AML (Acute Myeloid Leukemia)Phase 2NCT07925554
Interferon-α Maintenance in Favorable-Risk AML
A Phase 2 study testing pegylated interferon alfa-2b in people with AML (Acute Myeloid Leukemia), run by Peking University People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- AML (Acute Myeloid Leukemia)
- What is being tested?
- pegylated interferon alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Mar 2026to 31 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- -
Who cannot join
- Acute promyelocytic leukemia (APL).
- Patients who strongly prefer transplantation, or who have an indication for transplantation but are unable to undergo transplantation.
- Uncontrolled active infection.
- Severe organ failure.
- Pregnancy.
- Unwillingness to receive interferon therapy.
- History of hyperthyroidism or hypothyroidism.
- Participation in another clinical study within 1 month before enrollment. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing
Fei-fei Tang, 86-13581671687, bjmugirl@163.com
About this study
Official title: Interferon-α as Maintenance Therapy for Favorable-Risk Acute Myeloid Leukemia: A Prospective, Single-Arm Study
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.
- Conditions
- AML (Acute Myeloid Leukemia)
- Being tested
- pegylated interferon alfa-2b
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated interferon alfa-2bBiological
Pegylated interferon alfa-2b injection, administered at a dose of 135 μg once weekly by subcutaneous injection for 6 months as maintenance therapy in patients with favorable-risk acute myeloid leukemia (AML) in first complete remission (CR1) after consolidation chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon Alfa-2b Maintenance Therapy | Experimental | Eligible patients with favorable-risk acute myeloid leukemia (AML) in first complete remission (CR1) after consolidation chemotherapy will receive peginterferon alfa-2b injection at a dose of 135 μg once weekly by subcutaneous injection for 6 months. Participants will be monitored for disease relapse, measurable residual disease (MRD), survival, and treatment-related adverse events, with follow-up for 2 years after enrollment. Receives: Biological: pegylated interferon alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-Year Cumulative Incidence of Relapse
The proportion of patients who experience disease relapse within 2 years after enrollment. Relapse is defined as bone marrow blasts ≥5%, detection of leukemic cells in peripheral blood, or extramedullary leukemia.
Measured: 2 years after enrollment
Secondary outcomes (4)
2-Year Event-Free Survival (EFS)
Event-free survival is defined as the time from enrollment to the first occurrence of molecular progression, hematologic relapse, or death from any cause.
Measured: 2 years after enrollment
2-Year Overall Survival (OS)
Overall survival is defined as the time from enrollment to death from any cause. Participants who are alive at the last follow-up will be censored.
Measured: 2 years after enrollment
MRD Conversion Rate Among Patients With MRD-Positive Disease at Enrollment
The proportion of patients with measurable residual disease (MRD)-positive status at enrollment who achieve MRD-negative status during follow-up, assessed by multiparameter flow cytometry and/or quantitative PCR.
Measured: Up to 2 years after enrollment
Number of Participants With Grade 3 or Higher Adverse Events
The number of participants experiencing grade 3 or higher adverse events during peginterferon alfa-2b maintenance therapy, including hematologic and hepatic toxicities. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: During the 6-month maintenance treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start28 Mar 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML (Acute Myeloid Leukemia)Studies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiao-Jun Huang, Peking University People's Hospital
- Investigators
- Xiangyu Zhao, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925554
- Sponsor's protocol ID
- IFN-α in AML Maintenance
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon-α as Maintenance Therapy for Favorable-Risk Acute Myeloid Leukemia: A Prospective, Single-Arm Study
- ClinicalTrials.gov ID
- NCT07925554
- Acronym / sponsor ID
- IFN-α in AML Maintenance
- Conditions
- AML (Acute Myeloid Leukemia)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 28 Mar 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon Alfa-2b Maintenance Therapy | Experimental | Biological: pegylated interferon alfa-2bEligible patients with favorable-risk acute myeloid leukemia (AML) in first complete remission (CR1) after consolidation chemotherapy will receive peginterferon alfa-2b injection at a dose of 135 μg once weekly by subcutaneous injection for 6 months. Participants will be monitored for disease relapse, measurable residual disease (MRD), survival, and treatment-related adverse events, with follow-up for 2 years after enrollment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (8 listed)
- Acute promyelocytic leukemia (APL).
- Patients who strongly prefer transplantation, or who have an indication for transplantation but are unable to undergo transplantation.
- Uncontrolled active infection.
- Severe organ failure.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pegylated interferon alfa-2bPegylated interferon alfa-2b injection, administered at a dose of 135 μg once weekly by subcutaneous injection for 6 months as maintenance therapy in patients with favorable-risk acute myeloid leukemia (AML) in first complete remission (CR1) after consolidation chemotherapy. | Biological | Peginterferon Alfa-2b Maintenance Therapy |
Primary outcome
2-Year Cumulative Incidence of Relapse
Time frame: 2 years after enrollment
The proportion of patients who experience disease relapse within 2 years after enrollment. Relapse is defined as bone marrow blasts ≥5%, detection of leukemic cells in peripheral blood, or extramedullary leukemia.
4 secondary outcomes
2-Year Event-Free Survival (EFS)
Time frame: 2 years after enrollment
2-Year Overall Survival (OS)
Time frame: 2 years after enrollment
MRD Conversion Rate Among Patients With MRD-Positive Disease at Enrollment
Time frame: Up to 2 years after enrollment
Number of Participants With Grade 3 or Higher Adverse Events
Time frame: During the 6-month maintenance treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiangyu Zhao study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pegylated interferon alfa-2b in people with AML (Acute Myeloid Leukemia), run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuanjie Ding (010-88325948, rmkyc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-Year Cumulative Incidence of Relapse (time frame: 2 years after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.