Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Recruiting now · Phase 2

Conditions studied: 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

NCT06130579

Run by

Peking University People's Hospital

People needed

35

Starts

2024-01-01

Expected to finish

2026-06-30

Last updated by the study team

2025-06-03

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

• Deparment of Hematology, Peking University People's Hospital — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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