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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IFN-α application in TP53+ myeloid malignancy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of relapse | Disease relapse was defined as blasts ≥ 5% post transplantation. | 1 year post HSCT |
| 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) |
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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:
Signed informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu Wang | Contact | 86-13552647384 | ywyw3172@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deparment of Hematology, Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
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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. |
| D006425 |
| Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |