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Interferon-α for Relapse Prevention in TP53+ AML/MDS Post-Transplant
NCT06130579Phase 2
Key facts
- Status
- Recruiting
- Start
- Jan 2024
- Primary completion
- Dec 2025
- Countries
- 1
- Sponsor
- Peking University People's Hospital
- Modality
- Cytokines & Interferons
- Drugs
- interferon alfa
- Conditions
- acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)
01
Overview
Phase 2, open-label, single-arm trial of interferon alfa in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), sponsored by Peking University People's Hospital. Primary endpoint: The incidence of relapse at 1 year. Started Jan 2024; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
IFN-alpha Prophylaxis
Interferon-alpha 3 million units SC twice weekly for up to 6 cycles.
03
Who it enrols
Patients aged 12-65 with TP53+ AML or MDS who are MRD negative by flow cytometry within 2 months post-allo-HSCT.
04
Endpoints
Primary
The incidence of relapse
Secondary
The incidence of positive minimal residual disease post allo-HSCT
The incidence of acute graft versus host disease
The incidence of chronic graft versus host disease
The incidence of non-relapse mortality
The probability of progression free survival
The probability of overall survival
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