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NCT06047886 · ClinicalTrials.gov registry record · Phase 1
UAB 2419-CD34 Selection Using the Automated CliniMACS Prodigy
A Phase 1 study of Myelodysplastic Syndromes and Primary Myelofibrosis, sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT06047886: Recruiting Phase 1 study of Myelodysplastic Syndromes and Primary Myelofibrosis, sponsored by University of Alabama at Birmingham.
NCT06047886 is a Phase 1 study of Myelodysplastic Syndromes and Primary Myelofibrosis that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 50 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06047886, a Phase 1 study of Myelodysplastic Syndromes and Primary Myelofibrosis, is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Incidence of severe (grade III-IV) acute GVHD \<=25% at 100 days
Conditions Studied
Interventions
- DRUG Infusion of CD34 selected hematopoietic stem cells
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2025-04-22 |
| Est. Completion | 2029-12 |
| Phase | Phase 1 |
What NCT06047886 shows while recruiting
NCT06047886 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (82% lower).
The record links to 6 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention - of which Infusion of CD34 selected hematopoietic stem cells is the first listed.
NCT06047886 reports a single indexed study location in Alabama.
Frequently Asked Questions
What is clinical trial NCT06047886 about?
NCT06047886 is a clinical study titled "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 a...
What is the current status of trial NCT06047886?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2025-04-22. Estimated completion is 2029-12.
What conditions does trial NCT06047886 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Primary Myelofibrosis, AML, ALL, CML.
What interventions are being tested in trial NCT06047886?
The interventions under investigation include: Infusion of CD34 selected hematopoietic stem cells (DRUG).
Who is sponsoring clinical trial NCT06047886?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06047886 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06047886's enrollment target sits among peer trials
50 84th of 173 higher than 86 of 173 other Myelodysplastic Syndromes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndromes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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