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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia
• Intervention / Treatment: Drug: Interferon

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Feifei Tang, Prof; Phone Number: 13581671687; Email: bjmugirl@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Feifei Tang; Phone Number: 13581671687; Email: bjmugirl@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interferon Group; Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.	Drug: Interferon; Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.
No Intervention: Control Group; Observational follow-up without receiving any maintenance treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6-month negative conversion of MRD	MFC-MRD or RT-PCR genes (AML1-ETO, NPM1, and CBFb-MYH11) transition from positive to negative.	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

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 21, 2024
• First Submitted That Met QC Criteria: January 25, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 25, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Anti-Infective Agents; Antineoplastic Agents; Antiviral Agents; Interferons
• Other Study ID Numbers: 2023PHD001-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No