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

January 25, 2025 updated by: Xiao-Jun Huang, Peking University People's Hospital

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

96

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
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
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.
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
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.
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
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.
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
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.
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

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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