Clinical trial NCT01352650: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myeloid Leukemia
Keywords: leukemia
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2011-05-12
Enrollment: 71
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: response to treatment
timeFrame: after every cycle (every month) - average subject will be on study for 4-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Gail Roboz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roboz GJ, Ritchie EK, Dault Y, Lam L, Marshall DC, Cruz NM, Hsu HC, Hassane DC, Christos PJ, Ippoliti C, Scandura JM, Guzman ML. Phase I trial of plerixafor combined with decitabine in newly diagnosed older patients with acute myeloid leukemia. Haematologica. 2018 Aug;103(8):1308-1316. doi: 10.3324/haematol.2017.183418. Epub 2018 May 3.
citation: Allan JN, Roboz GJ, Askin G, Ritchie E, Scandura J, Christos P, Hassane DC, Guzman ML. CD25 expression and outcomes in older patients with acute myelogenous leukemia treated with plerixafor and decitabine. Leuk Lymphoma. 2018 Apr;59(4):821-828. doi: 10.1080/10428194.2017.1352089. Epub 2017 Jul 18.