Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT

Launched by PEKING UNIVERSITY PEOPLE'S HOSPITAL · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called interferon-α for patients with specific types of blood cancers known as acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), particularly those who have a mutation in a gene called TP53. The researchers want to see if giving interferon-α can help prevent these patients from relapsing after they have received a special type of stem cell transplant. Only patients who are free of detectable cancer signs shortly after the transplant are eligible for this study.

To qualify for the trial, participants must be between the ages of 12 and 65, have a confirmed diagnosis of AML or MDS, and meet certain health criteria, such as having stable blood counts and good organ function. Participants will receive the study treatment and will be monitored closely to see how effective it is in reducing the chances of their cancer returning. If you or someone you know is considering joining this trial, it’s important to discuss any questions or concerns with your healthcare provider to understand more about the process and what to expect.

Gender

ALL

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.