Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study
NCT ID: NCT07264010
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2/PHASE3
87 participants
INTERVENTIONAL
2025-12-01
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SORA+VEN
sorafenib combined with venetoclax
Sorafenib (SORA)
Sorafenib (SORA) was administered at 400mg twice daily on days 1 to 28.
Venetoclax (VEN)
Venetoclax (VEN) was administered at 400mg/day on days 1 to 28.
Interventions
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Sorafenib (SORA)
Sorafenib (SORA) was administered at 400mg twice daily on days 1 to 28.
Venetoclax (VEN)
Venetoclax (VEN) was administered at 400mg/day on days 1 to 28.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Central Contacts
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Other Identifiers
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NFEC-2025-434
Identifier Type: -
Identifier Source: org_study_id
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