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

Leukemia, Myeloid, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02485353
• Other study ID #: IUSCC-0525
• Status: Terminated
• Phase: N/A
• First received: June 26, 2015
• Last updated: August 24, 2017
• Start date: October 20, 2015
• Est. completion date: February 16, 2017

Study information

• Verified date: August 2017
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Primary objective: rate of complete remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) Secondary objectives: (1) safety of this combination in induction therapy of older patients previously unexposed to intensive chemotherapy; (2) progression-free survival; (3) length of stay in hospital for induction; (4) 30- and 60-day mortality rate.

The treatment period will include up to 4 cycles of treatment (induction 1, induction 2, consolidation 1, and consolidation 2). In each cycle, the first day of study treatment will be considered day 1.

• Each cycle will include vosaroxin treatment on days 1 and 4 (total of 2 days) and cytarabine treatment on days 1-5 (total of 5 days) followed by a variable interval required to achieve hematologic recovery, defined as absolute neutrophil count (ANC) > 1000 cells/L.

• Up to 2 cycles of consolidation treatment may be completed by eligible patients in remission (morphologic complete remission or morphologic complete remission with incomplete blood count recovery) if safety parameters are met.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: February 16, 2017
• Est. primary completion date: May 2, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Vosaroxin and Cytarabine

Locations

Country	Name	City	State
United States	Indiana University Health Hospital	Indianapolis	Indiana
United States	Indiana University Health Melvin and Bren Simon Cancer Center	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Hamid Sayar

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedure or Procedure Related Adverse Events	Number of unique patients who had a procedure or treatment related (possible, probable or definite) adverse events. (graded per NCI CTC v4.0)	Up to 1 year