RecruitingPhase 3NCT06802718

Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia

A Prospective Randomized Controlled Trial of Interferon-alpha As Maintenance Therapy for Favorable-risk Acute Myeloid Leukemia


Sponsor

Peking University People's Hospital

Enrollment

96 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether interferon-alpha — a medication that boosts immune activity — given after consolidation chemotherapy can help prevent relapse in patients with favorable-risk acute myeloid leukemia (AML) who are in remission but still have tiny amounts of cancer detectable in the blood. **You may be eligible if...** - You are between 18 and 70 years old - You have favorable-risk AML (per 2022 ELN classification) - You achieved complete remission after 1–2 cycles of standard chemotherapy - You completed 4–6 cycles of consolidation chemotherapy - After treatment, a sensitive blood test (MRD) still detects small amounts of leukemia - Your general health is adequate (ECOG 0–2) **You may NOT be eligible if...** - Your AML is in active relapse - You have significant organ dysfunction - You have an active infection or autoimmune disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInterferon

Polyethylene glycol interferon alpha-2b injection 135 μg/week was subcutaneously given for 6 months.


Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06802718


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