Clinical Trials /

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

NCT02029417

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Terminated

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Omacetaxine Mepesuccinate, Cytarabine, and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
  • Official Title: OAG and Decitabine for Newly Diagnosed Acute Myeloid Leukemia Patients Greater Than or Equal to 65 Years of Age

Clinical Trial IDs

  • ORG STUDY ID: I 245213
  • SECONDARY ID: NCI-2013-02425
  • SECONDARY ID: I 245213
  • SECONDARY ID: P30CA016056
  • NCT ID: NCT02029417

Conditions

  • Acute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome
  • Adult Acute Megakaryoblastic Leukemia (M7)
  • Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
  • Adult Acute Monoblastic Leukemia (M5a)
  • Adult Acute Monocytic Leukemia (M5b)
  • Adult Acute Myeloblastic Leukemia With Maturation (M2)
  • Adult Acute Myeloblastic Leukemia Without Maturation (M1)
  • Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
  • Adult Acute Myeloid Leukemia With Del(5q)
  • Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
  • Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
  • Adult Acute Myelomonocytic Leukemia (M4)
  • Adult Erythroleukemia (M6a)
  • Adult Pure Erythroid Leukemia (M6b)
  • Secondary Acute Myeloid Leukemia
  • Untreated Adult Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
cytarabineARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinosideTreatment (cytarabine, omacetaxine mepesuccinate, decitabine)
omacetaxine mepesuccinateCGX-635, homoharringtonineTreatment (cytarabine, omacetaxine mepesuccinate, decitabine)
decitabine5-aza-dCyd, 5AZA, DACTreatment (cytarabine, omacetaxine mepesuccinate, decitabine)

Purpose

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 Description

      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.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (cytarabine, omacetaxine mepesuccinate, decitabine)ExperimentalINDUCTION CHEMOTHERAPY: Patients receive cytarabine SC 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 CR in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine 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.
  • cytarabine
  • omacetaxine mepesuccinate
  • decitabine

Eligibility Criteria

        Inclusion Criteria:

          -  Patients who are not eligible for standard induction chemotherapy (or any standard
             therapy known to be life prolonging) because of poor performance status, significant
             tissue comorbidities, or unfavorable risk of disease

          -  Have an unequivocal histologic diagnosis of acute myeloid leukemia (AML) (including
             secondary AML)

          -  No prior therapy for AML except hydroxyurea to control counts

          -  Must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of
             birth control; abstinence) prior to study entry and for the duration of study
             participation

          -  Subject or legal representative must understand the investigational nature of this
             study and sign an independent ethics committee/institutional review board approved
             written informed consent form prior to receiving any study related procedure

        Exclusion Criteria:

          -  Subjects with the diagnosis of acute promyelocytic leukemia (t[15;17])

          -  Unwilling or unable to follow protocol requirements

          -  Any condition which in the investigator's opinion deems the subject an unsuitable
             candidate to receive study drug

          -  Patients with sickle cell disease and sickle cell crisis

          -  Received an investigational agent for another disease within 30 days prior to
             enrollment

          -  The patient has an uncontrolled and active infection that would preclude study conduct
             and assessment
      
Maximum Eligible Age:N/A
Minimum Eligible Age:65 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description: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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Terminated
Lead Sponsor:Roswell Park Cancer Institute

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