NCT06047886 UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy
| NCT ID | NCT06047886 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Alabama at Birmingham |
| Condition | AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-04-22 |
| Primary Completion | 2029-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2025-04-22 with a primary completion date of 2029-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06047886 clinical trial?
This trial is open to participants of all sexes, aged 4 Weeks or older, up to 75 Years, studying AML. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06047886 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06047886 currently recruiting?
Yes, NCT06047886 is actively recruiting participants. Contact the research team at adistasi@uab.edu for enrollment information.
Where is the NCT06047886 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06047886 clinical trial?
NCT06047886 is sponsored by University of Alabama at Birmingham. The trial plans to enroll 50 participants.