Clinical trial · Interventional
Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study
Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for Measurable Residual Disease Persisting Acute Myeloid Leukemia: a Prospective, Single-arm, Multicenter Clinical Study
NCT07264010CI-TRIAL-00098428not yet recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukaemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Measurable Residual Disease (MRD) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sorafenib (SORA) | Drug | Sorafenib | ALIAS |
| Venetoclax (VEN) | Drug | Venetoclax | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SORA+VEN
- description
- sorafenib combined with venetoclax
- interventionNames
- Drug: Sorafenib (SORA)
- Drug: Venetoclax (VEN)
Primary outcomes (1)
- measure
- Molecular response rate after three courses of treatment
- timeFrame
- 1 year
- description
- After three courses of treatment, MRD level decreased ≥1 log10 compared with the pre-treatment
Secondary outcomes (5)
- measure
- MRD negative rates after three courses of treatment
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.