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OncoMatch/Clinical Trials/NCT06802718

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

Is NCT06802718 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Interferon for acute myeloid leukemia.

Phase 3RecruitingPeking University People's HospitalNCT06802718Data as of May 2026

Treatment: InterferonThis 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Biomarker criteria

Excluded: CEBPA bZIP intramolecular mutation

AML with normal karyotype and bZIP intramolecular mutations in CEBPA

Allowed: RUNX1 fusion with RUNX1T1, decreased by > 3 log but still detectable

molecular MRD genes (RUNX1:: RUNX1T1, NPM1, and CBFb:: MYH11) decreased by > 3 log, but still detectable

Allowed: NPM1 mutation, decreased by > 3 log but still detectable

molecular MRD genes (RUNX1:: RUNX1T1, NPM1, and CBFb:: MYH11) decreased by > 3 log, but still detectable

Allowed: CBFB fusion with MYH11, decreased by > 3 log but still detectable

molecular MRD genes (RUNX1:: RUNX1T1, NPM1, and CBFb:: MYH11) decreased by > 3 log, but still detectable

Disease stage

Required: Stage CR1

Excluded: Stage CR2 OR GREATER

Achieved CR1 after 1-2 cycles of standard chemotherapy; At the end of consolidation treatment, bone marrow examination confirmed in CR1

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Must have received: standard chemotherapy — induction

Must have received: consolidation chemotherapy (high-dose cytarabine) — consolidation

Lab requirements

Kidney function

creatinine ≤ 1.5 times the upper limit of normal

Liver function

alt and ast ≤ 2.5 times the upper limit of normal, bilirubin ≤ 2 times the upper limit of normal

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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