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NCT03579875 · ClinicalTrials.gov registry record · Phase 2
Alpha/Beta TCD HCT in Patients With Inherited BMF Disorders
A Phase 2 study of Myelodysplastic Syndromes and Severe Aplastic Anemia, sponsored by Masonic Cancer Center, University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT03579875: Recruiting Phase 2 study of Myelodysplastic Syndromes and Severe Aplastic Anemia, sponsored by Masonic Cancer Center, University of Minnesota.
NCT03579875 is a Phase 2 study of Myelodysplastic Syndromes and Severe Aplastic Anemia that is actively recruiting participants, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 48 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes 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
NCT03579875, a Phase 2 study of Myelodysplastic Syndromes and Severe Aplastic Anemia, is actively recruiting participants, sponsored by Masonic Cancer Center, University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase II trial of T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation in patients with inherited bone marrow failure (BMF) disorders to eliminate the need for routine graft-versus-host disease (GVHD) immune suppression leading to earlier immune recovery and potentially a reduction in the risk of severe infections after transplantation.
Primary Outcome
incidence of grade II-IV acute graft versus host disease (GVHD)
Conditions Studied
Interventions
- DRUG Total Body Irradiation (TBI) (Plan 1)
- DRUG Cyclophosphamide (CY) (Plan 1)
- DRUG Fludarabine (FLU)
- DRUG Methylprednisolone (MP)
- DEVICE Donor mobilized PBSC infusion
Study Locations (1)
Minnesota
- Masonic Cancer Center at University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2018-11-13 |
| Est. Completion | 2029-01-05 |
| Phase | Phase 2 |
What NCT03579875 shows while recruiting
NCT03579875 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (83% lower).
The record links to 8 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 5 interventions - of which Total Body Irradiation (TBI) (Plan 1) is the first listed.
NCT03579875 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03579875 about?
NCT03579875 is a clinical study titled "Alpha/Beta TCD HCT in Patients With Inherited BMF Disorders". This is a phase II trial of T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation in patients with inherited bone marrow failure (BMF) disorders to eliminate the need for routine graft-versus-host disease (GVHD) immune suppression leading to earlier immune ...
What is the current status of trial NCT03579875?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2018-11-13. Estimated completion is 2029-01-05.
What conditions does trial NCT03579875 study?
This clinical trial studies the following conditions: Myelodysplastic Syndromes, Severe Aplastic Anemia, Fanconi Anemia, Dyskeratosis Congenita, Bone Marrow Failure.
What interventions are being tested in trial NCT03579875?
The interventions under investigation include: Total Body Irradiation (TBI) (Plan 1) (DRUG), Cyclophosphamide (CY) (Plan 1) (DRUG), Fludarabine (FLU) (DRUG), Methylprednisolone (MP) (DRUG), Donor mobilized PBSC infusion (DEVICE).
Who is sponsoring clinical trial NCT03579875?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03579875 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03579875's enrollment target sits among peer trials
48 91st of 173 higher than 82 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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