Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study

Nanfang Hospital, Southern Medical University

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Measurable Residual Disease (MRD); Acute Myeloid Leukaemia (AML)

Treatments: Drug: Sorafenib (SORA); Drug: Venetoclax (VEN)

Study type: Interventional

Funder types: Other

Identifiers

NCT07264010

NFEC-2025-434

Details and patient eligibility

About

The purpose of this study is to explore the efficacy and safety of sorafenib combined with venetoclax as pre-emptive therapy strategy for measurable residual disease persisting acute myeloid leukemia.

Enrollment: 87 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Voluntary signing of informed consent form;
• Liver and kidney function: Blood bilirubin ≤ 35 μ mol/L, AST/ALT < 2 times the upper limit of normal, blood creatinine ≤ 150 μ mol/L;
• Normal heart function (EF ≥ 50%, NYHA I/II);
• Physical condition score 0-2 (ECOG score);
• Non pregnant and lactating women. For all women of childbearing age, a pregnancy test must be conducted to determine hCG levels in order to exclude pregnancy status;
• For all men of childbearing age, contraceptive measures must be taken during sorafenib treatment until 3 months after discontinuation.

Exclusion criteria

• Acute promyelocytic leukemia;
• Hematological non-remisssion or recurrence;
• Uncontrolled infection or grade 3-4 graft-versus-host disease (GVHD);
• Allergies or contraindications to any of the drugs involved in the protocol;
• Severe organ dysfunction such as heart, liver, kidneys, lungs, etc.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

SORA+VEN

Experimental group

Description:

sorafenib combined with venetoclax

Treatment:

Drug: Venetoclax (VEN)

Drug: Sorafenib (SORA)