Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Interferon.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
Overview
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.
Interventions
- Drug Interferon
Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.
Primary outcome measures
- 6-month negative conversion of MRD [Time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.]
Secondary outcome measures (4)
- CIR [Time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.]
- EFS [Time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.]
- OS [Time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.]
- Treatment-related Safety Indicators [Time frame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's Hospital — Beijing
Identifiers
NCT: NCT06802718 · 2023PHD001-001