Clinical Trials Directory

Trials / Completed

CompletedNCT02658487

Vosaroxin and Infusional Cytarabine in Treating Patients With Untreated Acute Myeloid Leukemia

Phase II Trial of Vosaroxin in Combination With Infusional Cytarabine in Patients With Untreated AML

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Vanderbilt-Ingram Cancer Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well vosaroxin and cytarabine work in treating patients with untreated acute myeloid leukemia. Drugs used in chemotherapy, such as vosaroxin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed 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 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.

Conditions

Interventions

TypeNameDescription
DRUGCytarabineGiven IV
DRUGVosaroxinGiven IV

Timeline

Start date
2016-03-01
Primary completion
2019-04-01
Completion
2024-09-01
First posted
2016-01-18
Last updated
2025-04-15
Results posted
2020-06-09

Locations

3 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT02658487. Inclusion in this directory is not an endorsement.