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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CD34+ Selected Donor Cell Boost
DeviceThe CliniMACS CD34 Reagent System is used to separate CD34 cells from the remaining stem cell product, using a peripheral blood stem cell sample provided by the original donor. These CD34 cells are then infused into the recipient following selection with the intent to restore function of the blood forming cells.
Blood Stem Cell Infusion
Procedure/SurgeryThe selected CD34 cells separated by the CliniMACS CD34 Reagent System are infused into the recipient.
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: Individuals with Poor Graft Function or Failure Following Allogeneic HSCTExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment
ANC engraftment is defined as ANC of ≥ 0.5 × 10\^9/L for three consecutive laboratory values obtained on different days.
Time frame
Day 100 Post-Procedure2
Number of Participants with Platelet Engraftment
Platelet engraftment is defined as no platelet transfusions administered for seven consecutive days.
Time frame
Day 100 Post-ProcedureSecondary outcomes
1
Number of Participants with Grade II-IV Acute GVHD
The diagnosis of acute GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician.
Time frame
Day 100 Post-Procedure2
Number of Participants with Moderate to Severe Chronic GVHD
The diagnosis of chronic GvHD is based on clinical and pathological evaluation by the principal investigator in collaboration with the treating physician.
Time frame
Day 365 Post-ProcedureSponsors and contacts
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Source ClinicalTrials.gov