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RECRUITING
NCT06130579
PHASE2

Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

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: Interferon-α for Preventing Relapse in TP53+ Myeloid Malignancy Post Allo-HSCT

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2024-01-01

Completion Date

2026-06-30

Last Updated

2025-06-03

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)

Deparment of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, China