Hematologic Neoplasms Clinical Trial
Official title:
A Phase II Study Evaluating the Safety and Efficacy of Intravenous AMD3100 for the Mobilization and Transplantation of HLA-Matched Sibling Donor Hematopoietic Stem Cells in Patients With Advanced Hematological Malignancies
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 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 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 GVHD and chronic GVHD in patients who receive IV AMD3100
mobilized peripheral blood stem cells.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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