Clinical trial · Interventional
IFN-α in Relapse Prevention.
A Multicenter Study on the Effect of Interferon-α in Patients With TP53-Mutant Myeloid Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IFN-α | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IFN-α application in TP53+ myeloid malignancy
- interventionNames
- Drug: IFN-α
Primary outcomes (1)
- measure
- The incidence of relapse
- timeFrame
- 1 year post HSCT
- description
- Disease relapse was defined as blasts ≥ 5% post transplantation
Secondary outcomes (5)
- measure
- The incidence of positive minimal residual disease post allo-HSCT
- timeFrame
- 1 year post HSCT
- description
- Positive MRD was defined as leukemia-associated immunophenotyping (LAIPs) by flow cytometry
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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 2. Male or female, aged 12-65 years 3. Karnofsky score \>60, estimated survival time \>3 months 4. No history of severe graft-versus-host disease (GVHD), uncontrolled GVHD, or severe systemic organ dysfunction: 1. Absolute neutrophil count (ANC) greater than 0.5×109/L 2. Creatinine \< 1.5mg/dL 3. Cardiac ejection index \>55% 5. Signed informed consent. Exclusion Criteria: 1. severe cardiac, renal, or liver dysfunction 2. combined with other malignant tumors requiring treatment 3. inability to understand or adhere to the study protocol due to clinical symptoms of brain dysfunction or severe mental illness 4. patients who are unable to complete the necessary treatment plan and follow-up observation 5. patients with severe acute anaphylaxis 6. clinically uncontrolled severe life-threatening infections 7. patients enrolled in other clinical trials 8. other reasons considered by the investigator to be inappropriate for clinical trial participants.
References
Publications (0)
Data not yet available