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

Description

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.

Conditions

Graft Failure, Poor Graft Function

Study Overview

Study Details

Study 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.

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

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

Condition
Graft Failure
Intervention / Treatment

-

Contacts and Locations

New York

NYU Langone Health, New York, New York, United States, 10016

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NYU Langone Health,

Jingmei Hsu, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

2035-08