Using interferon-α to prevent relapse in myeloid malignancies after stem cell transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of interferon-α as a preventive treatment for patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) who have a TP53 mutation and are in remission after allogeneic hematopoietic stem cell transplantation (allo-HSCT). The trial focuses on patients who are negative for minimal residual disease (MRD) as determined by flow cytometry within two months post-transplant. The goal is to determine if interferon-α can reduce the relapse rate in this specific patient population.

Why it matters

Who can join: the full rules

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:

   1. Absolute neutrophil count (ANC) greater than 0.5×109/L
   2. Creatinine \< 1.5mg/dL
   3. Cardiac ejection index \>55%
5. 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.

Where it's running

• Deparment of Hematology, Peking University People's Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yu Wang
• Email: ywyw3172@sina.com
• Phone: 86-13552647384

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.