Acute Myeloid Leukaemia (AML)Phase 2/3NCT07264010
Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study
A Phase 2/3 study testing Sorafenib (SORA) and Venetoclax (VEN) in people with Acute Myeloid Leukaemia (AML) and Measurable Residual Disease (MRD), run by Nanfang Hospital, Southern Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukaemia (AML), Measurable Residual Disease (MRD)
- What is being tested?
- Sorafenib (SORA) and Venetoclax (VEN)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Dec 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Being tested
- Sorafenib (SORA), Venetoclax (VEN)
- Medical subject headings
- Leukemia, Myeloid, Acute, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| SORA+VEN | Experimental | sorafenib combined with venetoclax Receives: Drug: Sorafenib (SORA); Drug: Venetoclax (VEN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Molecular response rate after three courses of treatment
After three courses of treatment, MRD level decreased ≥1 log10 compared with the pre-treatment
Measured: 1 year
Secondary outcomes (5)
MRD negative rates after three courses of treatment
MRD negative rates after three courses of treatment
Measured: 1 year
Cumulative incidence of relapse (CIR)
Will calculate time from hematological complete rate until relapse.
Measured: 3 year
Event-free survival (EFS)
Will calculate time from assignment until relapse or disease progression.
Measured: 3 year
Overall survival (OS)
Will calculate time from assignment until death from any cause.
Measured: 3 year
Adverse events (AEs)
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.
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukaemia (AML)Studies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264010
- Sponsor's protocol ID
- NFEC-2025-434
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07264010
- Acronym / sponsor ID
- NFEC-2025-434
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SORA+VEN | Experimental | Drug: Sorafenib (SORA), Drug: Venetoclax (VEN)sorafenib combined with venetoclax |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib (SORA)Sorafenib (SORA) was administered at 400mg twice daily on days 1 to 28. | Drug | SORA+VEN |
| Venetoclax (VEN)Venetoclax (VEN) was administered at 400mg/day on days 1 to 28. | Drug | SORA+VEN |
Primary outcome
Molecular response rate after three courses of treatment
Time frame: 1 year
After three courses of treatment, MRD level decreased ≥1 log10 compared with the pre-treatment
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sorafenib (SORA) and Venetoclax (VEN) in people with Acute Myeloid Leukaemia (AML) and Measurable Residual Disease (MRD), run by Nanfang Hospital, Southern Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qifa Liu (+86-020-62787883, liuqifa628@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular response rate after three courses of treatment (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.