Feasibility and Efficiency Study of Leukemic Cell Mobilization With Plerixafor Injection

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborator: Princess Margaret Hospital, Canada
• Treatments: Busulfan; Fludarabine; Fludarabine phosphate; JM 3100; Plerixafor

Criteria

Inclusion Criteria:

• Patients with AML in remission.

• Availability of a suitably matched related or unrelated donor

• Age 18-60 years

• Eligibility for a myeloablative transplant using the Institutional protocols R-FBT(400)-CSMF as preparative regimen for related donors and U-FBT(400)-CP(30)CS for unrelated donors.

• Eligible subjects who are illiterate will be offered participation in the study

Exclusion criteria:

• Patients aged 61years or older

• Patients not eligible for the preparative regimens R-FBT(400)-CSMF or U-FBT(400)-CP(30)CS

• Pregnant or lactating females

• Creatinine of .>2x normal

• Bilirubin, AST, ALT > 2x normal

• MUGA of <50%