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Not yet recruiting NCT07449286

IFN-α in Relapse Prevention.

Phase II Interventional Acute Myeloid Leukemia Myelodysplastic Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IFN-α.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes. Basic parameters: 12 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Multicenter Study on the Effect of Interferon-α in Patients With TP53-Mutant Myeloid Malignancy After Allogeneic Hematopoietic Stem Cell Transplantation

Overview

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).

Interventions

  • 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.

Primary outcome measures

  • The incidence of relapse [Time frame: 1 year post HSCT]
Secondary outcome measures (5)
  • The incidence of positive minimal residual disease post allo-HSCT [Time frame: 1 year post HSCT]
  • The incidence of acute and chronic graft versus host disease (GvHD) [Time frame: aGvHD within 100 days and cCvHD within 1 year]
  • The incidence of non-relapse mortality [Time frame: 1 year post HSCT]
  • The probability of progression free survival [Time frame: 1 year post HSCT]
  • The probability of overall survival (OS) [Time frame: 1 year post HSCT]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking University People's Hospital, Peking University Institute of Hematology — Beijing

Identifiers

NCT: NCT07449286 · IFN-α in relapse prevention.

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗