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Omacetaxine for Consolidation and Maintenance in Patients Age 60 and Older With AML in First Remission: a Pilot Study

Phase 1/Phase 2
60 Years
Open (Enrolling)
Acute Myelogenous Leukemia (AML)

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Trial Information

Omacetaxine for Consolidation and Maintenance in Patients Age 60 and Older With AML in First Remission: a Pilot Study

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[26] in CR1
after induction chemotherapy

2. Age > 60 years.

3. Provide signed written informed consent.

4. Be able to comply with study procedures and follow-up examinations.

5. Be non-fertile or agree to use birth control during the study through the end of last
treatment visit.

6. Adequate renal and hepatic function:

1. Total bilirubin < 1.5 x institutional Upper Limit of Normal (ULN); and

2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 x ULN;

3. Serum creatinine < 1.2 times the upper limit of normal.

7. ECOG performance < 2

8. 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.

9. Any cytotoxic chemotherapy to treat carcinoma or major surgery must have concluded
within > 4 weeks of enrollment onto this study.


Exclusion Criteria:

1. Age <60

2. Patient not in CR after induction chemotherapy

3. Prior treatment with omacetaxine

4. Relapsed or refractory AML.

5. 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.

6. Psychiatric disorders that would interfere with consent, study participation, or

7. 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).

8. 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.

9. No social support and inability to self-administer subcutaneous injections.

10. Active carcinoma requiring systemic chemotherapy or radiation therapy.


Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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)

Outcome Time Frame:

14 days

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2013

Completion Date:

May 2015

Related Keywords:

  • Acute Myelogenous Leukemia (AML)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Emory University Winship Cancer Institute Atlanta, Georgia  30322