A Phase II Study of Single Agent Clofarabine in Previously Untreated Older Adult Patients With Acute Myelogenous Leukemia (AML) for Whom Standard Induction Chemotherapy is Unlikely to be of Benefit
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 20
- 主要终点
- Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)
研究概览
简要总结
Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.
This study will evaluate the efficacy of clofarabine in elderly patients with acute myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients with AML.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AML (de novo, secondary or with an antecedent hematologic disorder [AHD])
- •Age ≥ 60 years
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Presence of at least one adverse prognostic factor: Age ≥ 70 years; or AHD; or ECOG performance status of 2; or Intermediate or unfavorable (i.e., adverse) karyotype defined as any cytogenetic profile except the presence of any of the following:
- •t(8;21)(q22;q22)
- •inv(16)(p13;q22 or t(16;16)(p13;q22)
- •t(15;17)(q22;q12) and variants.
- •Adequate renal and hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and Serum creatinine ≤ 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation
- •Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 40% or left ventricular fractional shortening ≥ 22%
排除标准
- •Diagnosis of acute promyelocytic leukemia
- •Prior treatment with clofarabine
- •Prior treatment for AML or an antecedent hematologic disorder
- •Prior hematopoietic stem cell transplant (HSCT)
- •Prior radiation therapy to the pelvis
- •Investigational agent received within 30 days prior to the first dose of study drug
- •Ongoing uncontrolled systemic infection
- •Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in-situ carcinoma or cervical intraepithelial neoplasia regardless of disease-free duration are eligible for this study if definitive treatment for the condition has been completed; Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on PSA value are eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
- •Clinical evidence of central nervous system (CNS) involvement
- •Severe concurrent medical condition or psychiatric disorder that would preclude study participation
- •Positive human immunodeficiency virus (HIV) test
研究组 & 干预措施
Clofarabine
Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
干预措施: clofarabine (Drug)
结局指标
主要结局
Percentage of Participants Achieving Overall Remission (OR) After No More Than Two Cycles (Approximately Month 2)
时间窗: approximately Month 2
Best response was assessed by the Independent Response Review Panel(IRRP) after two cycles of treatment. Overall remission(OR) is the sum of complete remission(CR) and complete remission in the absence of platelet recovery(CRp). CR includes normal values for peripheral blood cell counts (absolute neutrophil and platelet) and leukemic blast cells from bone marrow biopsy or aspirate, and absence of extramedullary disease. Partial remission(PR) includes recovery of peripheral blood cells with improved but still abnormal values in leukemic blast cells.
次要结局
- Kaplan Meier Estimate for Duration of Remission (DOR)(Up to 2 years)
- Kaplan Meier Estimate for Disease-free Survival (DFS)(Up to 2 years)
- Kaplan Meier Estimates for Overall Survival (OS)(Up to 2 years)
- Overall Participant Counts Summarizing Adverse Events (AEs) During the Treatment and Follow-up Periods(Up to 2 years)
- Percentage of Participants Who Died Within Thirty Days of Treatment (30-day Mortality Rate)(up to Day 30)