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Omacetaxine and Decitabine in Acute Myelogenous Leukemia (AML) and Myelodysplastic Syndrome (MDS)

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.
 
ClinicalTrials.gov Identifier: NCT02141477
Recruitment Status : Terminated (Slow Accrual-2 patients were registered Phase I and none in Phase II)
First Posted : May 19, 2014
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Teva Pharmaceuticals USA
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
This clinical research study is made up of 2 phases. The goal of Phase 1 of the study is to test the safety of the combination of omacetaxine and decitabine and to find the best dose to give to future patients. The goal of Phase 2 of the study is to learn if this dose can help to control AML and/or MDS. The safety will then continue to be studied.

Condition or disease Intervention/treatment Phase
Leukemia Drug: Omacetaxine Drug: Decitabine Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Omacetaxine (OM) and Decitabine (DAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
Actual Study Start Date : May 6, 2015
Actual Primary Completion Date : June 22, 2017
Actual Study Completion Date : June 22, 2017


Arm Intervention/treatment
Experimental: Omacetaxine + Decitabine

Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle.

Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle.

Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I.

Drug: Omacetaxine
Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle.
Other Names:
  • Synribo
  • Homoharringtonine

Drug: Decitabine

Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle.

Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I.

Other Name: Dacogen




Primary Outcome Measures :
  1. Safe Dose Combination of Omacetaxine (OM) and Decitabine (DAC) [ Time Frame: 28 days ]
    Safe dose defined as highest dose level with </= 1 out of 6 patients experience a dose limiting toxicity (DLT) during first treatment cycle. DLT defined as clinically significant Grade 3 or 4 adverse event or abnormal laboratory value according to Common Toxicity Criteria for Adverse Effects (CTCAE) criteria assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study.


Secondary Outcome Measures :
  1. Complete Response Rate (CRR) [ Time Frame: 8 weeks ]
    Complete response rate (CRR) is defined as CR or CR with incomplete platelet recovery (CRp).



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously untreated AML (>/= 20% blasts) or AML M6. Patients with high-risk (intermediate-2 or high by IPSS or >/= 10% blasts) MDS will also be eligible. Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed. No prior chemotherapy is allowed except for a single or a two day dose of cytarabine (up to 3 g/m2) for emergency use is also allowed as prior therapy.
  2. Age >/= 70 years.
  3. Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
  4. Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or SGOT </= 2.5 x ULN) and renal function (creatinine </= 2.0 mg/dL).
  5. Patients must be willing and able to review, understand, and provide written consent before starting therapy.
  6. Men of childbearing potential who agree to use contraception prior to study entry and for the duration of participation.

Exclusion Criteria:

  1. New York Heart Association (NYHA) class III or IV heart disease, active ischemia or any other uncontrolled cardiac condition such as angina pectoris, clinically significant cardiac arrhythmia and requiring therapy, uncontrolled hypertension (blood pressure >/= 160 systolic and >/= 110 diastolic not responsive to antihypertensive medication), uncontrolled diabetes mellitus, or congestive heart failure.
  2. Myocardial infarction in the previous 12 weeks (from the start of treatment).
  3. Active and uncontrolled disease/infection as judged by the treating physician.
  4. Acute promyelocytic leukemia (APL).

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): NCT02141477


Locations
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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Teva Pharmaceuticals USA
Investigators
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Principal Investigator: Elias Jabbour, MD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02141477    
Other Study ID Numbers: 2013-0812
NCI-2014-02157 ( Registry Identifier: NCI CTRP )
First Posted: May 19, 2014    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by M.D. Anderson Cancer Center:
Leukemia
Acute Myelogenous Leukemia
AML
High Risk Myelodysplastic Syndrome
MDS
Omacetaxine
Synribo
Homoharringtonine
Decitabine
Dacogen
Additional relevant MeSH terms:
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Leukemia
Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Decitabine
Homoharringtonine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors
Antineoplastic Agents, Phytogenic
Protein Synthesis Inhibitors