Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

• Status: Terminated
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies the side effects and how well omacetaxine mepesuccinate, cytarabine, and decitabine work in treating older patients with newly diagnosed acute myeloid leukemia. Omacetaxine mepesuccinate, cytarabine, and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Roswell Park Cancer Institute
• Collaborators: National Cancer Institute (NCI); Teva Pharmaceutical Industries, Ltd.
• Treatments: Azacitidine; Cytarabine; Decitabine; Harringtonines; Homoharringtonine

Criteria

Inclusion Criteria:

• Patients who are not eligible for standard induction chemotherapy (or any standard therapy known to be life prolonging) because of poor performance status, significant tissue comorbidities, or unfavorable risk of disease

• Have an unequivocal histologic diagnosis of acute myeloid leukemia (AML) (including secondary AML)

• No prior therapy for AML except hydroxyurea to control counts

• Must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation

• Subject or legal representative must understand the investigational nature of this study and sign an independent ethics committee/institutional review board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

• Subjects with the diagnosis of acute promyelocytic leukemia (t[15;17])

• Unwilling or unable to follow protocol requirements

• Any condition which in the investigator's opinion deems the subject an unsuitable candidate to receive study drug

• Patients with sickle cell disease and sickle cell crisis

• Received an investigational agent for another disease within 30 days prior to enrollment

• The patient has an uncontrolled and active infection that would preclude study conduct and assessment