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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
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.
Deparment of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe incidence of relapse
Disease relapse was defined as blasts ≥ 5% post transplantation.
Time frame: 1 year post HSCT
The incidence of positive minimal residual disease post allo-HSCT
Positive MRD was defined as leukemia-associated immunophenotyping (LAIPs) by flow cytometry.
Time frame: 1 year post HSCT
The incidence of acute and chronic graft versus host disease (GvHD)
The severity of acute GvHD (aGvHD) and chronic GvHD (cGvHD) was evaluated according to standard criteria.
Time frame: aGvHD within 100 days and cCvHD within 1 year
The incidence of non-relapse mortality
The incidence of non-relapse mortality
Time frame: 1 year post HSCT.
The probability of progression free survival
Survival without disease progression
Time frame: 1 year post HSCT.
The probability of overall survival (OS)
OS was defined as the time from transplantation to death from any cause or to the last follow-up.
Time frame: 1 year post HSCT.
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