Yükleniyor... / Loading...
This study evaluates the use of Interferon-alpha as maintenance therapy in patients with favorable-risk acute myeloid leukemia (AML). Patients aged 18 to 70 who achieved a first complete remission (CR1) after standard chemotherapy and completed consolidation treatment can take part. It is a Phase 3 study and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Aged 18-70 years old (including 18 and 70 years old) with newly diagnosed favorable-risk AML (2022 ELN risk group classification). * Achieved CR1 after 1-2 cycles of standard chemotherapy. * Completed 4-6 cycles of consolidation chemotherapy (including at least 2 cycles of high-dose Cytarabine HDAC regimem). * At the end of consolidation treatment, bone marrow examination confirmed in CR1, flow cytometry MRD negative, but molecular MRD genes (RUNX1:: RUNX1T1, NPM1, and CBFb:: MYH11) decreased by \> 3 log, but still detectable. * Performance status score of 0-2 (ECOG). * Liver function: ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal. * Kidney function: Creatinine ≤ 1.5 times the upper limit of normal. Exclusion Criteria: * Acute promyelocytic leukemia (APL). * AML with normal karyotype and bZIP intramolecular mutations in CEBPA. * ≥ CR2 status. * Patients strongly demanding transplantation, and with indications for transplantation but not eligible for transplantation. * Uncontrolled active infection. * Severe organ dysfunction. * Pregnancy. * Unwillingness to undergo interferon treatment. * Previous hyperthyroidism or hypothyroidism. * Participation in other clinical trials within one month.