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

NCT07264010 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: NFEC-2025-434
• Study Type: interventional
• Target: 87
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• MRD negative rates after three courses of treatment

  1 year

• Cumulative incidence of relapse (CIR)

  3 year

• Event-free survival (EFS)

  3 year

• Overall survival (OS)

  3 year

• Adverse events (AEs)

  3 year

Study Arms (1)

SORA+VEN

EXPERIMENTAL

sorafenib combined with venetoclax

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

Interventions

Sorafenib (SORA) DRUG

Sorafenib (SORA) was administered at 400mg twice daily on days 1 to 28.

SORA+VEN

Venetoclax (VEN) DRUG

Venetoclax (VEN) was administered at 400mg/day on days 1 to 28.

SORA+VEN

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Neoplasm, Residual

Interventions

Sorafenib; venetoclax

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Qifa Liu

CONTACT

+86-020-62787883; liuqifa628@163.com

Pengcheng Shi

CONTACT

+86-020-61641615; shpch283@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2028
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share