A Phase 3, Randomized, Controlled, Double-Blind, Multinational Clinical Study of the Efficacy and Safety of Vosaroxin and Cytarabine Versus Placebo and Cytarabine in Patients With First Relapsed or Refractory Acute Myeloid Leukemia (VALOR)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 711
- 试验地点
- 124
- 主要终点
- Overall Survival
研究概览
简要总结
This study compared treatment groups of patients treated with vosaroxin and cytarabine versus patients treated with placebo and cytarabine.
详细描述
The study includes additional objectives to ones listed above as Outcome Measures. These additional objectives also compared treatment groups in the following:
CR + CRp rate, defined as CR + CRp based on modified IWG response criteria.
Combined CR rate (CR+CRp+CRi).
Percentage of patients who have post-treatment (subsequent) transplantation.
Percentage of patients who received subsequent non-protocol therapy (including transplantation).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Provided signed, written informed consent
- •At least 18 years of age
- •Had a diagnosis of AML according to World Health Organization (WHO) classification
- •First relapsed or refractory AML (refractory to initial induction therapy) with at least 5% blasts by bone marrow or aspirate or 1% blasts in peripheral blood with additional requirements for relapsed or refractory
- •Had an ECOG score of 0-2
- •Had adequate liver and renal function as indicated by certain laboratory values
- •Had adequate cardiac function (left ventricular ejection fraction at least 40% by multiple gated acquisition scan or ECG)
- •Nonfertile or agreed to use an adequate method of contraception until 30 days after the last treatment
- •Had any clinically significant nonhematologic toxicity after prior chemotherapy recovered to Grade 1 per NCI-CTCAE
排除标准
- •Had acute promyelocytic leukemia
- •Had more than 2 cycles of induction therapy for AML
- •Had completed a single cycle of treatment containing a total dose of 5 g/m2 or more of cytarabine within 90 days before randomization
- •Refractory to or relapsed within the previous 3 months after therapy with an IDAC- or HIDAC-containing regimen
- •Had received a hematopoietic stem cell transplant (HSCT) within the previous 90 days
- •Had received active immunosuppressive therapy for graft-versus-host disease (GVHD) within 2 weeks before study start
- •Had any other severe concurrent disease, or have a history of serious disease involving the heart, kidney, liver, or other organ system
- •Had evidence of central nervous system involvement of active AML
- •Had other active malignancies (including other hematologic malignancies) or been diagnosed with other malignancies within the last 12 months, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
- •Had an active, uncontrolled infection
- •Had received any other investigational therapy within 14 days or not recovered from acute affects of the other investigational therapy
- •Had received prior or current hydroxyurea or medications to reduce blast count within 24 hours before randomization
- •Had received previous treatment with vosaroxin
- •Pregnant or lactating
- •Had any other medical, psychological, or social condition that may interfere with consent, study participation, or follow-up
- •Had known HIV seropositivity
研究组 & 干预措施
Group A: vosaroxin + cytarabine
vosaroxin (short IV infusion within 10 minutes) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation
干预措施: vosaroxin + cytarabine (Drug)
Group B: placebo + cytarabine
placebo (short IV infusion within 10 minutes and volume matched to vosaroxin) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation
干预措施: placebo + cytarabine (Drug)
结局指标
主要结局
Overall Survival
时间窗: Up to 5 years or duration of study
Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
次要结局
- All Cause Mortality(60 Days)
- Complete Remission (CR) Rate Based on Modified International Working Group (IWG) Criteria.(Up to 5 years or duration of study)