Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Peking University People's Hospital (Other)
Overall Status
Not yet recruiting ID

Study Details

Study Description

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 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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Anticipated Enrollment :
35 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Interferon-α for Preventing Relapse in TP53+ Myeloid Malignancy Post Allo-HSCT
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: IFN-α application in TP53+ myeloid malignancy

Drug: IFN-Α
Leukemia-associated immunophenotyping (LAIPs) was performed by flow cytometry at +1 month and +2 month after HSCT. If MRD was negative on two consecutive flow cytometry assays, interferon-α prophylaxis was initiated on day +75 after transplantation, and cyclosporine was tapered on day +100 after transplantation. The dose of interferon-α was 3 million units/time, subcutaneously injected twice a week. Cycles were given every 4 weeks until hematologic relapse or up to 6 cycles.

Outcome Measures

Primary Outcome Measures

  1. The incidence of relapse [1 year post HSCT]

    Disease relapse was defined as blasts ≥ 5% post transplantation.

Secondary Outcome Measures

  1. The incidence of positive minimal residual disease post allo-HSCT [1 year post HSCT]

    Positive MRD was defined as leukemia-associated immunophenotyping (LAIPs) by flow cytometry.

  2. The incidence of acute and chronic graft versus host disease (GvHD) [aGvHD within 100 days and cCvHD within 1 year]

    The severity of acute GvHD (aGvHD) and chronic GvHD (cGvHD) was evaluated according to standard criteria.

  3. The incidence of non-relapse mortality [1 year post HSCT.]

    The incidence of non-relapse mortality

  4. The probability of progression free survival [1 year post HSCT.]

    Survival without disease progression

  5. The probability of overall survival (OS) [1 year post HSCT.]

    OS was defined as the time from transplantation to death from any cause or to the last follow-up.

Eligibility Criteria


Ages Eligible for Study:
12 Years to 65 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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:

  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 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.

Contacts and Locations


No locations specified.

Sponsors and Collaborators

  • Peking University People's Hospital


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Xiao-Jun Huang, Professor, Peking University People's Hospital Identifier:
Other Study ID Numbers:
  • IFN-α for preventing relapse
First Posted:
Nov 14, 2023
Last Update Posted:
Nov 18, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Keywords provided by Xiao-Jun Huang, Professor, Peking University People's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 18, 2023