Status:
COMPLETED
Feasibility and Efficiency Study of Leukemic Cell Mobilization With Plerixafor Injection
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
18-61 years
Brief 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:F...
Detailed Description
The study will be conducted as a single center Phase I/II study to evaluate the safety of administering PLERIXAFOR as part of a myeloablative preparative regimen (Institutional Protocol: FBT(400) - FL...
Eligibility Criteria
Inclusion
- 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%
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01141543
Start Date
May 1 2010
End Date
May 1 2014
Last Update
July 18 2014
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9