IFN-α in Relapse Prevention.

Sponsor
Peking University People's Hospital
Study ID
NCT07449286
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • IFN-α — DRUG
    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.

Study Details

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).

Key Dates

First listed
Mar 4, 2026
Start date
Mar 1, 2026
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: IFN-α application in TP53+ myeloid malignancy

Primary Outcome Measure

The incidence of relapse [ Time Frame: 1 year post HSCT ]

Central Contacts

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