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

NCT01272245 | Completed Phase 2 Results

• 2 other identifiers: 2010-0736NCI-2013-02220
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Leukemia

Keywords

Acute Myelogenous Leukemia; AML; High-Risk Myelodysplastic Syndrome; MDS; Omacetaxine; Cytarabine; ARA-C; Cytosar; DepoCyt; Cytosine Arabinosine Hydrochloride

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Remission (CR)

  Complete response (CR) defined as: Peripheral blood counts, no circulating blasts, neutrophil count ≥ 1.0 ×109/L, platelet count ≥ 100 ×109/L, bone marrow aspirate and biopsy, ≤5% blasts, no detectable auer rods, no extramedulary leukemia

  Up to 4 months

Secondary Outcomes (4)

• Evaluation of CR Duration

  Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.

• Disease-free Survival

  Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.

• Overall Survival

  Up to 5 years after completion of active treatment and while on study. Participants may receive up to 24 courses of study medication.

• Induction Mortality

  Up to 1 year

Study Arms (1)

Omacetaxine and Cytarabine

EXPERIMENTAL

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; Drug: Cytarabine

Interventions

Omacetaxine DRUG

1.25 mg/m2 subcutaneously (SQ) every 12 hours (+/- 3 hours) for 3 days (Days 1-3). Each cycle will be 4-7 weeks.

Omacetaxine and Cytarabine

Cytarabine DRUG

20 mg subcutaneously every 12 hours (+/- 3 hours) for 7 days (Days 1-7). Each cycle will be 4-7 weeks.

Also known as: ARA-C, Cytosar, Depo-Cyt, Cytosine Arabinosine Hydrochloride

Omacetaxine and Cytarabine

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously untreated AML (\>/= 20% blasts). Patients with high-risk (intermediate-2 or high by International Prostate Symptom Score (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.
• Age \>/= 60 years.
• Eastern Cooperative Oncology Group (ECOG) performance status \</= 2.
• Adequate hepatic (serum total bilirubin \</= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) \</= 2.5 x ULN) and renal function (creatinine \</= 2.0 mg/dL).
• Patients must be willing and able to review, understand, and provide written consent before starting therapy.

You may not qualify if:

• 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), diabetes mellitus, or congestive heart failure.
• Myocardial infarction in the previous 12 weeks (from the start of treatment).
• Active and uncontrolled disease/infection as judged by the treating physician.
• Pregnancy.
• Acute promyelocytic leukemia (APL).
• Women of childbearing potential and men who do not practice contraception. Non-childbearing is defined as \>/= 1 year postmenopausal or surgically sterilized.
• Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Cephalon: collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute

Interventions

Homoharringtonine; Cytarabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid

Intervention Hierarchy (Ancestors)

Harringtonines; Alkaloids; Heterocyclic Compounds; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 4 or More Rings; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Kantarjian,Hagop M
• Organization: UT MD Anderson Cancer Center

CR_Study_Registration@mdanderson.org

713-792-7026

Study Officials

• Hagop Kantarjian, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2011
• First Posted: January 7, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 30, 2018
• Results First Posted: May 30, 2018

Record last verified: 2018-04

Locations

US (1)