IFN-α in Relapse Prevention.

Starting soon · Phase 2

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndromes

In brief

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 facts

Study ID: NCT07449286
Run by: Peking University People's Hospital
People needed: 100
Starts: 2026-03-01
Expected to finish: 2027-06-30
Last updated by the study team: 2026-03-04

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Peking University People's Hospital, Peking University Institute of Hematology — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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