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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 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.

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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.

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

FieldValue
Enrollment Target 48 participants
Start Date 2018-11-13
Est. Completion 2029-01-05
Phase Phase 2

What the Registry Record Tells You About NCT03579875

The ClinicalTrials.gov registry entry for NCT03579875 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (83% 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 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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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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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