A Phase II Study Evaluating the Safety and Efficacy of Subcutaneous Plerixafor

Phase 2 Completed 127 enrolled Center for International Blood and Marrow Transplant Research Genzyme, a Sanofi Company · collab Sanofi · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a Phase II, open-label, two strata, multicenter, prospective study of plerixafor-mobilized HLA-identical sibling allografts in recipients with hematological malignancies. This study will establish the safety and efficacy of subcutaneous plerixafor for this purpose.

Timeline

Start: 2013-05
Primary completion: 2016-08
Completion: 2016-08

Outcome

Met primary endpoint

paper Sixty-three of 64 (98%) donors achieved the primary objective. PMID 30890544 ↗

Publications

Chen YB, Le-Rademacher J, Brazauskas R, Kiefer DM, Hamadani M, DiPersio JF, Litzow MR, Craig M, Horwitz ME, Artz AS, McClune BL, Fernandez HF, Duong HK, Kobusingye H, Proue M, Drexler RJ, Horowitz MM, Shaw BE, Miller JP, Hosoba S, Waller EK, Devine SM. Plerixafor alone for the mobilization and transplantation of HLA-matched sibling donor hematopoietic stem cells. Blood Adv. 2019 Mar 26;3(6):875-883. doi: 10.1182/bloodadvances.2018027599.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plerixafor	Small molecule	240 ug/kg	Subcutaneous