drugset / Trial / NCT01352650
Decitabine and Plerixafor in Elderly Acute Myeloid Leukemia (AML)
Phase 1
Completed
71 enrolled
Weill Medical College of Cornell University
Genzyme, a Sanofi Company · collab
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2011-06-17
- Primary completion
- 2016-12-27
- Completion
- 2016-12-27
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Plerixafor | Small molecule | 320 ug/kg | Intravenous |
| Comparator | Plerixafor | Small molecule | 540 ug/kg | Intravenous |
| Comparator | Plerixafor | Small molecule | 810 ug/kg | Intravenous |
| Comparator | Decitabine | Small molecule | 20 mg/m2 | Intravenous |