Study of Vosaroxin and Cytarabine for the Treatment of Adults 60 Years of Age or Older With Previously Untreated AML

NCT02485353 | Terminated Results DMC FDA Drug

• 1 other identifier: IUSCC-0525
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

This is a pilot efficacy assessment clinical trial of vosaroxin and cytarabine for the treatment of adults 60 years of age or older with previously untreated acute myeloid leukemia. A total of 17 evaluable patients are planned to be treated on the study.

Conditions

Leukemia, Myeloid, Acute

Keywords

Vosaroxin; Cytarabine; Remission Induction; Safety; Progression-Free Survival; Mortality Rate; Length of Stay

Outcome Measures

Primary Outcomes (1)

• Rate of Complete Remission

  Percentage of patients who have complete remission as defined by the International Working Group for AML: morphologic complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi or CRp)

  2 months

Secondary Outcomes (1)

• Procedure or Procedure Related Adverse Events

  Up to 1 year

Study Arms (1)

Vosaroxin and Cytarabine

OTHER

Drug: Vosaroxin and Cytarabine

Interventions

Vosaroxin and Cytarabine DRUG

Vosaroxin and Cytarabine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 60 years
• A diagnosis of AML based on WHO classification (\>20% myeloblasts in peripheral blood or bone marrow)
• No previous treatment with chemotherapy for AML, other than hydroxyurea. Previous treatment with hypomethylating agents is acceptable
• Patients must have an ECOG (Zubrod) performance status of 0-2 (see Appendix I).
• Patients must have adequate hepatic function with a total bilirubin \< 1.5 times upper limit normal (ULN) other than cases of Gilbert disease, and ALT and AST \< 2.5 times ULN; and adequate renal function as defined by a serum creatinine \< 2 times ULN.
• Clinically significant nonhematologic toxicity after prior therapy has recovered to grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 or newer
• Patients must have the ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to initiation of treatment
• Left ventricular ejection fraction (LVEF) at least 40% by multiple gated acquisition (MUGA) scan or echocardiogram (ECHO)

You may not qualify if:

• Patients with known central nervous system (CNS) leukemia by spinal fluid cytology, flow cytometry or imaging. A lumbar puncture is not required unless CNS involvement is clinically suspected. Patients with signs or symptoms of leukemic meningitis or a history of leukemic meningitis must have a negative lumbar puncture within 2 weeks of study enrollment.
• A diagnosis of acute promyelocytic leukemia (APL). The study does not require to rule APL out for every subject. However, if there is clinical suspicion for APL, such diagnosis has to be ruled out before initiation of treatment.
• Active malignancy currently undergoing chemo or radiation therapy. Hormone therapy is acceptable.
• Active serious infection that at the discretion of treating physician makes patient ineligible for chemotherapy.

Sponsors & Collaborators

• Hamid Sayar: lead

Study Sites (2)

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

vosaroxin; Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Limitations and Caveats

Due to the death of 2 patients which raised safety concerns, the study was closed with 2 patients enrolled.

Results Point of Contact

• Title: Hamid Sayar, MD
• Organization: IndianaU

ssayar@iu.edu

317-948-7576

Study Officials

• Hamid Sayar, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Clinical Medicine, Hematology/Oncology

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: June 30, 2015
• Study Start: October 20, 2015
• Primary Completion: May 2, 2016
• Study Completion: February 16, 2017
• Last Updated: September 20, 2017
• Results First Posted: September 20, 2017

Record last verified: 2017-08

Locations

US (2)