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

Peking University

Status and phase

Enrolling

Phase 3

Conditions

Acute Myeloid Leukemia

Treatments

Drug: Interferon

Study type

Interventional

Funder types

Other

Identifiers

NCT06802718

2023PHD001-001

Details and patient eligibility

About

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.

Enrollment

96 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.