To reduce the number of donors treated with IV AMD3100 who require a second collection to obtain the minimum cells necessary for allogeneic stem cell transplant.
* To reduce the number of donors treated with intravenous (IV) AMD3100 who require a second collection to obtain the minimum CD34/kg (2 X 106) necessary for allogeneic stem cell transplantation when compared to our historic group who received 240ug SC AMD3100 from 33% (8 in 24) to 11% (3 in 27). * To estimate with 95% confidence intervals the proportion of human leukocyte antigen (HLA)-identical sibling donors who experience grade 3-4 infusional toxicity and the proportion from whom ≥ 2.0 x 10e6 CD34+ cells/kg recipient weight are safely mobilized following one or two intravenous infusions. * To determine the kinetics of stem cell and lymphocyte mobilization using IV AMD3100 and to determine if peripheral blood stem cell products collected after mobilization with IV AMD3100 can be used safely for hematopoietic cell transplantation in HLA-matched recipients as measured by neutrophil engraftment by day +21. * To determine the pharmacokinetics and pharmacodynamics of IV AMD3100 on stem cell and T-cell phenotyping and on immune reconstitution after transplantation. * To determine the rate of acute graft-versus-host disease (GVHD) and chronic GVHD in patients who receive IV AMD3100 mobilized peripheral blood stem cells.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
68
Washington University School of Medicine
St Louis, Missouri, United States
Number of Donors Treated With IV AMD3100 Who Required a Second Collection to Obtain the Minimum CD34/kg (2 X 106) Necessary for Allogeneic Stem Cell Transplant
Time frame: Completion of enrollment of all donors (17 months)
Number of Donors Who Experience Grade 3-4 Infusional Toxicity
Time frame: Up to Day 2
Number of Recipients Who Have Neutrophil Engraftment
Time frame: Day 21
Pharmacokinetics of IV AMD3100 as Measured by the Mean Maximum Plasma Concentration (Cmax)
-Blood samples for pharmacokinetics were drawn on the following schedule: * prior to IV infusion * 15 minutes after start of infusion * 30 minutes after start of infusion * 1 hour after start of infusion * 4 hours after start of infusion * 6 hours after start of infusion * 9 hours after start of infusion * 24 hours after start of infusion
Time frame: Day 1 and Day 2
Pharmacokinetics of IV AMD3100 as Measured by Half Life
-Blood samples for pharmacokinetics were drawn on the following schedule: * prior to IV infusion * 15 minutes after start of infusion * 30 minutes after start of infusion * 1 hour after start of infusion * 4 hours after start of infusion * 6 hours after start of infusion * 9 hours after start of infusion * 24 hours after start of infusion
Time frame: Day 1 and Day 2
Pharmacokinetics of IV AMD3100 as Measured by Mean Area Under Curve (AUC)
Time frame: Day 1 and Day 2
Rate of Acute GVHD (Grade II-IV) in Recipients
Time frame: Day 0-Day 100 (acute)
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Rate of Acute GVHD (Grade III-IV) in Recipients
Time frame: Day 0-Day 100 (acute)
Time to Neutrophil Engraftment for Recipients
Measured by determine the first 3 consecutive measurement of neutrophil count = 500/ul following conditioning regimen induced nadir.
Time frame: Up through Day 100
Time to Platelet Engraftment for Recipients
Measured by determining the first of 3 consecutive measurements of platelet count = 20,000/ul without platelet transfusion support for 7 days.
Time frame: Up to Day 100
Transplant Related Mortality Rate for Recipients
Death that results from a transplant procedure related complication rather than from relapse of the underlying disease or unrelated cause.
Time frame: Day 100
Grade 3-4 Toxicity for Recipients
Assessed and graded according to NCI Common Terminology for Adverse Events Version 3.0.
Time frame: 1 year
Rate of Chronic GVHD in Recipients
Time frame: Day 101-1 year
Number of Donors Who Experience Grade 3-4 Mobilization Toxicity Due to Pheresis Procedure
Time frame: Up to Day 2