Clinical trial NCT06802718: Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
Official title: A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Myeloid Leukemia
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: 6-month negative conversion of MRD
timeFrame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
Secondary outcomes:
measure: CIR
timeFrame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
measure: EFS
timeFrame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
measure: OS
timeFrame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
measure: Treatment-related Safety Indicators
timeFrame: Participants will be followed for a minimum of 2 years until the last enrolled participants was followed up for at least 2 years.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: