Tests interferon-alpha as maintenance treatment in favorable-risk acute myeloid leukemia
Tests interferon-alpha after initial treatment in adults with acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18 to 70 with newly diagnosed favorable-risk acute myeloid leukemia who are in first remission after chemotherapy. It tests interferon-alpha as maintenance treatment.
- Age
- 18 to 70 years, both included
- Sex
- All sexes can join
- Disease stage
- Newly diagnosed favorable-risk AML (2022 ELN risk group). In first complete remission (CR1) after consolidation chemotherapy. ECOG performance status 0-2.
- Earlier treatment
- Must have had 1-2 cycles of standard chemotherapy to reach remission. Must have finished 4-6 cycles of consolidation chemotherapy, with at least 2 cycles of high-dose Cytarabine (HDAC).
- Biomarker or test result
- Flow cytometry MRD negative at the end of consolidation. Molecular MRD genes (RUNX1::RUNX1T1, NPM1, CBFb::MYH11) down by more than 3 log but still detectable. Liver and kidney tests within set limits (ALT and AST ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times, creatinine ≤ 1.5 times).
Main reasons for not taking part
- Acute promyelocytic leukemia (APL)
- AML with normal karyotype and bZIP mutations in CEBPA
- Second remission or later (CR2 or beyond)
- Uncontrolled active infection or severe organ dysfunction
- Pregnancy, or past hyperthyroidism or hypothyroidism
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06802718, who can take part
Where in China
- Peking University People's HospitalBeijing, ChinaContact: Feifei TangTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking University People's Hospital
- Trial code
- NCT06802718
- Record updated
- 31 January 2025
- Original description
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.Read full original descriptionShow less
A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia
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.
Inclusion: 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: Patients strongly demanding transplantation, and with indications for transplantation but not eligible for transplantation; Previous hyperthyroidism or hypothyroidism; Uncontrolled active infection; Acute promyelocytic leukemia (APL); AML with normal karyotype and bZIP intramolecular mutations in CEBPA; ≥ CR2 status; Severe organ dysfunction; Pregnancy; Unwillingness to undergo interferon treatment; Participation in other clinical trials within one month.