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Recruiting NCT06569082

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

No phase Interventional Graft Failure Poor Graft Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD34+ Selected Donor Cell Boost, Blood Stem Cell Infusion.
Who it may be relevant to
Registry conditions: Graft Failure, Poor Graft Function. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device CD34+ Selected Donor Cell Boost
    The 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.
  • Procedure Blood Stem Cell Infusion
    The selected CD34 cells separated by the CliniMACS CD34 Reagent System are infused into the recipient.

Primary outcome measures

  • Number of Participants with Absolute Neutrophil Cell (ANC) Engraftment [Time frame: Day 100 Post-Procedure]
  • Number of Participants with Platelet Engraftment [Time frame: Day 100 Post-Procedure]
Secondary outcome measures (2)
  • Number of Participants with Grade II-IV Acute GVHD [Time frame: Day 100 Post-Procedure]
  • Number of Participants with Moderate to Severe Chronic GVHD [Time frame: Day 365 Post-Procedure]

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):
  • 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.

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • NYU Langone Health — New York

Identifiers

NCT: NCT06569082 · 23-00885

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗