Status:
RECRUITING
Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
Lead Sponsor:
Peking University People's Hospital
Conditions:
Myeloid Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
12-65 years
Phase:
PHASE2
Brief 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 disea...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06130579
Start Date
January 1 2024
End Date
June 30 2026
Last Update
June 3 2025
Active Locations (1)
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1
Deparment of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044