Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Study Overview
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Brief Summary
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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
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Interferon-α for Preventing Relapse in TP53+ Myeloid Malignancy Post Allo-HSCT

Conditions
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Myeloid Leukemia, Myelodysplastic Syndromes

Intervention / Treatment
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* Drug: IFN-Α


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Myelodysplastic syndrome (MDS) diagnosed according to the 2022 International Consensus Classification of Myeloid Neoplasms and Acute Leukemia (2022ICC) criteria, acute myeloid leukemia (AML) with TP53 mutation (unrestricted remission status), minimal residual disease (MRD) monitored by flow cytometry within 2 months after receiving the first allogeneic hematopoietic stem cell transplantation Negative patients Male or female, aged 12-65 years Karnofsky score >60, estimated survival time >3 months No history of severe graft-versus-host disease (GVHD), uncontrolled GVHD, or severe systemic organ dysfunction: Absolute neutrophil count (ANC) greater than 0.5×109/L Creatinine < 1.5mg/dL Cardiac ejection index >55% Signed informed consent. Exclusion Criteria: severe cardiac, renal, or liver dysfunction combined with other malignant tumors requiring treatment inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness patients who are unable to complete the necessary treatment plan and follow-up observation patients with severe acute anaphylaxis clinically uncontrolled severe life-threatening infections patients enrolled in other clinical trials other reasons considered by the investigator to be inappropriate for clinical trial participants.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IFN-α application in TP53+ myeloid malignancy<br> | Drug: IFN-Α<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of relapse | Disease relapse was defined as blasts ≥ 5% post transplantation. | 1 year post HSCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of positive minimal residual disease post allo-HSCT | Positive MRD was defined as leukemia-associated immunophenotyping (LAIPs) by flow cytometry. | 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. | aGvHD within 100 days and cCvHD within 1 year | 
| The incidence of non-relapse mortality | The incidence of non-relapse mortality | 1 year post HSCT. | 
| The probability of progression free survival | Survival without disease progression | 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. | 1 year post HSCT. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IFN-α, Preventing relapse, allo-HSCT