Overview

Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Status:
Recruiting

Trial end date:
2025-06-30

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Peking University People's Hospital

Criteria

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.