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NCT05800210 · ClinicalTrials.gov registry record · Phase 2
Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05800210: Recruiting Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by University of Florida.
NCT05800210 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by University of Florida. The registered enrollment target is 20 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05800210, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will assess the safety, efficacy, and feasibility of ⍺/β CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndrome (MDS), chronic myeloid leukemia (CML) and lymphoma. Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β CD3+ T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.
Primary Outcome
Compare the incidence of grade II to IV aGVHD following allogeneic stem cell trasplantation utilizing α/β CD3+ T-cell and CD19+ B-cell depletion compared to historical controls by day +100
Conditions Studied
Interventions
- DEVICE Miltenyi CliniMACS Prodigy ® system
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-05-03 |
| Est. Completion | 2027-05 |
| Phase | Phase 2 |
What NCT05800210 shows while recruiting
NCT05800210 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (83% lower).
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Miltenyi CliniMACS Prodigy ® system is the first listed.
NCT05800210 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05800210 about?
NCT05800210 is a clinical study titled "Alpha/Beta T Cell and CD19+ B Cell Depletion in Allogeneic Stem Cell Transplantation in Patients With Malignant Diseases". This study will assess the safety, efficacy, and feasibility of ⍺/β CD3+ T-cell and CD19+ B-cell depletion in allogeneic stem cell transplantation in patients with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), juvenile myelomonocytic leukemia (JMML), high risk myelodysplastic syndr...
What is the current status of trial NCT05800210?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2024-05-03. Estimated completion is 2027-05.
What conditions does trial NCT05800210 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes, Acute Lymphoblastic Leukemia, Lymphoma, Non-Hodgkin, Chronic Myeloid Leukemia.
What interventions are being tested in trial NCT05800210?
The interventions under investigation include: Miltenyi CliniMACS Prodigy ® system (DEVICE).
Who is sponsoring clinical trial NCT05800210?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05800210 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05800210's enrollment target sits among peer trials
20 246th of 306 higher than 50 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia 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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