Clinical trial NCT01873495: Omacetaxine for Consolidation and Maintenance
Official title: Omacetaxine for Consolidation and Maintenance in Patients Age ≥ 55 With AML in First Remission: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Myelogenous Leukemia (AML)
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Teva Pharmaceuticals USA
First posted: 2013-06-10
Enrollment: 7
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to assess the safety and tolerability of omacetaxine for consolidation in patients age 55 and older with acute myelogenous leukemia (AML) in first complete remission following induction with cytarabine and an anthracycline, and also to assess the safety and tolerability of omacetaxine for maintenance in patients age 55 and older with acute AML in first complete remission following 3 consolidation courses with omacetaxine.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of AML including de novo, secondary, or with an antecedent hematologic disorder (AHD) according to the World Health Organization (WHO) criteria.
2. Age ≥ 55 years.
3. 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.
4. Patients who received 1-2 cycles of hypomethylating therapy (decitabine azacitidine) are eligible.
5. Provide signed written informed consent.
6. Be able to comply with study procedures and follow-up examinations.
7. Be non-fertile or agree to use birth control during the study through the end of last treatment visit.
8. 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.
9. ECOG performance ≤ 2 at the time of second registration.
10. 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:

1. 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).
2. Prior treatment with omacetaxine.
3. Relapsed or refractory AML.
4. 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.
5. Psychiatric disorders that would interfere with consent, study participation, or follow-up.
6. 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).
7. 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).
8. Active carcinoma requiring systemic chemotherapy or radiation therapy.

Primary outcomes:
measure: Disease Status Assessment Prior to Each Consolidation Cycle
timeFrame: 14 days
measure: Assessment of Disease Status
timeFrame: 1 month
measure: Bone Marrow Aspirate to Confirm Continuous Remission
timeFrame: 3 months
measure: Maintenance Toxicities
timeFrame: 24 weeks
Secondary outcomes:
measure: Consolidation Toxicities
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University
name: Martha L. Arellano, MD
role: PRINCIPAL_INVESTIGATOR
References: