Interferon-α for TP53 Myeloid Malignancy Post Allo-HSCT
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-65
SponsorPeking University People's Hospital
About this trial
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 criteria
Qualifiers
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
Absolute neutrophil count (ANC) greater than 0.5×109/L
Disqualifiers
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
Trial design
Treatments tested in this trial
- IFN-Α
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov