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临床试验/NCT02873338
NCT02873338已完成2 期

A Randomized, Phase II Study of CX-01 Combined With Standard Induction Therapy for Newly Diagnosed Acute Myeloid Leukemia

Chimerix23 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2016年8月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
Chimerix
入组人数
75
试验地点
23
主要终点
Number of Subjects Who Achieved Morphologic 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 was an exploratory Phase 2, open label, randomized, multicenter, parallel group study to determine whether there was evidence that the addition of dociparstat (CX-01) at 2 different does levels to standard induction therapy (cytarabine+idarubicin, "7+3") and consolidation therapy had an additive therapeutic effect for subjects newly diagnosed with acute myeloid leukemia (AML) when compared with subjects receiving standard induction chemotherapy alone.

详细描述

The primary efficacy endpoint was to assess whether dociparstat in conjunction with standard induction therapy for AML increased the complete remission rate based on the International Working Group AML response criteria.

A total of 75 subjects were to be randomized in a 1:1:1 ratio to 1 of the following treatment groups:

  • Group 1: cytarabine + idarubicin
  • Group 2: cytarabine + idarubicin + dociparstat 0.125 mg/kg/hr
  • Group 3: cytarabine + idarubicin + dociparstat 0.25 mg/kg/hr

Subjects received up to 2 induction cycles and up to 2 consolidation cycles and participated in the study for up to 18 months. Clinical laboratory tests were conducted routinely, and bone marrow aspirates and biopsies were performed during the induction cycles. Safety was monitored through adverse events and clinical laboratory results.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • •Subjects had to meet all the following criteria to be eligible for enrollment in this study:
  • •Had newly diagnosed, de novo or secondary, previously untreated acute myeloid leukemia (AML).
  • •Had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

排除标准

  • •Subjects who met any of the following criteria were not eligible for enrollment in this study:
  • •Had acute promyelocytic leukemia
  • •Had prior chemotherapy for AML.
  • •Had prior intensive chemotherapy or stem cell transplantation for the treatment of myelodysplastic syndrome.
  • •Had central nervous system (CNS) leukemia.

研究组 & 干预措施

Control (idarubicin+cytarabine)

Active Comparator

Induction:

  • Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

  • Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

干预措施: Idarubicin (Drug)

Control (idarubicin+cytarabine)

Active Comparator

Induction:

  • Idarubicin 12 mg/m2/day by slow (10 to 30 minutes) intravenous (IV) injection/infusion daily (Days 1, 2, and 3)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

  • Idarubicin 12 mg/m2/day slow (10 to 30 minutes) IV injection/infusion daily (Days 1 and 2)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

• Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

干预措施: Cytarabine (Drug)

Dociparstat 0.125 mg/kg

Experimental

Induction:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
  • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

干预措施: Dociparstat sodium (Drug)

Dociparstat 0.125 mg/kg

Experimental

Induction:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
  • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

干预措施: Idarubicin (Drug)

Dociparstat 0.125 mg/kg

Experimental

Induction:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.125 mg/kg/hr continuous 24-hour IV infusion on (Days 1 to 5; total 120 hours)
  • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

干预措施: Cytarabine (Drug)

Dociparstat 0.25 mg/kg

Experimental

Induction:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

  • Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
  • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

干预措施: Dociparstat sodium (Drug)

Dociparstat 0.25 mg/kg

Experimental

Induction:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

  • Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
  • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

干预措施: Idarubicin (Drug)

Dociparstat 0.25 mg/kg

Experimental

Induction:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour intravenous (IV) infusion (Days 1 to 7)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1, 2, and 3)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 7)

Re-induction:

  • Dociparstat 4 mg/kg initial bolus 20 minutes post-idarubicin dose (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5)
  • Idarubicin 12 mg/m2/day slow IV injection/infusion daily (Days 1 and 2)
  • Cytarabine 100 mg/m2/day continuous 24-hour IV infusion (Days 1 to 5)

Consolidation:

  • Dociparstat 4 mg/kg initial bolus 30 minutes post-3-hour cytarabine infusion (Day 1), followed by dociparstat 0.25 mg/kg/hr continuous 24-hour IV infusion (Days 1 to 5; total 120 hours)
  • Cytarabine 1.0 g/m2 over 3 hours, every 12 hours (Days 1, 3, and 5)

干预措施: Cytarabine (Drug)

结局指标

主要结局

Number of Subjects Who Achieved Morphologic Complete Remission

时间窗: During induction and re-induction phases of treatment (up to 60 days after the start of each treatment cycle)

Morphologic complete remission (CR) was evaluated by International Working Group (IWG) criteria and defined as absolute neutrophil count (ANC) \>1000/microliter; platelet count \>100,000, \<5% blasts in bone marrow aspirate, no blasts with Auer rods, and no evidence of extramedullary disease.

次要结局

  • Duration of Event-free Survival(Randomization up to 30 months)
  • Time to Leukemia-free Survival(Randomization until disease relapse or patient death from any cause, whichever occurs first, assessed up to 30 months)
  • Number of Subjects Who Achieved Overall Survival(Randomization to end of study (18 months))
  • Number of Subjects Who Achieved Composite Complete Remission(Up to 60 days after the start of each treatment cycle)
  • Time to Recovery of Neutrophils(Randomization to ANC recovery, for up to 60 days after the start of each treatment cycle)
  • Duration of Morphologic Complete Remission(Randomization to end of study (18 months))
  • Time to Platelet Recovery(Randomization to platelet recovery, for up to 60 days after the start of each treatment cycle)
  • Number of Subjects Who Died by Day 30(30 days (from first day of induction treatment to 30 days after))
  • Number of Subjects Who Died by Day 60.(60 days (from the first day of induction treatment to 60 days after))
  • Number of Subjects Who Died by Day 90(90 days (from the first day of induction treatment to 90 days after))

研究者

发起方
Chimerix
申办方类型
Industry
责任方
Sponsor

研究点 (23)

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