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Omacetaxine for Consolidation and Maintenance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01873495
Recruitment Status : Terminated
First Posted : June 10, 2013
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
Martha Arellano, Emory University

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.

Condition or disease Intervention/treatment Phase
Acute Myelogenous Leukemia (AML) Drug: Omacetaxine Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Omacetaxine for Consolidation and Maintenance in Patients Age ≥ 55 With AML in First Remission: A Pilot Study
Study Start Date : May 2013
Actual Primary Completion Date : July 2018
Actual Study Completion Date : July 2018

Arm Intervention/treatment
Experimental: Omacetaxine: Consolidation/Maintenance Drug: Omacetaxine

Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles.

Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles

Other Name: Synribo

Primary Outcome Measures :
  1. Disease Status Assessment Prior to Each Consolidation Cycle [ Time Frame: 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).

  2. Assessment of Disease Status [ Time Frame: 1 month ]
    Bone marrow biopsy and aspirate will be obtained.

  3. Bone Marrow Aspirate to Confirm Continuous Remission [ Time Frame: 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.

  4. Maintenance Toxicities [ Time Frame: 24 weeks ]
    Toxicities will be monitored by history, physical examination, and laboratory monitoring during maintenance.

Secondary Outcome Measures :
  1. Consolidation Toxicities [ Time Frame: 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01873495

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United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Teva Pharmaceuticals USA
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Principal Investigator: Martha L. Arellano, MD Emory University
  Study Documents (Full-Text)

Documents provided by Martha Arellano, Emory University:
Informed Consent Form  [PDF] March 30, 2017

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Responsible Party: Martha Arellano, MD, Emory University Identifier: NCT01873495    
Other Study ID Numbers: IRB00057844
Winship2176-11 ( Other Identifier: Other )
First Posted: June 10, 2013    Key Record Dates
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action