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Omacetaxine for Consolidation and Maintenance

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ClinicalTrials.gov Identifier: NCT01873495
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : September 3, 2018
Sponsor:
Collaborator:
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
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 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). [ Time Frame: 14 days ]
  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 will be obtained before starting maintenance and at 3 and 6 months from the start of maintenance. [ Time Frame: 3 months ]
  4. Toxicities will be monitored by history, physical examination, and laboratory monitoring-during maintenance. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Toxicities will be monitored by history, physical examination, and laboratory monitoring-during consolidation. [ 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 http://ctep.cancer.gov/reporting/ctc.html).



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

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 ClinicalTrials.gov identifier (NCT number): NCT01873495


Locations
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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
Investigators
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Principal Investigator: Martha L. Arellano, MD Emory University

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Responsible Party: Martha Arellano, MD, Emory University
ClinicalTrials.gov Identifier: NCT01873495     History of Changes
Other Study ID Numbers: IRB00057844
Winship2176-11 ( Other Identifier: Other )
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: September 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Leukemia
Neoplasms by Histologic Type
Neoplasms
Homoharringtonine
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action