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NCT Number: NCT06130579

Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

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).

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Key information

Conditions

Myeloid Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Deparment of Hematology, Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Xiaojun Huang, doctor

CONTACT

[email protected]

8601088326666

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

IFN-Α

Drug

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.

Primary outcomes

  1. The incidence of relapse

    Time frame: 1 year post HSCT

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

Secondary outcomes

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

    Time frame: 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)

    Time frame: 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

    Time frame: 1 year post HSCT.

    The incidence of non-relapse mortality

  4. The probability of progression free survival

    Time frame: 1 year post HSCT.

    Survival without disease progression

  5. The probability of overall survival (OS)

    Time frame: 1 year post HSCT.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Wang

CONTACT

[email protected]

86-13552647384

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Interferon-α for Preventing Relapse in TP53+ Myeloid Malignancy Post Allo-HSCT

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 14, 2023
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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