Status:
RECRUITING
CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
Lead Sponsor:
NYU Langone Health
Conditions:
Graft Failure
Poor Graft Function
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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) requir...
Detailed Description
The primary objective of the study is to estimate the incidence of engraftment with sustained recovery of blood counts, including, absolute neutrophil cell (ANC) and platelet engraftment. * ANC engra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Graft failure due to disease relapse or evidence of disease relapse or progression
- Donor unavailable or unable to collect peripheral HPC by apheresis
- Responsive to conventional measures (such as, hematopoietic growth factor)
- Allergic reaction to murine proteins or iron dextran
- Women of childbearing potential with positive serum HCG
Key Trial Info
Start Date :
October 31 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2035
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06569082
Start Date
October 31 2024
End Date
August 1 2035
Last Update
September 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
NYU Langone Health
New York, New York, United States, 10016