IFN-α in Relapse Prevention. (NCT07449286) | Clinical Trial Compass
Not Yet RecruitingPhase 2
IFN-α in Relapse Prevention.
China100 participantsStarted 2026-03-01
Plain-language 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).
Who can participate
Age range12 Years – 65 Years
SexALL
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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
✓. 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