Decitabine and Plerixafor in Elderly Acute Myeloid Leukemia (AML)
| Status: | Completed |
|---|---|
| Conditions: | Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 7/4/2018 |
| Start Date: | June 17, 2011 |
| End Date: | December 27, 2016 |
Induction Therapy With Decitabine and Plerixafor Priming for Patients ≥ 60 Years With Acute Myeloid Leukemia
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.
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.
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.
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