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NCT Number: NCT06802718

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.

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Key information

Conditions

Acute Myeloid Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Feifei Tang

CONTACT

[email protected]

13581671687

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interferon

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Feifei Tang, Prof

CONTACT

[email protected]

13581671687

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 31, 2025
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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