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NCT Number: NCT06047886

UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

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.

Recruiting

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Key information

Age range

4 week–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294-3300, United States

Location status: Recruiting

Location contact

Antonio Di Stasi

CONTACT

[email protected]

12059342636

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 CR or PR (e.g. non-Hodgkin's lymphoma, prolymphocytic leukemia, CLL)
  • Myelodysplastic syndromes with <=10% blasts
  • CML in morphologic remission after blast phase or accelerated phase
  • 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

  • Non-compliant patients.
  • No appropriate caregivers identified.
  • Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
  • Patients with known allergy to DMSO.
  • Pregnant or breastfeeding women

Treatment and study plan

Infusion of CD34 selected hematopoietic stem cells

Drug

CD34 stem cell isolation and infusion to reduce alloreactive complication of stem cell infusion

Primary outcomes

  1. Severe acute GVHD

    Time frame: 6 years

    Incidence of severe (grade III-IV) acute GVHD <=25% at 100 days

  2. extensive chronic GVHD

    Time frame: 6 years

    Incidence of extensive chronic GVHD <=10% at one year.

  3. donor chimerism

    Time frame: 6 years

    Improvement of donor chimerism by >=15%

  4. Clinical improvement

    Time frame: 6 years

    Clinical improvement, defined as an increase of blood counts with transfusion independence if anemia or thrombocytopenia or freedom for infections if reduced leukocytes

Secondary outcomes

  1. Non-relapse mortality

    Time frame: 6 years

    Rate of one-year non-relapse mortality (NRM).

  2. Disease relapse

    Time frame: 6 years

    Rate of one-year relapse

  3. overall survival

    Time frame: 6 years

    Rate of one-year overall survival (OS).

  4. Absolute neutrophil count

    Time frame: 6 years

    ANC engraftment or increase

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Di Stasi, M.D.

CONTACT

[email protected]

205-934-2636

Chowdury Nazma

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 21, 2023
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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