Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
Interferon-α for Preventing Relapse in TP53+ Myeloid Malignancy Post Allo-HSCT
Peking University People's Hospital
35 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria8
- 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 Criteria8
- 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.
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Interventions
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.
Locations(1)
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NCT06130579