CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation
The proposed trial is a single arm, non-randomized, single center pilot study utilizing CliniMACS CD34 Reagent System for patients following allogeneic hematopoietic stem cell transplant (HSCT) requiring treatment of graft dysfunction or failure.
• Recipient of allogeneic transplantation, adult ≥18 years, from any type of donor including matched related, matched unrelated, mismatched related or mismatched unrelated or haploidentical donor transplant.
• Documented evidence of graft dysfunction or failure (a-c):
‣ Primary graft Failure: Graft failure is defined as failure to achieve neutrophil engraftment by day +28 or lack of donor chimerism \> 50% by day 45 not due to the underlying malignancy;
⁃ Poor graft function is defined by at least 2 of the following 3 criteria: Hemoglobin \< 8 g/dL, ANC \< 0.5x109/L, and platelets \< 20x109/L. The cytopenia must be unexplained (such as by disease relapse) and unresponsive to hematopoietic growth factors and must last at least 4 weeks;
⁃ Secondary graft failure is defined as poor graft function associated with donor chimerism \< 5% after initial engraftment
• Transplanted donor availability
• Negative pregnancy test within seven (7) days of product infusion for women of childbearing potential.