CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation

Status: Recruiting
Location: See location...
Intervention Type: Device, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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) requiring treatment of graft dysfunction or failure.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
NYU Langone Health
RECRUITING
New York
Contact Information
Primary
Kiselle Mangalindan
KiselleAnne.Mangalindan@nyulangone.org
646-501-2973
Backup
Kelsey Stocker
Kelsey.Stocker@nyulangone.org
646-501-4848
Time Frame
Start Date: 2024-10-31
Estimated Completion Date: 2035-08
Participants
Target number of participants: 21
Treatments
Experimental: Individuals with Poor Graft Function or Failure Following Allogeneic HSCT
The recipient will undergo evaluations, then undergo a single infusion of CD34 selected HSCT from the original donor.~No additional GvHD prophylaxis will be administered. Patients who develop GvHD will receive the standard of care based on the discretion of the treating physician .~Patients will receive supportive care per institutional standards and at the discretion of the treating physician.
Related Therapeutic Areas
Sponsors
Leads: NYU Langone Health

This content was sourced from clinicaltrials.gov