Interferon-α Maintenance in Favorable-Risk AML

Interferon-α as Maintenance Therapy for Favorable-Risk Acute Myeloid Leukemia: A Prospective, Single-Arm Study

Acute myeloid leukemia (AML) is a blood cancer with a substantial risk of relapse after initial treatment. Although patients with favorable-risk AML generally have better outcomes, relapse remains a major concern. Interferon-alpha (IFN-α) may help prevent relapse, but its effectiveness as maintenance therapy has not been confirmed in prospective studies.

This prospective, single-arm study aims to evaluate the efficacy and safety of IFN-α as maintenance therapy in patients with favorable-risk AML. Participants will receive IFN-α maintenance treatment and will be followed for disease relapse, survival, and treatment-related adverse events.

Study Overview

• Status: Recruiting
• Conditions: AML (Acute Myeloid Leukemia)
• Intervention / Treatment: Biological: pegylated interferon alfa-2b

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yuanjie Ding; Phone Number: 010-88325948; Email: rmkyc@163.com
• Study Contact Backup: Name: Fei-fei Tang; Phone Number: 86-13521893860; Email: bjmugirl@163.com

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
    • Contact: Fei-fei Tang; Phone Number: 86-13581671687; Email: bjmugirl@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-70 years, inclusive.

2. Newly diagnosed favorable-risk acute myeloid leukemia (AML) according to the 2022 European LeukemiaNet (ELN) risk classification.

3. Achieved first complete remission (CR1) after 1-2 courses of standard chemotherapy.

4. Completed 4-6 courses of consolidation chemotherapy, including at least 2 courses of high-dose cytarabine (HiDAC).

5. Bone marrow examination at the end of consolidation therapy confirms continued CR1, with flow cytometric measurable residual disease (MRD) <0.1% and/or a >3-log reduction in molecular disease burden.

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

7. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), and total bilirubin ≤2 times ULN, based on laboratory tests performed within 2 weeks before enrollment.

8. Renal function: serum creatinine ≤1.5 times ULN, based on laboratory tests performed within 2 weeks before enrollment.

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Exclusion Criteria:

1. Acute promyelocytic leukemia (APL).
2. Patients who strongly prefer transplantation, or who have an indication for transplantation but are unable to undergo transplantation.
3. Uncontrolled active infection.
4. Severe organ failure.
5. Pregnancy.
6. Unwillingness to receive interferon therapy.
7. History of hyperthyroidism or hypothyroidism.
8. Participation in another clinical study within 1 month before enrollment. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Peginterferon Alfa-2b Maintenance Therapy; Eligible patients with favorable-risk acute myeloid leukemia (AML) in first complete remission (CR1) after consolidation chemotherapy will receive peginterferon alfa-2b injection at a dose of 135 μg once weekly by subcutaneous injection for 6 months. Participants will be monitored for disease relapse, measurable residual disease (MRD), survival, and treatment-related adverse events, with follow-up for 2 years after enrollment.

Biological: pegylated interferon alfa-2b; Pegylated interferon alfa-2b injection, administered at a dose of 135 μg once weekly by subcutaneous injection for 6 months as maintenance therapy in patients with favorable-risk acute myeloid leukemia (AML) in first complete remission (CR1) after consolidation chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-Year Cumulative Incidence of Relapse	The proportion of patients who experience disease relapse within 2 years after enrollment. Relapse is defined as bone marrow blasts ≥5%, detection of leukemic cells in peripheral blood, or extramedullary leukemia.	2 years after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2-Year Event-Free Survival (EFS)	Event-free survival is defined as the time from enrollment to the first occurrence of molecular progression, hematologic relapse, or death from any cause.	2 years after enrollment
2-Year Overall Survival (OS)	Overall survival is defined as the time from enrollment to death from any cause. Participants who are alive at the last follow-up will be censored.	2 years after enrollment
MRD Conversion Rate Among Patients With MRD-Positive Disease at Enrollment	The proportion of patients with measurable residual disease (MRD)-positive status at enrollment who achieve MRD-negative status during follow-up, assessed by multiparameter flow cytometry and/or quantitative PCR.	Up to 2 years after enrollment
Number of Participants With Grade 3 or Higher Adverse Events	The number of participants experiencing grade 3 or higher adverse events during peginterferon alfa-2b maintenance therapy, including hematologic and hepatic toxicities. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.	During the 6-month maintenance treatment period

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Chair: Xiangyu Zhao, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2026
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: November 3, 2026
• First Submitted That Met QC Criteria: November 3, 2026
• First Posted (Actual): November 9, 2026

Study Record Updates

• Last Update Posted (Actual): November 9, 2026
• Last Update Submitted That Met QC Criteria: November 3, 2026
• Last Verified: November 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; peginterferon alfa-2b
• Other Study ID Numbers: IFN-α in AML Maintenance

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No