Omacetaxine for Consolidation and Maintenance

Recruitment & Eligibility

Inclusion Criteria

Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria.
Age ≥ 55 years.
Patient eligible for standard induction chemotherapy based on Eastern Cooperative Oncology Group (ECOG) performance status and vital organ function at the discretion of the treating physician.
Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible.
Provide signed written informed consent.
Be able to comply with study procedures and follow-up examinations.
Be non-fertile or agree to use birth control during the study through the end of last treatment visit.
Adequate renal and hepatic function at the time of second registration:
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); and
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and
- Serum creatinine ≤ 1.2 x ULN.
ECOG performance ≤ 2 at the time of second registration.
Patients with a history of carcinoma in remission, on no therapy or on hormonal therapy for the adjuvant treatment of breast carcinoma or prostate carcinoma are included in the study.

Exclusion Criteria

Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t (15;17)(q22;q12), (PML/retinoic acid receptor alpha [RARa] and variants).
Prior treatment with omacetaxine.
Relapsed or refractory AML.
Investigational agent received within 30 days prior to the first dose of study drug. If received any investigational agent prior to this time point, drug-related toxicities must have recovered to Grade 2 or less prior to first dose of study drug.
Psychiatric disorders that would interfere with consent, study participation, or follow-up.
Systemic fungal, bacterial, viral, or other infection not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver, or other organ system that may place the patient at undue risk to undergo the proposed therapy. This includes uncontrolled hypertension and uncontrolled diabetes, as cases of life threatening hyperglycemia have been reported (using continuous infusion at higher doses of omacetaxine).
Active carcinoma requiring systemic chemotherapy or radiation therapy.

Study & Design

Arm && Interventions

Group	Intervention	Description
Omacetaxine: Consolidation/Maintenance	Omacetaxine	-

Primary Outcome Measures

Name	Time	Method
Assessment of Disease Status	1 month	Bone marrow biopsy and aspirate will be obtained.
Disease Status Assessment Prior to Each Consolidation Cycle	14 days	Disease status will be assessed by a bone marrow aspirate and biopsy prior to each of 3 consolidation cycles (to ensure that patients are still in remission).
Bone Marrow Aspirate to Confirm Continuous Remission	3 months	Bone marrow aspirate to confirm continuous remission will be obtained before starting maintenance and at 3 and 6 months from the start of maintenance.
Maintenance Toxicities	24 weeks	Toxicities will be monitored by history, physical examination, and laboratory monitoring during maintenance.

Secondary Outcome Measures

Name	Time	Method
Consolidation Toxicities	12 weeks	Toxicities will be monitored by history, physical examination, and laboratory monitoring (CBC, serum chemistries to include renal and liver function tests) obtained weekly during consolidation and monthly during maintenance according to standard of care (Appendices C and D). Toxicity will be assessed according to the NCI Common Toxicity Criteria Version 4.0 (available at the NCI web site http://ctep.cancer.gov/reporting/ctc.html).

Recruitment & Eligibility