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Sorafenib combined with venetoclax as pre-emptive therapy strategy for measurable residual disease persisting acute myeloid leukemia: 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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112555
Enrollment
Unknown
Registered
2025-11-17
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MRD positive acute myeloid leukemia

Interventions

Experiment group:Sorafenib combined with venetoclax

Sponsors

Nanfang Hospital, Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Signed informed consent voluntarily; 2.Age>= 18; 3.Liver and kidney functions: blood bilirubin = 50%, New York Heart Function Classification NYHA I/II); 5.ECOG score: Physical condition score 0-2; 6.Non pregnant and lactating women; 7.For all women of childbearing age, hCG must be measured by pregnancy test to exclude pregnancy status; 8.For all men of childbearing age, contraceptive measures must be taken during sorafenib treatment until 3 months after withdrawal.

Exclusion criteria

Exclusion criteria: 1.Acute promyelocytic leukemia; 2.Non-response or relpase; 3.Uncontrolled infection or grade 3-4 graft-versus-host diseas; 4.Allergy or contraindication to any drug involved in the protocol (including sorafenib); 5.Severe heart, liver, kidney, lung and other organ dysfunction; 6.PLT lower than 20g/l, neu lower than 0.5g/l.

Design outcomes

Primary

MeasureTime frame
Complete molecular remission rate after 3 treatment courses;Death related to adverse events;

Secondary

MeasureTime frame
Adverse events;Event free of survival;Cumulative incidence of relapse;MRD negativity;Response rate of MRD;Overall survival;

Countries

China

Contacts

Public ContactLiu Hui

Nanfang Hospital, Southern Medical University

doria2008@163.com+86 20 61641888

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026