UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT06047886
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
4 Weeks - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Infusion of CD34 selected hematopoietic stem cells — DRUG
    CD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion

Study Details

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.

Key Dates

Start date
Apr 22, 2025
Status verified
Apr 2026
Primary completion
Oct 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment population
    Patients status post allogeneic hematopoietic stem cell transplantation for a neoplastic hematologic disorder with the need of a CD34 selected stem cell boost for graft failure or low graft function will receive a CD34 selected hematopoietic stem cell infusion with or without preceding conditioning. Fludarabine 25 mg/mq day 1 - 5 + 2 Gray Total body irradiation depending on clinician's discretion (with the addition of cyclophosphamide 14.5 mg/kg for two doses for haploidentical or matched unrelated donor with at least one major HLA mismatch). Recommendation to use a conditioning regimen include complete loss of donor chimerism, trilineage cytopenias.

Primary Outcome Measure

Severe acute GVHD [ Time Frame: 6 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-3300
Antonio Di Stasi
[email protected]
12059342636

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