EUCTR2010-021961-61-AT进行中（未招募）1 期
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) - VALOR
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 750
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able to understand and provide written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization, as appropriate
- •2. At least 18 years of age
- •3. Diagnosis of acute myeloid leukemia (AML) by World Health Organization (WHO) classification
- •4. First relapsed or refractory AML with at least 5% blasts by bone marrow biopsy or aspirate, or at least 1% blasts in peripheral blood, and meeting the criteria for relapsed or refractory AML detailed in section 4.1 of the protocol
- •5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- •6. Local clinical laboratory values as follows:
- •- Serum creatinine = 2.0 mg/dL
- •- Total bilirubin = 1.5 x the upper limit of normal (ULN), unless due to Gilbert’s syndrome
- •- Aspartate aminotransferase (AST) = 2.5 x ULN
- •- Alanine aminotransferase (ALT) = 2.5 x ULN
- •7. Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)
- •8. Clinically significant nonhematologic toxicity after prior chemotherapy has recovered to grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03
- •9. Females must be surgically or biologically sterile or postmenopausal (amenorrheic for at least 12 months) or if of childbearing potential, must have a negative urine or serum pregnancy test within 14 days before randomization, and must agree to use an adequate method of contraception during the study until 30 days after the last treatment. Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 30 days after the last treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 250
排除标准
- •1. Acute promyelocytic leukemia (APL)
- •2. More than 2 cycles of induction therapy for AML
- •3. Completion of a single cycle of treatment containing a total dose of 5 g/m2 or more of cytarabine within the 90 days before randomization
- •4. Allogeneic or autologous transplant for AML with infusion of stem cells within 90 days before randomization, or on active immunosuppressive therapy for graft-versus-host disease (GVHD) or GVHD prophylaxis within 2 weeks before randomization
- •5. Known or suspected central nervous system (CNS) involvement of active AML
- •6. Other active malignancies (including other hematologic malignancies) or other malignancies within 12 months before randomization, except nonmelanoma skin cancer or cervical intraepithelial neoplasia
- •7. Uncontrolled active infection of any type
- •- Infections under control with antibiotic treatment are acceptable
- •- Chronic hepatitis is acceptable
- •8. Uncontrolled invasive fungal infection (positive blood or tissue culture)
- •9. History of myocardial infarction (MI), unstable angina, cerebrovascular accident, or transient ischemic attack (CVA/TIA) within 3 months before randomization
- •10. Prior or current therapy:
- •- Hydroxyurea or medications to reduce blast count within 24 hours before randomization
- •- Treatment with an investigational product within 14 days before randomization, or not recovered from all acute effects of previously administered investigational products
- •11. Hemodialysis or peritoneal dialysis required
- •12. Prior exposure to vosaroxin
- •13. Pregnant or breastfeeding
- •14. Known HIV seropositivity
- •15. Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the investigator or medical monitor
研究者
相似试验
进行中（未招募）
1 期
Study of vosaroxin or placebo in combination with cytarabine in patients with first relapsed or refractory acute myeloid leukemiaRelapsed or refractory acute myeloid leukemiaMedDRA version: 17.0Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10054296Term: Acute myeloid leukemia NOSSystem Organ Class: 100000004864EUCTR2010-021961-61-CZSunesis Pharmaceuticals, Inc.750
进行中（未招募）
1 期
Study of vosaroxin or placebo in combination with cytarabine in patients with first relapsed or refractory acute myeloid leukemiaRelapsed or refractory acute myeloid leukemiaMedDRA version: 20.0Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10054296Term: Acute myeloid leukemia NOSSystem Organ Class: 100000004864EUCTR2010-021961-61-DESunesis Pharmaceuticals, Inc.750
进行中（未招募）
不适用
Study of vosaroxin or placebo in combination with cytarabine in patients with first relapsed or refractory acute myeloid leukemiaRelapsed or refractory acute myeloid leukemiaMedDRA version: 17.0Level: LLTClassification code 10060558Term: Acute myeloid leukemia recurrentSystem Organ Class: 100000004864MedDRA version: 17.0Level: LLTClassification code 10054296Term: Acute myeloid leukemia NOSSystem Organ Class: 100000004864EUCTR2010-021961-61-HUSunesis Pharmaceuticals, Inc.750
进行中（未招募）
1 期
Study of vosaroxin or placebo in combination with cytarabine in in patients with first relapsed or refractory acute myeloid leukemia.Relapsed or refractory acute myeloid leukemiaMedDRA version: 17.0 Level: LLT Classification code 10060558 Term: Acute myeloid leukemia recurrent System Organ Class: 100000004864MedDRA version: 17.0 Level: LLT Classification code 10054296 Term: Acute myeloid leukemia NOS System Organ Class: 100000004864EUCTR2010-021961-61-GBSunesis Pharmaceuticals, Inc.750
进行中（未招募）
1 期
Study of vosaroxin or placebo in combination with cytarabine in patients with first relapsed or refractory acute myeloid leukemiaEUCTR2010-021961-61-BESunesis Pharmaceuticals, Inc.750