Clinical trial NCT06569082: CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure
Official title: CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Graft Failure
Poor Graft Function
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary objective of the study is to estimate the incidence of engraftment with sustained recovery of blood counts, including, absolute neutrophil cell (ANC) and platelet engraftment.

* ANC engraftment is defined as ANC of ≥ 0.5 × 10\^9/L for three consecutive laboratory values obtained on different days. Date of ANC recovery is the date of the first of three consecutive laboratory values where the ANC is ≥ 0.5 × 10\^9/L.
* Platelet engraftment should reflect no platelet transfusions administered for seven consecutive days. Report the date of the first of three consecutive laboratory values ≥ 20 × 10\^9/L obtained on different days.

The secondary objective of the study is to estimate the incidence of Graft-versus-host disease (GvHD) and side effects that can be attributed to the CliniMACS CD34 Selected Cellular Product.

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

Primary outcomes:
measure: Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment
timeFrame: Day 100 Post-Procedure
measure: Number of Participants with Platelet Engraftment
timeFrame: Day 100 Post-Procedure
Secondary outcomes:
measure: Number of Participants with Grade II-IV Acute GVHD
timeFrame: Day 100 Post-Procedure
measure: Number of Participants with Moderate to Severe Chronic GVHD
timeFrame: Day 365 Post-Procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Jingmei Hsu
role: PRINCIPAL_INVESTIGATOR
References: