Feasibility and Efficiency Study of Leukemic Cell Mobilization With Plerixafor Injection
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
The study will be conducted as a single center Phase I/II study to evaluate the safety of
administering Plerixafor administered as part of a myeloablative preparative regimen
(Institutional Protocol:Fludarabine 50mg/m2/da x 4 days, Busulfan 3.2mg/kg/day x 4 days, TBI
400cGy in divided fractions) for stem cell transplant recipients with AML and to determine
whether or not residual leukemic stem cells can be mobilized. Three patients will be enrolled
into each of 4 sequential cohorts. Patients in the first cohort will receive 1 dose of
Plerixafor (240mcg/kg sc) prior to administration of the first dose of Fludarabine and
Busulfan. If tolerated it is planned to escalate the number of Plerixafor doses in the
subsequent cohorts to 2. 3. and 4 to be administered before the respective 2nd, 3rd, and 4th
dose of chemotherapy.
Details
Lead Sponsor:
University Health Network, Toronto
Collaborator:
Princess Margaret Hospital, Canada
Treatments:
Busulfan Fludarabine Fludarabine phosphate JM 3100 Plerixafor