Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 61
Summary
- Conditions
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
- Acute Myeloid Leukemia With Multilineage Dysplasia
- Myeloid Sarcoma
- Secondary Acute Myeloid Leukemia
- Therapy-Related Acute Myeloid Leukemia
- Therapy-Related Myelodysplastic Syndrome
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. To assess the rate of complete remission (CR) after induction therapy with the combination of "7+V" (vosaroxin and standard dose infusional cytosine arabinoside [ara-C]) for patients with newly diagnosed, previously untreated acute myelogenous leukemia (AML). SECONDARY OBJECTI...
PRIMARY OBJECTIVES: I. To assess the rate of complete remission (CR) after induction therapy with the combination of "7+V" (vosaroxin and standard dose infusional cytosine arabinoside [ara-C]) for patients with newly diagnosed, previously untreated acute myelogenous leukemia (AML). SECONDARY OBJECTIVES: I. Frequency of grade 3-5 adverse events related to administration of "7+V". II. To evaluate for the presence of minimal residual disease (MRD) remaining after "7+V" induction and/or re-induction. III. To determine the CR/CR with incomplete blood count recovery (CRi) rate after one and/or 2 cycles of "7+V" induction. IV. To determine the time to neutrophil and platelet recovery following "7+V" induction. V. To assess disease-free survival (DFS) at 1 year (yr) of patients achieving CR/CRi after "7+V" induction. VI. To assess overall survival (OS) at 1 yr of all patients receiving protocol-defined therapy. VII. To determine the correlation of hematopoietic stem cell transplant (HSCT) comorbidity index and Wheatley Index scores with disease response, DFS and OS. TERTIARY OBJECTIVES: I. To describe the mutational burden of this cohort of AML patients. II. To correlate genomic aberration with response rate, DFS, and OS. III. To determine the number of patients treated with vosaroxin who eventually go to allogeneic HSCT. OUTLINE: Patients receive vosaroxin intravenously (IV) on days 1 and 4 and cytarabine IV continuously on days 1-7 (Induction-I). Patients with residual leukemia and for whom a second course is indicated in the judgment of the investigator may undergo a second course of treatment (Induction-II) 14-57 days after day 1 of Induction-1 After completion of study treatment, patients are followed every 3 months for 1 year.
Tracking Information
- NCT #
- NCT02658487
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Stephen Strickland, MD Vanderbilt-Ingram Cancer Center Principal Investigator: Michael Savona, MD Vanderbilt-Ingram Cancer Center
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