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NOT YET RECRUITING
NCT07449286
PHASE2

IFN-α in Relapse Prevention.

Sponsor: Peking University People's Hospital

View on ClinicalTrials.gov

Summary

To investigate the efficacy of interferon-α prophylaxis in patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) with TP53 mutation who were negative for minimal residual disease (MRD) by flow cytometry within 2 months after allogeneic hematopoietic stem cell transplantation. To explore the efficacy of interferon-α in reducing the relapse rate of AML/MDS patients with TP53 mutation after allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Official title: A Multicenter Study on the Effect of Interferon-α in Patients With TP53-Mutant Myeloid Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-03-01

Completion Date

2027-06-30

Last Updated

2026-03-04

Healthy Volunteers

No

Interventions

DRUG

IFN-α

Leukemia-associated immunophenotyping (LAIPs) was performed by flow cytometry at +1 month and * 2 month after HSCT. If MRD was negative on two consecutive flow cytometry assays, interferon- α prophylaxis was initiated on day +75 after transplantation, and cyclosporine was tapered on day * 100 after transplantation. The dose of interferon- α was 3 million units/time, subcutaneously injected twice a week. Cycles were given every 4 weeks until hematologic relapse or up to 6 cycles.

Locations (1)

Peking University People's Hospital, Peking University Institute of Hematology

Beijing, Beijing Municipality, China