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Not yet recruiting NCT07264010

Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study

Phase II / Phase III Interventional Acute Myeloid Leukaemia (AML) Measurable Residual Disease (MRD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sorafenib (SORA), Venetoclax (VEN).
Who it may be relevant to
Registry conditions: Acute Myeloid Leukaemia (AML), Measurable Residual Disease (MRD). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for Measurable Residual Disease Persisting Acute Myeloid Leukemia: a Prospective, Single-arm, Multicenter Clinical Study

Overview

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.

Interventions

  • Drug Sorafenib (SORA)
    Sorafenib (SORA) was administered at 400mg twice daily on days 1 to 28.
  • Drug Venetoclax (VEN)
    Venetoclax (VEN) was administered at 400mg/day on days 1 to 28.

Primary outcome measures

  • Molecular response rate after three courses of treatment [Time frame: 1 year]
Secondary outcome measures (5)
  • MRD negative rates after three courses of treatment [Time frame: 1 year]
  • Cumulative incidence of relapse (CIR) [Time frame: 3 year]
  • Event-free survival (EFS) [Time frame: 3 year]
  • Overall survival (OS) [Time frame: 3 year]
  • Adverse events (AEs) [Time frame: 3 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07264010 · NFEC-2025-434

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗