Status:
TERMINATED
Omacetaxine for Consolidation and Maintenance
Lead Sponsor:
Emory University
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Acute Myelogenous Leukemia (AML)
Eligibility:
All Genders
55+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01873495
Start Date
May 1 2013
End Date
July 1 2018
Last Update
September 24 2019
Active Locations (1)
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1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322