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NCT06412497 · ClinicalTrials.gov registry record · Phase 2
MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.
A Phase 2 study of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria, sponsored by Masonic Cancer Center, University of Minnesota.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT06412497: Recruiting Phase 2 study of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria, sponsored by Masonic Cancer Center, University of Minnesota.
NCT06412497 is a Phase 2 study of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria that is actively recruiting participants, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 60 participants, below the 123-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target (51% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06412497, a Phase 2 study of Severe Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria, is actively recruiting participants, sponsored by Masonic Cancer Center, University of Minnesota.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
A phase II trial of a reduced intensity conditioned (RIC) allogeneic hematopoietic cell transplant (HCT) with post-transplant cyclophosphamide (PTCy) for idiopathic severe aplastic anemia (SAA), paroxysmal nocturnal hemoglobinuria (PNH), acquired pure red cell aplasia (aPRCA), or acquired amegakaryocytic thrombocytopenia (aAT) utilizing population pharmacokinetic (popPK)-guided individual dosing of pre-transplant conditioning and differential dosing of low dose total body irradiation based on age, presence of myelodysplasia and/or clonal hematopoiesis.
Primary Outcome
Incidence of grade 3-4 acute graft-versus host disease (GvHD) at 1 year post HCT.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Rituximab
- RADIATION Total Body Irradiation
- DRUG Rabbit ATG
Study Locations (1)
Minnesota
- University of Minnesota Masonic Cancer Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2024-06-05 |
| Est. Completion | 2036-05-01 |
| Phase | Phase 2 |
What NCT06412497 shows while recruiting
NCT06412497 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 123-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target (51% lower).
The record links to 4 conditions, with Severe Aplastic Anemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06412497 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06412497 about?
NCT06412497 is a clinical study titled "MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.". A phase II trial of a reduced intensity conditioned (RIC) allogeneic hematopoietic cell transplant (HCT) with post-transplant cyclophosphamide (PTCy) for idiopathic severe aplastic anemia (SAA), paroxysmal nocturnal hemoglobinuria (PNH), acquired pure red cell aplasia (aPRCA), or acquired amegakaryo...
What is the current status of trial NCT06412497?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2024-06-05. Estimated completion is 2036-05-01.
What conditions does trial NCT06412497 study?
This clinical trial studies the following conditions: Severe Aplastic Anemia, Paroxysmal Nocturnal Hemoglobinuria, Acquired Amegakaryocytic Thrombocytopenia, Acquired Pure Red Cell Aplasia.
What interventions are being tested in trial NCT06412497?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Rituximab (DRUG), Total Body Irradiation (RADIATION), Rabbit ATG (DRUG).
Who is sponsoring clinical trial NCT06412497?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06412497 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 NCT06412497's enrollment target sits among peer trials
60 7th of 16 higher than 9 of 16 other Severe Aplastic Anemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Severe Aplastic Anemia 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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