Clinical Trials /

Decitabine and Plerixafor in Elderly Acute Myeloid Leukemia (AML)

NCT01352650

Description:

The hypothesis of this proposal is that combining plerixafor, an inhibitor of stromal cell derived factor - 1α (SDF-1α), with decitabine, a DNA methyltransferase inhibitor, as induction and postremission therapy for older patients with Acute Myeloid Leukemia (AML) will improve treatment outcomes via mobilization of leukemia stem cells and alteration of the pharmacodynamics of decitabine. The protocol will establish the safety and feasibility of combining two different doses of plerixafor with a fixed dose and schedule of decitabine.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Decitabine and Plerixafor in Elderly Acute Myeloid Leukemia (AML)
  • Official Title: Induction Therapy With Decitabine and Plerixafor Priming for Patients ≥ 60 Years With Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: 1104011617
  • NCT ID: NCT01352650

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
plerixaforMOZOBILCohort 2B
decitabineDacogenCohort 2B

Purpose

The hypothesis of this proposal is that combining plerixafor, an inhibitor of stromal cell derived factor - 1α (SDF-1α), with decitabine, a DNA methyltransferase inhibitor, as induction and postremission therapy for older patients with Acute Myeloid Leukemia (AML) will improve treatment outcomes via mobilization of leukemia stem cells and alteration of the pharmacodynamics of decitabine. The protocol will establish the safety and feasibility of combining two different doses of plerixafor with a fixed dose and schedule of decitabine.

Trial Arms

NameTypeDescriptionInterventions
Cohort 1AActive ComparatorCycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 2: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 4: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5
  • plerixafor
  • decitabine
Cohort 1BActive ComparatorCycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5 Cycle 2: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 320 mcg/kg IV on days 1-5 Cycle 4: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10
  • plerixafor
  • decitabine
Cohort 2AActive ComparatorCycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 2: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 540 mcg/kg IV on days 1-5 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 4: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 540 mcg/kg IV on days 1-5
  • plerixafor
  • decitabine
Cohort 2BActive ComparatorCycle 1: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 540 mcg/kg IV on days 1-5 Cycle 2 decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 3: decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 540 mcg/kg IV on days 1-5 Cycle 4 decitabine 20 mg/m2 IV daily for a 1-hour infusion on days 1-10
  • plerixafor
  • decitabine
Cohort 3AActive ComparatorCycle 1: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 2: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 810 mcg/kg IV on days 1-5 Cycle 3: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 4: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 810 mcg/kg IV on days 1-5
  • plerixafor
  • decitabine
Cohort 3BActive ComparatorCycle 1: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 810 mcg/kg IV on days 1-5 Cycle 2: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 Cycle 3: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10 + plerixafor 810 mcg/kg IV on days 1-5 Cycle 4: decitabine 20mg/m2 IV daily for a 1-hour infusion on days 1-10
  • plerixafor
  • decitabine

Eligibility Criteria

        Inclusion Criteria:

          -  Unequivocal pathologic diagnosis of AML (≥ 20% blasts in the bone marrow based on WHO
             criteria) excluding: i) acute promyelocytic leukemia t(15;17)(q22;q12); PML-RARA;
             ii)acute myeloid leukemia with t(8;21)(q22;q22); RUNX1-RUNXT1; iii) acute myeloid
             leukemia with inv(16)(p13.1;q22) or t(16;16)(p13.1;q22); CBFB-MYH11.

          -  AML patients with an antecedent hematologic disorder or myelodysplastic syndrome
             (MDS)are eligible for treatment on this trial provided that they have not received
             prior treatment with decitabine or prior cytotoxic treatment for AML.

          -  AML patients with therapy-related myeloid neoplasms (t-MN) are eligible if they have
             not received chemotherapy (not including hormonal therapy) for their primary
             malignancy or disorder for >6 months.

          -  Age ≥ 60 years.

          -  Ability to understand and willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Prior treatment with decitabine

          -  Prior treatment with plerixafor

          -  Ongoing treatment for another malignancy.

          -  Patients with good-risk molecular or cytogenetics features

          -  Patient has a medical condition or illness considered by the investigator to
             constitute an unwarranted high risk for investigational drug treatment.

          -  Patient has a psychiatric disorder or altered mental status that would preclude
             understanding of the informed consent process and/or completion of the necessary
             studies.

          -  Patient has an inability or unwillingness, in the opinion of the investigator, to
             comply with the protocol requirements.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:60 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:response to treatment
Time Frame:after every cycle (every month) - average subject will be on study for 4-6 months
Safety Issue:
Description:blood and bone marrow testing will be done to determine response to treatment every month

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Weill Medical College of Cornell University

Trial Keywords

  • leukemia

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