Acute Myeloid Leukaemia (AML), Measurable Residual Disease (MRD)
Conditions
Brief summary
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
DRUGSorafenib (SORA)
Sorafenib (SORA) was administered at 400mg twice daily on days 1 to 28.
DRUGVenetoclax (VEN)
Venetoclax (VEN) was administered at 400mg/day on days 1 to 28.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Molecular response rate after three courses of treatment | 1 year | After three courses of treatment, MRD level decreased ≥1 log10 compared with the pre-treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MRD negative rates after three courses of treatment | 1 year | MRD negative rates after three courses of treatment |
| Cumulative incidence of relapse (CIR) | 3 year | Will calculate time from hematological complete rate until relapse. |
| Event-free survival (EFS) | 3 year | Will calculate time from assignment until relapse or disease progression. |
| Overall survival (OS) | 3 year | Will calculate time from assignment until death from any cause. |
| Adverse events (AEs) | 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. |
Contacts
Primary ContactQifa Liu
Backup ContactPengcheng Shi
Outcome results
None listed