CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health
About this trial
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 criteria
Qualifiers
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.
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CD34+ Selected Donor Cell Boost
- Blood Stem Cell Infusion
Treatment groups
21 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov