CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure

Launched by NYU LANGONE HEALTH · Aug 22, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients who have had a stem cell transplant but are experiencing problems with their graft, which is the new stem cells that were infused into their bodies. Specifically, the trial is looking at a technique called the CliniMACS CD34 Reagent System, which is used to select specific stem cells to improve graft function or address graft failure. This study is currently recruiting adult patients aged 18 and older who have documented evidence of graft dysfunction or failure, which can include a lack of proper blood cell production after the transplant.

To be eligible for this trial, participants must have received an allogeneic stem cell transplant from any type of donor and have specific signs of graft issues, such as low blood cell counts that are not responding to standard treatments. Patients will be monitored closely throughout the study to see if this new approach helps improve their condition. It’s also important to know that women who can become pregnant will need to have a negative pregnancy test before starting the treatment. Overall, this trial aims to find better solutions for patients struggling with graft problems after their transplant.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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):
• • 1. 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;
• • 2. 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;
• • 3. 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 Criteria:
• • 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