Interferon-α to Prevent Relapse in TP53-Mutant Leukemia After Stem Cell Transplant
Tests interferon-α in people with TP53-mutant AML or MDS after transplant.
Plain-language title generated from the registry record
Registry title: IFN-α in Relapse Prevention.
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12-65 with MDS or AML with a TP53 mutation who had a first donor stem cell transplant and tested negative for residual disease within 2 months afterwards.
- Age
- 12 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Myelodysplastic syndrome (MDS), or acute myeloid leukemia (AML) with a TP53 mutation, with any remission status. Minimal residual disease must be negative by flow cytometry within 2 months after the first allogeneic stem cell transplant.
- Earlier treatment
- Must have had a first allogeneic hematopoietic stem cell transplant. No history of severe or uncontrolled graft-versus-host disease (GVHD).
- Biomarker or test result
- TP53 mutation. Minimal residual disease (MRD) negative by flow cytometry within 2 months after transplant.
Main reasons for not taking part
- Severe heart, kidney or liver problems
- Another cancer that needs treatment
- Brain dysfunction or severe mental illness that prevents following the study
- Severe acute allergic reaction (anaphylaxis)
- Severe life-threatening infection that is not under control
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 65 years old?
Source: NCT07449286, who can take part
Where in China
- Peking University People's Hospital, Peking University Institute of HematologyBeijing, ChinaContact: Yu WangNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT07449286
- Record updated
- 4 March 2026
- Original description
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).Read full original descriptionShow less
A Multicenter Study on the Effect of Interferon-α in Patients With TP53-Mutant Myeloid Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation
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).
Inclusion: 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: 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; clinically uncontrolled severe life-threatening infections; patients who are unable to complete the necessary treatment plan and follow-up observation; patients with severe acute anaphylaxis; patients enrolled in other clinical trials; other reasons considered by the investigator to be inappropriate for clinical trial participants.