Study of vosaroxin or placebo in combination with cytarabine in patients with first relapsed or refractory acute myeloid leukemia
- Conditions
- Relapsed 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: 100000004864Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2010-021961-61-BE
- Lead Sponsor
- Sunesis Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 750
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method