Actively Recruiting

Phase 1
Age: 4Weeks - 75Years
All Genders
NCT06047886

UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

Led by University of Alabama at Birmingham · Updated on 2026-04-13

50

Participants Needed

1

Research Sites

240 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

Who Can Participate

Age: 4Weeks - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • AML in morphologic remission with intermediate/high-risk features or relapsed disease 1 or 2
  • ALL in morphologic remission with high-risk features or relapsed disease 1 or 2
  • Lymphoid malignancies in complete or partial remission (e.g., non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)
  • Myelodysplastic syndromes with 10% or fewer blasts
  • CML in morphologic remission after blast or accelerated phase
  • Primary myelofibrosis with 10% or fewer blasts
  • Morphologic remission defined as fewer than 5% blasts on bone marrow biopsy
  • Negative test for donor-specific antibody within 28 days before starting conditioning, or adequate for standard desensitization protocol
Not Eligible

You will not qualify if you...

  • Non-compliant patients
  • No appropriate caregivers identified
  • Uncontrolled medical or psychiatric disorders that may prevent study participation (attending physician discretion)
  • Known allergy to DMSO
  • Pregnant or breastfeeding women

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294-3300

Actively Recruiting

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Research Team

A

Antonio Di Stasi, M.D.

CONTACT

C

Chowdury Nazma

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy | DecenTrialz