NCT06047886RecruitingPhase 1
UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy
Feasibility Study of CD34 Selection for GVHD Prophylaxis Using the Automated CliniMACS
Source: ClinicalTrials.gov · Last updated 13 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 14 Sept 2023
- Start date
- 22 Apr 2025
- Primary completion date
- Oct 2029
- Lead sponsor
- University of Alabama at Birmingham
- NCT number
- NCT06047886
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 50
- From 22 Apr 2025 to the primary completion date, Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Uncontrolled medical or psychiatric disorders which may preclude patients to undergo clinical studies (Discretion of the attending physician).
- Patients with known allergy to DMSO.
Other
- Non-compliant patients.
- No appropriate caregivers identified.
- Pregnant or breastfeeding women
Who the study is looking for
- 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.
Age in the registry: 4 weeks to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.