Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, S… (NCT07264010) | Clinical Trial Compass
Not Yet RecruitingPhase 2/3
Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study
87 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
Molecular response rate after three courses of treatment
Timeframe: 1 year
Trial details
NCT IDNCT07264010
SponsorNanfang Hospital, Southern Medical University