NCT07925554RecruitingPhase 2
Interferon-α Maintenance in Favorable-Risk AML
Interferon-α as Maintenance Therapy for Favorable-Risk Acute Myeloid Leukemia: A Prospective, Single-Arm Study
Source: ClinicalTrials.gov · Last updated 9 Nov 2026
Brief summary (registry, in English)
Acute myeloid leukemia (AML) is a blood cancer with a substantial risk of relapse after initial treatment. Although patients with favorable-risk AML generally have better outcomes, relapse remains a major concern. Interferon-alpha (IFN-α) may help prevent relapse, but its effectiveness as maintenance therapy has not been confirmed in prospective studies. This prospective, single-arm study aims to evaluate the efficacy and safety of IFN-α as maintenance therapy in patients with favorable-risk AML. Participants will receive IFN-α maintenance treatment and will be followed for disease relapse, survival, and treatment-related adverse events.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 3 Nov 2026
- Start date
- 28 Mar 2026
- Primary completion date
- 31 Oct 2027
- Lead sponsor
- Peking University People's Hospital
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT07925554
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 30
- From 28 Mar 2026 to the primary completion date, 31 Oct 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
AI-kivonat: who the study is looking for
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 with a type of acute myeloid leukemia (AML) that has a lower risk of coming back. They are in remission after chemotherapy. They will get weekly interferon injections for 6 months.
- Age
- 18 to 70 years
- Sex
- All sexes can join.
- Disease stage
- Newly diagnosed AML in the favorable-risk group (2022 European LeukemiaNet classification). First complete remission after 1-2 courses of chemotherapy, still in remission at the end of consolidation.
- Earlier treatment
- Must have finished 4-6 courses of consolidation chemotherapy, including at least 2 courses of high-dose cytarabine (HiDAC).
- Biomarker or test result
- Bone marrow test at the end of consolidation shows measurable residual disease (MRD) below 0.1% and/or a drop of more than 3-log in molecular disease burden. ECOG performance status 0-2. Liver and kidney blood tests within set limits.
Main reasons for not taking part
- Acute promyelocytic leukemia (APL)
- Strong wish for a transplant, or a transplant is needed but cannot be done
- Uncontrolled active infection or severe organ failure
- Pregnancy
- History of an overactive or underactive thyroid
Read by machine on 10 Nov 2026.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who strongly prefer transplantation, or who have an indication for transplantation but are unable to undergo transplantation.
- Unwillingness to receive interferon therapy.
- Participation in another clinical study within 1 month before enrollment. -
Other illness
- Uncontrolled active infection.
- Severe organ failure.
- History of hyperthyroidism or hypothyroidism.
Other
- Acute promyelocytic leukemia (APL).
- Pregnancy.
Who the study is looking for
- Age 18-70 years, inclusive.
- Newly diagnosed favorable-risk acute myeloid leukemia (AML) according to the 2022 European LeukemiaNet (ELN) risk classification.
- Achieved first complete remission (CR1) after 1-2 courses of standard chemotherapy.
- Completed 4-6 courses of consolidation chemotherapy, including at least 2 courses of high-dose cytarabine (HiDAC).
- Bone marrow examination at the end of consolidation therapy confirms continued CR1, with flow cytometric measurable residual disease (MRD) <0.1% and/or a >3-log reduction in molecular disease burden.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal (ULN), and total bilirubin ≤2 times ULN, based on laboratory tests performed within 2 weeks before enrollment.
- Renal function: serum creatinine ≤1.5 times ULN, based on laboratory tests performed within 2 weeks before enrollment.
- -
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.