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NCT Number: NCT07264010

Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sorafenib (SORA)

Drug

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

Venetoclax (VEN)

Drug

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

Primary outcomes

  1. Molecular response rate after three courses of treatment

    Time frame: 1 year

    After three courses of treatment, MRD level decreased ≥1 log10 compared with the pre-treatment

Secondary outcomes

  1. MRD negative rates after three courses of treatment

    Time frame: 1 year

    MRD negative rates after three courses of treatment

  2. Cumulative incidence of relapse (CIR)

    Time frame: 3 year

    Will calculate time from hematological complete rate until relapse.

  3. Event-free survival (EFS)

    Time frame: 3 year

    Will calculate time from assignment until relapse or disease progression.

  4. Overall survival (OS)

    Time frame: 3 year

    Will calculate time from assignment until death from any cause.

  5. Adverse events (AEs)

    Time frame: 3 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Dec 4, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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