Sorafenib (SORA)
DrugSorafenib (SORA) was administered at 400mg twice daily on days 1 to 28.
NCT Number: NCT07264010
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.
Trial opening soon.
Get Notified18 year–65 year
All sexes
Interventional
Phase 2 / Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sorafenib (SORA) was administered at 400mg twice daily on days 1 to 28.
Venetoclax (VEN) was administered at 400mg/day on days 1 to 28.
Time frame: 1 year
After three courses of treatment, MRD level decreased ≥1 log10 compared with the pre-treatment
Time frame: 1 year
MRD negative rates after three courses of treatment
Time frame: 3 year
Will calculate time from hematological complete rate until relapse.
Time frame: 3 year
Will calculate time from assignment until relapse or disease progression.
Time frame: 3 year
Will calculate time from assignment until death from any cause.
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.
Contact information is provided by the study sponsor or research team.
Pengcheng Shi
CONTACT
Qifa Liu
CONTACT
Nanfang Hospital, Southern Medical University
Other
Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for Measurable Residual Disease Persisting Acute Myeloid Leukemia: a Prospective, Single-arm, Multicenter Clinical Study
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