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AMLPhase 1NCT06047886

UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy

A Phase 1 study testing Infusion of CD34 selected hematopoietic stem cells in people with AML and ALL, run by University of Alabama at Birmingham at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 weeks to 75 years
Conditions the study is for
AML, ALL, Lymphoid Malignancies
What is being tested?
Infusion of CD34 selected hematopoietic stem cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
22 Apr 2025to Dec 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 weeks to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Antonio Di Stasi, M.D. contact

205-934-2636

adistasi@uab.edu

Chowdury Nazma contact

nazma@uab.edu

United States1 site, 1 recruiting

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3300

    Antonio Di Stasi, 12059342636, adistasi@uabmc.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the 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).

Being tested
Infusion of CD34 selected hematopoietic stem cells
Keywords
hematologic malignancies, graft failure
Medical subject headings
Myelodysplastic Syndromes, Primary Myelofibrosis, Hematologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Infusion of CD34 selected hematopoietic stem cellsDrug

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

Study groups in NCT06047886
Study groupRoleWhat they receive
Treatment populationExperimentalPatients 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.
Receives: Drug: Infusion of CD34 selected hematopoietic stem cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severe acute GVHD

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

    Measured: 6 years

  2. extensive chronic GVHD

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

    Measured: 6 years

  3. donor chimerism

    Improvement of donor chimerism by >=15%

    Measured: 6 years

  4. Clinical improvement

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

    Measured: 6 years

Secondary outcomes (4)

  1. Non-relapse mortality

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

    Measured: 6 years

  2. Disease relapse

    Rate of one-year relapse

    Measured: 6 years

  3. overall survival

    Rate of one-year overall survival (OS).

    Measured: 6 years

  4. Absolute neutrophil count

    ANC engraftment or increase

    Measured: 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start22 Apr 2025
  3. Primary completionOct 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Feasibility study of CD34 selection for graft versus host disease (GVHD) Prophylaxis using the automated CliniMACS Prodigy Device.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047886
Sponsor's protocol ID
IDE29384
Status last verified
Apr 2026
First submitted
14 Sep 2023
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Locatelli F, Lucarelli B, Merli P. Current and future approaches to treat graft failure after allogeneic hematopoietic stem cell transplantation. Expert Opin Pharmacother. 2014 Jan;15(1):23-36. doi: 10.1517/14656566.2014.852537. Epub 2013 Oct 25.

    PubMed 24156789

  • Pasquini MC, Devine S, Mendizabal A, Baden LR, Wingard JR, Lazarus HM, Appelbaum FR, Keever-Taylor CA, Horowitz MM, Carter S, O'Reilly RJ, Soiffer RJ. Comparative outcomes of donor graft CD34+ selection and immune suppressive therapy as graft-versus-host disease prophylaxis for patients with acute myeloid leukemia in complete remission undergoing HLA-matched sibling allogeneic hematopoietic cell transplantation. J Clin Oncol. 2012 Sep 10;30(26):3194-201. doi: 10.1200/JCO.2012.41.7071. Epub 2012 Aug 6.

    PubMed 22869882

  • Roldan E, Perales MA, Barba P. Allogeneic Stem Cell Transplantation with CD34+ Cell Selection. Clin Hematol Int. 2019 Sep 1;1(3):154-160. doi: 10.2991/chi.d.190613.001. eCollection 2019 Sep.

    PubMed 34595425

  • Spohn G, Wiercinska E, Karpova D, Bunos M, Hummer C, Wingenfeld E, Sorg N, Poppe C, Huppert V, Stuth J, Reck K, Essl M, Seifried E, Bonig H. Automated CD34+ cell isolation of peripheral blood stem cell apheresis product. Cytotherapy. 2015 Oct;17(10):1465-71. doi: 10.1016/j.jcyt.2015.04.005. Epub 2015 May 14.

    PubMed 25981397

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Infusion of CD34 selected hematopoietic stem cells in people with AML and ALL, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antonio Di Stasi, M.D. (205-934-2636, adistasi@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severe acute GVHD (time frame: 6 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06047886, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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