5 x ULN
- •Serum creatinine < 2.0 x ULN
- •Patient must have undergone ≤ 2 cycles of prior hypomethylating agent (decitabine or azacitidine).
- •Patient must be enrolled in HRPO# 201011766 ("Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases").
- •Patient must be > 18 years of age.
- •Patient must be able to understand and willing to sign an IRB-approved written informed consent document.
排除标准
- •Patient must not be pregnant or nursing
- •Patient must not have acute promyelocytic leukemia or t(15;17) observed by FISH.
- •Patient must not have known central nervous system (CNS) leukemia
- •Patient must not have a history of positive human immunodeficiency virus (HIV) serology
- •Patient must not have a history of positive hepatitis C serology
- •Patient must not have undergone prior allogeneic stem cell transplant
- •Patient must not have any uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, ongoing or active graft-versus-host disease (GVHD), congestive heart failure of New York Heart Association (NYHA) class 3 or 4, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
- •Patient must not have had radiation therapy within 14 days of enrollment
- •Patient must not have received any chemotherapy within 21 days of enrollment and any acute treatment-related toxicities must have returned to baseline. Patients may be receiving hydrea at time of enrollment.
研究组 & 干预措施
Decitabine
Patients receive decitabine IV over 1 hour on days 1-10 of a 28-day cycle. Treatment continues for 2 cycles. Patients then receive decitabine IV over 1 hour on days 1-10, 1-5, or 1-3 (depending on response). Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: decitabine (Drug)
结局指标
主要结局
Correlation of Patient Specific Mutations With Overall Response Rate
时间窗: 4 months (4 treatment cycles)
-Best response after 4 treatment cycles as assessed according to International Working Group (IWG) criteria; bone marrow for gene sequencing will be collected at baseline; mutations will be correlated with overall response rate --Complete remission (CR), Complete remission with incomplete hematologic recovery (CRi), Marrow complete remission (mCR), Partial remission (PR), Stable disease (SD), Progressive disease (PD)
次要结局
- Change in Bone Marrow Methylcytosine(Baseline and Day 10)
- Compare Outcomes of a 10-day Decitabine Per Cycle Regimen to a 5-day Regimen (Historical Controls)(4 months (4 treatment cycles))
- Rate of Mutation Clearance During Treatment(Up to Day 56)
- Peripheral Blood Decitabine Plasma Levels(Day 4)