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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 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.

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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.

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

FieldValue
Enrollment Target 60 participants
Start Date 2024-06-05
Est. Completion 2036-05-01
Phase Phase 2

What the Registry Record Tells You About NCT06412497

The ClinicalTrials.gov registry entry for NCT06412497 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 123-participant average among 16 other Severe Aplastic Anemia trials with a reported enrollment target (51% lower). The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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