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Induction Therapy With Decitabine and Plerixafor Priming for Patients ≥ 60 Years With Acute Myeloid Leukemia

Phase 1
60 Years
Open (Enrolling)
Acute Myeloid Leukemia

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Trial Information

Induction Therapy With Decitabine and Plerixafor Priming for Patients ≥ 60 Years With Acute Myeloid Leukemia

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

- Patient has an inability or unwillingness, in the opinion of the investigator, to
comply with the protocol requirements.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response to treatment

Outcome Description:

blood and bone marrow testing will be done to determine response to treatment every month

Outcome Time Frame:

after every cycle (every month) - average subject will be on study for 4-6 months

Safety Issue:


Principal Investigator

Gail Roboz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • Acute Myeloid Leukemia
  • leukemia
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid



Weill Cornell Medical CollegeNew York, New York  10021