Clinical Trial: Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: OAG and Decitabine for Newly Diagnosed Acute Myeloid Leukemia Patients Greater Than or Equal to 65 Years of Age

Brief Summary: This phase II trial studies the side effects and how well omacetaxine mepesuccinate, cytarabine, and decitabine work in treating older patients with newly diagnosed acute myeloid leukemia. Omacetaxine mepesuccinate, cytarabine, and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To study the complete response rate following OAG (omacetaxine mepesuccinate, cytarabine) in newly diagnosed acute myeloid leukemia patients unfit for intensive induction therapy.

II. To assess the toxicity of OAG using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0).

SECONDARY OBJECTIVES:

I. To study the disease-free and overall survival of OAG and decitabine in newly diagnosed acute myeloid leukemia patients unfit for intensive induction therapy.

OUTLINE:

INDUCTION CHEMOTHERAPY: Patients receive cytarabine subcutaneously (SC) twice daily (BID) and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve complete response (CR) in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine intravenously (IV) on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 3 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Sponsor: Roswell Park Cancer Institute

Current Primary Outcome:

• Proportion of the Evaluable Population of Interest Who Experience a Complete Response in the Poor and Good Prognosis Groups [ Time Frame: Up to 4 years ]
  Defined as recovery of morphologically normal bone marrow (< 5% blasts) and blood counts (absolute neutrophil count >= 1x10^9/L, platelet counts >= 100x10^9/LO) and rare circulating leukemic blasts or evidence of extramedullary disease. Analyzed using exact binomial probabilities in a two-stage design. The number of responses will be tabulated.
• Frequency of Adverse Events, Graded According to NCI CTCAE v4.0 [ Time Frame: Up to 30 days after last dose of study drugs ]
  Maximum grade per participant of any AE.

Original Primary Outcome:

• Proportion of the Evaluable Population of Interest Who Experience a Complete Response in the Poor and Good Prognosis Groups [ Time Frame: Up to 2 years ]
  Defined as recovery of morphologically normal bone marrow (< 5% blasts) and blood counts (absolute neutrophil count [ANC] >= 1x10^9/L, platelet counts >= 100x10^9/LO) and rare circulating leukemic blasts or evidence of extramedullary disease. Analyzed using exact binomial probabilities in a two-stage design.
• Frequency of Adverse Events, Graded According to NCI CTCAE v4.0 [ Time Frame: Up to 30 days after last dose of study drugs ]
  Tabulated by grade across.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Roswell Park Cancer Institute

Dates:
Date Received: January 6, 2014
Date Started: July 2014
Date Completion:
Last Updated: April 5, 2016
Last Verified: April 2016