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

Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for Measurable Residual Disease Persisting Acute Myeloid Leukemia: a Prospective, Single-arm, Multicenter Clinical Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Myeloid Leukaemia (AML); Measurable Residual Disease (MRD)
• Intervention / Treatment: Drug: Sorafenib (SORA); Drug: Venetoclax (VEN)

• Study Type: Interventional
• Enrollment (Estimated): 87
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Qifa Liu; Phone Number: +86-020-62787883; Email: liuqifa628@163.com
• Study Contact Backup: Name: Pengcheng Shi; Phone Number: +86-020-61641615; Email: shpch283@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SORA+VEN; sorafenib combined with venetoclax	Drug: Sorafenib (SORA); Sorafenib (SORA) was administered at 400mg twice daily on days 1 to 28.; Drug: Venetoclax (VEN); Venetoclax (VEN) was administered at 400mg/day on days 1 to 28.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Molecular response rate after three courses of treatment	After three courses of treatment, MRD level decreased ≥1 log10 compared with the pre-treatment	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRD negative rates after three courses of treatment	MRD negative rates after three courses of treatment	1 year
Cumulative incidence of relapse (CIR)	Will calculate time from hematological complete rate until relapse.	3 year
Event-free survival (EFS)	Will calculate time from assignment until relapse or disease progression.	3 year
Overall survival (OS)	Will calculate time from assignment until death from any cause.	3 year
Adverse events (AEs)	Treatment-related AEs were defined as those that occurred from the first dose until 30 days after the discontinuation of treatment. The severity of AEs was graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0, except for haematoloical adverse events. Grade 4 hematological adverse events were defined as either an absolute neutrophil count less than 0.5×10⁹cells per L or a platelet count less than 20×10⁹per L.	3 year

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028

Study Registration Dates

• First Submitted: November 23, 2025
• First Submitted That Met QC Criteria: November 23, 2025
• First Posted (Estimated): December 4, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 23, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Neoplastic Processes; Leukemia, Myeloid; Leukemia; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Neoplasm, Residual; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amides; Benzene Derivatives; Urea; Acids, Heterocyclic; Phenylurea Compounds; Niacinamide; Nicotinic Acids; Sorafenib; venetoclax
• Other Study ID Numbers: NFEC-2025-434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No