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Alpha/Beta TCD HCT in Patients With Inherited BMF Disorders

StatusRecruiting
PhasePhase 2
Started2018-11-13
View on ClinicalTrials.gov ↗

Amendment history

2026-01-29
Study Status v13
Primary completion date2026-01-01→2027-01-01
2025-07-29
Study Status, Conditions, Arms and Interventions, Eligibility v12
InterventionsAlemtuzumab (Drug), Busulfan (Drug), Cyclophosphamide (CY) (Plan 1) (Drug), Cyclophosphamide (CY) (Plan 2) (Drug), Donor mobilized PBSC…→Alemtuzumab (Drug), Busulfan (Drug), Cyclophosphamide (CY) (Plan 1) (Drug), Cyclophosphamide (CY) (Plan 2) (Drug), Donor mobilized PBSC…
Eligibility criteria-12 characters
[...] risk factors: Severe aplastic anemia (SAA) Myelodysplastic syndrome (MDS)features High risk genotype Immunodeficiency associated with history [...] risk factors: Severe aplastic anemia (SAA) Myelodysplastic syndrome (MDS)features Karnofsky performance status ≥ 70% if ≥ 16 years of age or [...]
2025-03-11
Study Status v11
Re-verified, no change to tracked fields
2024-06-04
Study Identification, Study Status, Study Description, Conditions, Arms and Interventions, Eligibility, Contacts/Locations v10
Study arms3→5
InterventionsBusulfan (Drug), Cyclophosphamide (CY) (Plan 1) (Drug), Cyclophosphamide (CY) (Plan 2) (Drug), Donor mobilized PBSC infusion (Device)…→Alemtuzumab (Drug), Busulfan (Drug), Cyclophosphamide (CY) (Plan 1) (Drug), Cyclophosphamide (CY) (Plan 2) (Drug), Donor mobilized PBSC…
Eligibility criteria-371 characters
Patient Selection: Inclusion Criteria: For FA patients: Diagnosis of Fanconi anemia LessAge than <65 years of age Karnofsky performance status of ≥ 70% or, for children < 16 years of age, Lansky Play Score ≥ 50 Presence of at leastHas one of the following risk factors: Severe aplastic anemia (SAA) defined as: Aplastic anemia is defined as having at least one of the following when not receiving growth factors or transfusions: platelet count <20 x 109/L absolute neutrophil count of <5 x 108/L hemoglobin <8 g/dL Myelodysplastic syndrome (MDS) or acute leukemia High risk genotype AdequateImmunodef [...] [...]
Study titlerevised
T Cell Receptor αAlpha/βBeta TCD HCT in Patients With FanconiInherited AnemiaBMF Disorders
2023-11-02
Study Status v9
Re-verified, no change to tracked fields
Show 8 earlier versions
2022-11-02
Study Status v8
Primary completion date2026-02→2026-01-01
Completion date2029-02→2029-01-05
2021-05-20
Study Status, Contacts/Locations v7
Study sitescontacts updated at 1 of 1 site
2020-12-01
Study Status, Arms and Interventions, Eligibility v6
Study arms2→3
InterventionsCyclophosphamide (CY) (Plan 1) (Drug), Cyclophosphamide (CY) (Plan 2) (Drug), Donor mobilized PBSC infusion (Device), Fludarabine (FLU)…→Busulfan (Drug), Cyclophosphamide (CY) (Plan 1) (Drug), Cyclophosphamide (CY) (Plan 2) (Drug), Donor mobilized PBSC infusion (Device)…
Eligibility criteria-24 characters
[...] % or, for children < 16 years of age, Lansky Play Score ≥ 50 - refer to Appendix III Presence of at least one of the following risk factors: Sev [...]
2020-03-16
Study Status v5
Re-verified, no change to tracked fields
2019-03-15
Study Status, Arms and Interventions v4
InterventionsCyclophosphamide (CY) (Plan 1) (Drug), Cyclophosphamide (CY) (Plan 2) (Drug), Donor mobilized PBSC infusion (Device), Fludarabine (FLU)…→Cyclophosphamide (CY) (Plan 1) (Drug), Cyclophosphamide (CY) (Plan 2) (Drug), Donor mobilized PBSC infusion (Device), Fludarabine (FLU)…
2018-11-26
Withheld→Recruiting Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
Trial statusWithheld→Recruiting
Primary completion datenot stated→2026-02
Completion datenot stated→2029-02
Start datenot stated→2018-11-13
Lead sponsor[Redacted]→Masonic Cancer Center, University of Minnesota
Study title-6 characters
[TrialT ofCell deviceReceptor thatα/β isTCD notHCT approvedin orPatients clearedWith byFanconi the U.S. FDA]Anemia
2018-10-01
2 amendments v1-v2
2 re-verifications since 2018-09-25, no change to tracked fields
2018-07-06
Original filing
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.
Trial Details
NCT Number NCT03579875
Lead Sponsor Masonic Cancer Center, University of Minnesota
Conditions Fanconi Anemia, Severe Aplastic Anemia, Myelodysplastic Syndromes, T Cell Receptor Alpha/Beta Depletion, Telomere Biology Disorder, Bone Marrow Failure, Dyskeratosis Congenita, Telomere Biology Disorders
Enrollment 48 participants
Start Date 2018-11-13
Primary Completion 2027-01-01 (estimated)
Study Completion 2029-01-05 (estimated)
Updated on ClinicalTrials.gov 2026-01-30