Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Last updated: May 28, 2025
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

White Cell Disorders

Hematologic Cancer

Treatment

IFN-Α

Clinical Study ID

NCT06130579
IFN-α for preventing relapse
  • Ages 12-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Myelodysplastic syndrome (MDS) diagnosed according to the 2022 InternationalConsensus 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 afterreceiving the first allogeneic hematopoietic stem cell transplantation Negativepatients

  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 severesystemic organ dysfunction:

  5. Absolute neutrophil count (ANC) greater than 0.5×109/L

  6. Creatinine < 1.5mg/dL

  7. Cardiac ejection index >55%

  8. Signed informed consent.

Exclusion

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 ofbrain dysfunction or severe mental illness

  4. patients who are unable to complete the necessary treatment plan and follow-upobservation

  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 trialparticipants.

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: IFN-Α
Phase: 2
Study Start date:
January 01, 2024
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Deparment of Hematology, Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

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