NCT07925554 Interferon-α Maintenance in Favorable-Risk AML
| NCT ID | NCT07925554 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peking University People's Hospital |
| Condition | AML (Acute Myeloid Leukemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-03-28 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2026-03-28 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-70 years, inclusive. 2. Newly diagnosed favorable-risk acute myeloid leukemia (AML) according to the 2022 European LeukemiaNet (ELN) risk classification. 3. Achieved first complete remission (CR1) after 1-2 courses of standard chemotherapy. 4. Completed 4-6 courses of consolidation chemotherapy, including at least 2 courses of high-dose cytarabine (HiDAC). 5. 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. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. 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. 8. Renal function: serum creatinine ≤1.5 times ULN, based on laboratory tests performed within 2 weeks before enrollment. \- Exclusion Criteria: 1. Acute promyelocytic leukemia (APL). 2. Patients who strongly prefer transplantation, or who have an indication for transplantation but are unable to undergo transplantation. 3. Uncontrolled active infection. 4. Severe organ failure. 5. Pregnancy. 6. Unwillingness to receive interferon therapy. 7. History of hyperthyroidism or hypothyroidism. 8. Participation in another clinical study within 1 month before enrollment. -
Contact & Investigator
Xiangyu Zhao
STUDY CHAIR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT07925554 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying AML (Acute Myeloid Leukemia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07925554 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07925554 currently recruiting?
Yes, NCT07925554 is actively recruiting participants. Contact the research team at rmkyc@163.com for enrollment information.
Where is the NCT07925554 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07925554 clinical trial?
NCT07925554 is sponsored by Peking University People's Hospital. The principal investigator is Xiangyu Zhao at Peking University People's Hospital. The trial plans to enroll 30 participants.
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