Acute Myeloid Leukemia
Conditions
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.
Interventions
DRUGInterferon
Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6-month negative conversion of MRD | 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
| Measure | Time frame | Description |
|---|---|---|
| CIR | 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. |
| EFS | 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. |
| OS | 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. |
| Treatment-related Safety Indicators | 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. |
Countries
China
Contacts
Primary ContactFeifei Tang, Prof
Outcome results
None listed