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

Last updated: January 25, 2025
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Leukemia

Acute Myeloid Leukemia

Platelet Disorders

Treatment

Interferon

Clinical Study ID

NCT06802718
2023PHD001-001
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 18-70 years old (including 18 and 70 years old) with newly diagnosedfavorable-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 ofhigh-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, andCBFb:: 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 ≤ 2times the upper limit of normal.

  • Kidney function: Creatinine ≤ 1.5 times the upper limit of normal.

Exclusion

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 fortransplantation 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

Total Participants: 96
Treatment Group(s): 1
Primary Treatment: Interferon
Phase: 3
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

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