RECRUITING

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

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Conditions

Graft FailurePoor Graft Function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-10-31
Study Completion:2035-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06569082

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Documented evidence of graft dysfunction or failure (a-c):
  3. 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;
  4. 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;
  5. 3. Secondary graft failure is defined as poor graft function associated with donor chimerism \< 5% after initial engraftment
  6. * Transplanted donor availability
  7. * Negative pregnancy test within seven (7) days of product infusion for women of childbearing potential.
  1. * Graft failure due to disease relapse or evidence of disease relapse or progression
  2. * Donor unavailable or unable to collect peripheral HPC by apheresis
  3. * Responsive to conventional measures (such as, hematopoietic growth factor)
  4. * Allergic reaction to murine proteins or iron dextran
  5. * Women of childbearing potential with positive serum HCG

Contacts and Locations

Study Contact

Kiselle Mangalindan
CONTACT
646-501-2973
KiselleAnne.Mangalindan@nyulangone.org
Kelsey Stocker
CONTACT
646-501-4848
Kelsey.Stocker@nyulangone.org

Principal Investigator

Jingmei Hsu
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Jingmei Hsu, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-31
Study Completion Date2035-08

Study Record Updates

Study Start Date2024-10-31
Study Completion Date2035-08

Terms related to this study

Additional Relevant MeSH Terms

  • Graft Failure
  • Poor Graft Function