临床试验/NCT02485353

NCT02485353终止不适用

Pilot Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML

Hamid Sayar2 个研究点分布在 1 个国家目标入组 2 人开始时间: 2015年10月20日最近更新: 2017年9月20日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方
入组人数: 2
试验地点: 2
主要终点: Rate of Complete Remission

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the treatment of adults 60 years of age or older with previously untreated acute myeloid leukemia. A total of 17 evaluable patients are planned to be treated on the study.

详细描述

Primary objective: rate of complete remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) Secondary objectives: (1) safety of this combination in induction therapy of older patients previously unexposed to intensive chemotherapy; (2) progression-free survival; (3) length of stay in hospital for induction; (4) 30- and 60-day mortality rate.

The treatment period will include up to 4 cycles of treatment (induction 1, induction 2, consolidation 1, and consolidation 2). In each cycle, the first day of study treatment will be considered day 1.

Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L.
Up to 2 cycles of consolidation treatment may be completed by eligible patients in remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) if safety parameters are met.

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

•Age > 60 years
•A diagnosis of AML based on WHO classification (>20% myeloblasts in peripheral blood or bone marrow)
•No previous treatment with chemotherapy for AML, other than hydroxyurea. Previous treatment with hypomethylating agents is acceptable
•Patients must have an ECOG (Zubrod) performance status of 0-2 (see Appendix I).
•Patients must have adequate hepatic function with a total bilirubin < 1.5 times upper limit normal (ULN) other than cases of Gilbert disease, and ALT and AST < 2.5 times ULN; and adequate renal function as defined by a serum creatinine < 2 times ULN.
•Clinically significant nonhematologic toxicity after prior therapy has recovered to grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or newer
•Patients must have the ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to initiation of treatment
•Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)

排除标准

•Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Patients with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment.
•A diagnosis of acute promyelocytic leukemia (APL). The study does not require to rule APL out for every subject. However, if there is clinical suspicion for APL, such diagnosis has to be ruled out before initiation of treatment.
•Active malignancy currently undergoing chemo or radiation therapy. Hormone therapy is acceptable.
•Active serious infection that at the discretion of treating physician makes patient ineligible for chemotherapy.

研究组 & 干预措施

Vosaroxin and Cytarabine

Other

干预措施: Vosaroxin and Cytarabine (Drug)

结局指标

主要结局

Rate of Complete Remission

时间窗: 2 months

Percentage of patients who have complete remission as defined by the International Working Group for AML: morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi or CRp)

次要结局

Procedure or Procedure Related Adverse Events(Up to 1 year)

研究者

发起方

Hamid Sayar

申办方类型

Other

责任方

Sponsor Investigator

主要研究者

Hamid Sayar

Assistant Professor of Clinical Medicine, Hematology/Oncology

Indiana University School of Medicine

研究点 (2)

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