Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study
- Sponsor
- Nanfang Hospital, Southern Medical University
- Study ID
- NCT07264010
- Phase
- PHASE2/PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Acute Myeloid Leukaemia (AML)
- Measurable Residual Disease (MRD)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sorafenib (SORA) — DRUGSorafenib (SORA) was administered at 400mg twice daily on days 1 to 28.
- Venetoclax (VEN) — DRUGVenetoclax (VEN) was administered at 400mg/day on days 1 to 28.
Study Details
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.
Key Dates
- Start date
- Dec 1, 2025
- Status verified
- Nov 2025
- Primary completion
- Dec 30, 2026
- Completion
- Dec 30, 2028
Study Design
- Enrollment
- 87 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: SORA+VENsorafenib combined with venetoclax
Primary Outcome Measure
Molecular response rate after three courses of treatment [ Time Frame: 1 year ]
Central Contacts
- Qifa Liu+86-020-62787883
- Pengcheng Shi+86-020-61641615
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