Actively Recruiting

Phase 2
Age: 0 - 65Years
All Genders
NCT03579875

Alpha/Beta TCD HCT in Patients With Inherited BMF Disorders

Led by Masonic Cancer Center, University of Minnesota · Updated on 2026-01-30

48

Participants Needed

1

Research Sites

529 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Alpha/Beta TCD HCT in Patients With Inherited BMF Disorders

Who Can Participate

Age: 0 - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Fanconi anemia (FA) and age under 65 years
  • Presence of severe aplastic anemia, myelodysplastic features, high risk genotype, or immunodeficiency with recurrent infections for FA patients
  • Karnofsky performance status \u2265 70% if 16 years or older or Lansky play score \u2265 50% if under 16 years
  • Adequate lung, heart, and liver function
  • Voluntary written consent (and minor assent if appropriate) before study procedures
  • Diagnosis of telomere biology disorder (TBD) and age under 70 years
  • Presence of severe aplastic anemia or myelodysplastic features for TBD patients
  • Donor matches including HLA-A, B, DRB1 matched sibling or related donor, mismatched related donor, or 7-8/8 HLA matched unrelated donor
  • Donor age at least 12 years and weight at least 40 kilograms
  • Donor willing and able to undergo mobilized peripheral blood apheresis
  • Donor in general good health with adequate organ function (hematologic, liver, and kidney)
  • Donor infectious disease screening negative for HIV, hepatitis B and C, and other infections
  • Female donors of childbearing potential with negative pregnancy test prior to mobilization
  • Voluntary written consent from donors before research procedures
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women; females of childbearing potential must have a negative pregnancy test within 14 days before study
  • Active, uncontrolled infection within 1 week before starting study therapy
  • Malignant solid tumor cancer within previous 2 years

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

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Research Team

M

Margaret MacMillan, MD, Msc, FRCPC

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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Alpha/Beta TCD HCT in Patients With Inherited BMF Disorders | DecenTrialz