Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia

Phase 3

Recruiting

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Interferon

• Registration Number: NCT06802718
• Lead Sponsor: Peking University People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2024-12-21
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-25
• Last Update Submitted: 2025-01-25
• Study First Posted: 2025-01-31
• Last Update Posted: 2025-01-31
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 96

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interferon Group	Interferon	Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.

Primary Outcome Measures

Name	Time	Method
6-month negative conversion of MRD	Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.	MFC-MRD or RT-PCR genes (AML1-ETO, NPM1, and CBFb-MYH11) transition from positive to negative.

Secondary Outcome Measures

Name	Time	Method
CIR	Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.	The number of patients with relapse calculated from the randomization time to the last follow-up time.
EFS	Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.	Events include treatment failure (MRD positivity or molecular progression), relapse, or death from any cause.
OS	Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.	calculated from randomization time to the time of death or the last follow-up time.
Treatment-related Safety Indicators	Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.	Mainly include hematologic toxicity and liver toxicity.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China