Actively Recruiting
Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
Led by Peking University People's Hospital · Updated on 2025-01-31
96
Participants Needed
1
Research Sites
204 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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.
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
F
Feifei Tang, Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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