Clinical trial · Interventional
Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interferon Group
- description
- Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.
- interventionNames
- Drug: Interferon
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Observational follow-up without receiving any maintenance treatment.
Primary outcomes (1)
- 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.
- description
- MFC-MRD or RT-PCR genes (AML1-ETO, NPM1, and CBFb-MYH11) transition from positive to negative.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available