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NCT06047886 | RECRUITING | AML

UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Antonio di Stasi

Brief Summary:

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.

Condition or disease

AML

ALL

Lymphoid Malignancies

Myelodysplastic Syndromes

CML

Primary Myelofibrosis

Intervention/treatment

Infusion of CD34 selected hematopoietic stem cells

Phase

PHASE1

Detailed Description:

Patients eligible to be treated on this status are 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 (e.g. marrow cellularity reduced per age and/or dropping donor chimerism with cytopenias and/or platelets or red blood cells transfusion requirement).

Study Type : INTERVENTIONAL
Estimated Enrollment : 50 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS
Actual Study Start Date : 2025-04-22
Estimated Primary Completion Date : 2029-10
Estimated Study Completion Date : 2029-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 4 Weeks to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. AML in morphologic remission with intermediate/high-risk features or relapsed disease 1 or 2
  • 2. ALL in morphologic remission with high-risk features or relapsed disease 1 or 2
  • 3. Lymphoid malignancies in CR or PR (e.g. non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)
  • 4. Myelodysplastic syndromes with \<=10% blasts
  • 5. CML in morphologic remission after blast phase or accelerated phase
  • 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.
Exclusion Criteria
  • 1. Non-compliant patients.
  • 2. No appropriate caregivers identified.
  • 3. Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
  • 4. Patients with known allergy to DMSO.
  • 5. Pregnant or breastfeeding women
UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

Location Details

NCT06047886

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How to Participate

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Locations

RECRUITING

United States, Albama

University of Alabama at Birmingham

Birmingham, Albama, United States, 35294-3300