Recruiting
Phase 1

UAB 2419

Sponsor:

University of Alabama at Birmingham

Code:

NCT06047886

Conditions

AML

ALL

Lymphoid Malignancies

Myelodysplastic Syndromes

CML

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

Interventions

Infusion of CD34 selected hematopoietic stem cells

Study Details

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.

Conditions

AML

ALL

Lymphoid Malignancies

Myelodysplastic Syndromes

CML

Study ID

NCT06047886

Start date

Apr 22, 2025

Status verified date

Apr, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Infusion of CD34 selected hematopoietic stem cells

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

Primary outcome measure

  • Severe acute GVHD [ Time Frame: 6 years ]
  • extensive chronic GVHD [ Time Frame: 6 years ]
  • donor chimerism [ Time Frame: 6 years ]
  • Clinical improvement [ Time Frame: 6 years ]

Central Contacts and Locations

Central contacts

Antonio Di Stasi, M.D.

205-934-2636adistasi@uab.edu

Chowdury Nazma

nazma@uab.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294-3300

Contacts

Antonio Di Stasi

12059342636adistasi@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • hematologic malignancies
  • graft failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-04-13.