Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: vosaroxin + cytarabine; placebo + cytarabine
Intervention description: Vosaroxin days 1 and 4: 90 mg/m2 for induction 1; 70 mg/m2 for all other cycles
Cytarabine 1 g/m2 daily on days 1-5 (IDAC); Placebo days 1 and 4: volume matched to vosaroxin
Cytarabine 1 g/m2 daily on days 1-5 (IDAC)
Intervention MeSH terms: Cytarabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 711.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Acute Myeloid Leukemia; Hematologic; Hematologic diseases; Blood; Cancer; Malignancy; Vosaroxin; Cytarabine; First Relapsed AML; Refractory AML; VALOR; Sunesis; Voreloxin; SNS-595

Summary:

      This study compared treatment groups of patients treated with vosaroxin and cytarabine versus
      patients treated with placebo and cytarabine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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