This research study tests a new medicine for mobilizing stem cells so they can be collected and used for allogeneic stem cell transplant for treatment of hematological malignancies. MGTA-145, the new medicine, will be given with plerixafor.
This is a Phase II, open-label, multicenter, prospective study of MGTA-145 + plerixafor mobilized HLA-matched sibling and matched unrelated donor allografts for myeloablative hematopoietic stem cell transplantation (HSCT) in recipients with hematological malignancies. Donors will undergo 1 or 2 days of mobilization and apheresis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
MGTA-145 will be be administered as an IV infusion
240 µg/kg subcutaneously
City of Hope National Medical Center
Duarte, California, United States
Stanford Health Care
Stanford, California, United States
Emory University Hospital
Atlanta, Georgia, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
HSC Yield in Apheresis Product
Number of subjects with adequate number of hematopoietic stem cells (≥ 2.0 x 10\^6 CD34+ cells/kg) in one apheresis setting.
Time frame: Up to 2 days
HSC Yield in Apheresis Product
To determine the proportion of donors whose cells can be successfully mobilized and collected with a target CD34+ cell dose of at least 4.0 x 10\^6 CD34+ cells/kg actual recipient weight in one apheresis collection
Time frame: Up to 2 days
Adverse Events Experienced by Donors
To ascertain the incidence of adverse events (AEs) before and during apheresis experienced by donors receiving MGTA-145 + plerixafor
Time frame: Baseline though day 180
Graft Durability
The proportion of participants with primary and secondary graft failure after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
Time frame: Day 28
Graft-versus Host Disease (GVHD)
To determine the incidence of acute and chronic graft versus host disease (GVHD) after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
Time frame: Day 100
Treatment-related Mortality
To determine the proportion of treatment-related mortality and disease relapse/progression after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
Time frame: Day 100
Overall Survival
To determine the probability of overall survival after transplantation of hematopoietic cells mobilized with MGTA-145 + plerixafor
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Roswell Park Cancer Institute
Buffalo, New York, United States
Ohio State Medical Center, James Cancer Center
Columbus, Ohio, United States
M.D. Anderson Cancer Center
Houston, Texas, United States
Be The Match Collection Center Seattle
Seattle, Washington, United States
Time frame: Day 100