Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
Peking University People's Hospital
96 participants
Jan 1, 2023
INTERVENTIONAL
Conditions
Summary
This research focuses on a prospective, randomized, controlled trial of "Interferon-alpha as maintenance therapy for favorable-risk acute myeloid leukemia." By fully utilizing prospective, randomized, controlled clinical trial and studying the negative conversion of MRD and the survival of favorable-risk AML patients, it aims to explore the efficacy and safety of Interferon-alpha in the maintenance treatment of favorable-risk AML and identify effective measures to prevent relapse, thereby improving the survival of favorable-risk AML patients. The primary endpoint is the negative conversion of MRD at 6 months. The secondary endpoints include the 2-year cumulative incidence of relapse, 2-year event-free survival (EFS), 2-year overall survival (OS), and safety.
Eligibility
Inclusion Criteria7
- 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 Criteria10
- 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.
Interventions
Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.
Locations(1)
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NCT06802718