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) — 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.

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+VEN
    sorafenib combined with venetoclax

Primary Outcome Measure

Molecular response rate after three courses of treatment [ Time Frame: 1 year ]

Central Contacts

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