Omacetaxine and Low Dose Cytarabine in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Cephalon
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01272245
First received: January 6, 2011
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

The goal of this clinical research study is to learn if omacetaxine given with cytarabine can help to control the disease in patients with AML or high-risk MDS. The safety of the study drugs will also be studied.


Condition Intervention Phase
Leukemia
Drug: Omacetaxine
Drug: Cytarabine
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Omacetaxine (OM) and Low Dose Cytarabine (LDAC) in Older Patients With Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Complete Remission Rate (CR) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Omacetaxine and Cytarabine
Omacetaxine 1.25 mg/m2 SQ every 12 hours x 3 days + Cytarabine 20 mg SQ x 7 days of 4-7 week cycle.
Drug: Omacetaxine
1.25 mg/m2 subcutaneously (SQ) every 12 hours (+/- 3 hours) for 3 days (Days 1-3). Each cycle will be 4-7 weeks.
Drug: Cytarabine
20 mg subcutaneously every 12 hours (+/- 3 hours) for 7 days (Days 1-7). Each cycle will be 4-7 weeks.
Other Names:
  • ARA-C
  • Cytosar
  • Depo-Cyt
  • Cytosine Arabinosine Hydrochloride

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Previously untreated AML (>/= 20% blasts). 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. 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 >/= 60 years.
  3. ECOG performance status </= 2.
  4. Adequate hepatic (serum total bilirubin </= 1.5 x ULN, 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.

Exclusion Criteria:

  1. 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), 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. Pregnancy.
  5. Acute promyelocytic leukemia (APL).
  6. Women of childbearing potential and men who do not practice contraception. Non-childbearing is defined as >/= 1 year postmenopausal or surgically sterilized.
  7. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01272245

Contacts
Contact: Hagop Kantarjian, MD 713-792-7026

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Hagop Kantarjian, MD         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Cephalon
Investigators
Principal Investigator: Hagop Kantarjian, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01272245     History of Changes
Other Study ID Numbers: 2010-0736, NCI-2013-02220
Study First Received: January 6, 2011
Last Updated: June 30, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Acute Myelogenous Leukemia
AML
High-Risk Myelodysplastic Syndrome
MDS
Omacetaxine
Cytarabine
ARA-C
Cytosar
DepoCyt
Cytosine Arabinosine Hydrochloride

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Cytarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 09, 2014