Interferon-α Maintenance for Favorable-Risk AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, single-arm trial enrolling adults with newly diagnosed favorable-risk AML who have achieved first complete remission after consolidation chemotherapy. Participants will receive pegylated interferon alfa-2b as maintenance therapy and be followed for relapse, survival, and treatment-related adverse events. The study focuses on patients with very low measurable residual disease and good performance status, aiming to determine the safety and potential relapse-prevention benefits of IFN-α maintenance. Outcomes will inform whether this maintenance approach deserves further evaluation in prospective comparisons.

Why it matters

Who can join: the full rules

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.

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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. -

Where it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yuanjie Ding
• Email: rmkyc@163.com
• Phone: 010-88325948

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.