RECRUITING

UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

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

Patients with graft failure or delayed engraftment may benefit from a hematopoietic stem cell boost or an additional hematopoietic stem cell transplantation procedure. In such settings standard immune suppression strategies are avoided due to their myelosuppressive nature. Therefore those patients are at increased risk of graft versus host disease, and the infusion of a CD34 selected graft would reduce such a risk. The infusion of CD34 selected graft using CliniMACS plus is currently FDA FDA-approved indication for acute myeloid leukemia. However, the use of the Prodigy would streamline the processing, in terms of hands-off procedure, allowing to provision of this product to the patients without strains on the cell therapy lab team. This procedure has been demonstrated safe and effective in several single-center studies and is currently in advanced phase investigation in several studies for malignant and non-malignant conditions.

Official Title

Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS

Quick Facts

Study Start:2025-04-09
Study Completion:2029-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06047886

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:4 Weeks to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. AML in morphologic remission with intermediate/high-risk features or relapsed disease 1 or 2
  2. 2. ALL in morphologic remission with high-risk features or relapsed disease 1 or 2
  3. 3. Lymphoid malignancies in CR or PR (e.g. non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)
  4. 4. Myelodysplastic syndromes with \<=10% blasts
  5. 5. CML in morphologic remission after blast phase or accelerated phase
  6. 6. Primary myelofibrosis with \<=10% blasts \^morphologic remission is defined as \<5% blasts on the bone marrow biopsy. Negative test for donor-specific antibody within 28 days of starting conditioning regimen, or adequate for standard desensitization protocol.
  1. 1. Non-compliant patients.
  2. 2. No appropriate caregivers identified.
  3. 3. Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
  4. 4. Patients with known allergy to DMSO.
  5. 5. Pregnant or breastfeeding women

Contacts and Locations

Study Contact

Antonio Di Stasi, M.D.
CONTACT
205-934-2636
adistasi@uab.edu
Chowdury Nazma
CONTACT
nazma@uab.edu

Study Locations (Sites)

University of Alabama at Birmingham
Birmingham, Alabama, 35294-3300
United States

Collaborators and Investigators

Sponsor: University of Alabama at Birmingham

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 Date2025-04-09
Study Completion Date2029-12

Study Record Updates

Study Start Date2025-04-09
Study Completion Date2029-12

Terms related to this study

Keywords Provided by Researchers

  • hematologic malignancies
  • graft failure

Additional Relevant MeSH Terms

  • AML
  • ALL
  • Lymphoid Malignancies
  • Myelodysplastic Syndromes
  • CML
  • Primary Myelofibrosis