The purpose of this study is to determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.
This study will determine if peripheral blood cells collected following AMD3100 mobilization can be used safely for hematopoietic cell transplantation into HLA-matched recipients.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Washington University School of Medicine
St Louis, Missouri, United States
Proportion of Donors From Whom a Sufficient Number of Cells for Transplantation Are Collected in no More Than 2 LP Procedures Following Mobilization With AMD3100 (Donor Only)
-Defined as the proportion of donors collecting \>2.0x106 CD34+ cells/kg \[recipient weight\]
Time frame: Day 1-3
Proportion of Recipients Who Experience Grade 2-4 Acute GVHD (Recipient Only)
-Incidence and severity of acute GVHD (aGVHD) will be assessed based on the Seattle criteria
Time frame: By Day 100 after transplant
Proportion of Recipients Who Successfully Engraft by Day +21 After Transplant (Recipient Only)
-Defined as neutrophil count ≥ 500/ul following conditioning regimen induced nadir
Time frame: Day +21
Proportion of Recipients Who Experience Chronic GVHD (Recipient Only)
-Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria
Time frame: Between Day +100 and +365 post-transplant
Proportion of Recipients Who Experience Mortality Before Day 100 After Transplant (Recipient Only)
-Death that results from a transplant procedure related complication (e.g. infection, organ failure, hemorrhage, GVHD) rather than from relapse of the underlying disease or an unrelated cause
Time frame: 100 days after transplant
Quality of Life During Stem Cell Mobilization (Recipients Only)
Time frame: 48-72 hours after last dose of AMD3100
Proportion of Donors Who Experience Infusional Toxicity (Donor Only)
-Defined as hypersensitivity reactions. Evaluated by physical exam, blood pressure, heart rate, respirations and temperature one hour prior to the infusion and then 15 minutes, 30 minutes, one hour, 2 hours, and 4 hours post-infusion
Time frame: Day +1 to +3 (SC donor arm) and Day -3 to +3 (IV donor arm)
To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Cmax
-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion
Time frame: 0 to 24 hours after dose of IV AMD3100
To Determine the Pharmacokinetics of IV AMD3100 (IV Donor Arm Only) as Measured by Mean AUC From Time 0 to Infinity
-Blood for pharmacokinetics were drawn prior to infusion, 15 minutes after infusion, 30 minutes after infusion, 45 minutes after infusion, 1 hour after infusion, 2 hours after infusion, 4 hours after infusion, 6 hours after infusions, and 24 hours after infusion
Time frame: 0 to 24 hours after dose of IV AMD3100
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