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

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

This study is testing if a treatment called interferon-α can help prevent relapse in patients with acute myeloid leukemia or myelodysplastic syndrome who have a specific gene mutation and are in remission after a stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 12 Years to 65 Years
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06130579 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 12-65 with MDS or AML and a TP53 mutation who are in remission and have no minimal residual disease post-transplant.

Not a fit: Patients with severe organ dysfunction, uncontrolled graft-versus-host disease, or other malignancies requiring treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly lower the risk of relapse in patients with TP53-mutated myeloid malignancies after transplantation.

How similar studies have performed: While the use of interferon-α in this context is novel, previous studies have shown promise in using similar approaches for other malignancies.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Study coordinator: Yu Wang

Conditions Myeloid Leukemia; Myelodysplastic Syndromes; IFN-α; Preventing relapse; allo-HSCT