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

Not Applicable

Not yet recruiting

• Conditions: Graft Failure; Poor Graft Function

• Registration Number: NCT06569082
• Lead Sponsor: NYU Langone Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-8-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

Inclusion Criteria:<br><br> - Recipient of allogeneic transplantation, adult =18 years, from any type of donor<br> including matched related, matched unrelated, mismatched related or mismatched<br> unrelated or haploidentical donor transplant.<br><br> - Documented evidence of graft dysfunction or failure (a-c):<br><br> 1. Primary graft Failure: Graft failure is defined as failure to achieve<br> neutrophil engraftment by day +28 or lack of donor chimerism > 50% by day 45<br> not due to the underlying malignancy;<br><br> 2. Poor graft function is defined by at least 2 of the following 3 criteria:<br> Hemoglobin < 8 g/dL, ANC < 0.5x109/L, and platelets < 20x109/L. The cytopenia<br> must be unexplained (such as by disease relapse) and unresponsive to<br> hematopoietic growth factors and must last at least 4 weeks;<br><br> 3. Secondary graft failure is defined as poor graft function associated with donor<br> chimerism < 5% after initial engraftment<br><br> - Transplanted donor availability<br><br> - Negative pregnancy test within seven (7) days of product infusion for women of<br> childbearing potential.<br><br>Exclusion Criteria:<br><br> - Graft failure due to disease relapse or evidence of disease relapse or progression<br><br> - Donor unavailable or unable to collect peripheral HPC by apheresis<br><br> - Responsive to conventional measures (such as, hematopoietic growth factor)<br><br> - Allergic reaction to murine proteins or iron dextran<br><br> - Women of childbearing potential with positive serum HCG

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment;Number of Participants with Platelet Engraftment

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Grade II-IV Acute GVHD;Number of Participants with Moderate to Severe Chronic GVHD