Acute Myeloid LeukemiaPhase 2NCT07563179
Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia
A Phase 2 study testing Bugitinib in people with Acute Myeloid Leukemia and Relapse/Recurrence, run by Shenzhen University General Hospital at 1 site in China.
Trial summary
This is a prospective, single-arm, exploratory study evaluating the combination of Bugitinib, Venetoclax, and Cytarabine in adult patients with relapsed or refractory acute myeloid leukemia (AML), excluding M3 subtype. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Myeloid Leukemia, Relapse/Recurrence
- What is being tested?
- Bugitinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2026to 30 Jun 2029
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Age 18-70 years (inclusive), regardless of sex;
- Diagnosis of non-M3 acute myeloid leukemia (AML), and meeting at least one of the following conditions:
- Failure to achieve complete remission (CR) after standard induction chemotherapy;
- First CR duration ≤12 months;
- First CR duration >12 months, followed by relapse and failure of at least one line of standard chemotherapy;
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- Relapsed disease after ≥2 prior lines of therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Estimated life expectancy ≥3 months;
- Adequate organ function, defined as:
- Cardiac: left ventricular ejection fraction (LVEF) ≥50% by echocardiography, with no clinically significant ECG abnormalities;
- Renal: serum creatinine ≤2.0 × upper limit of normal (ULN) and creatinine clearance ≥60 mL/min (Cockcroft-Gault);
- Hepatic: ALT and AST ≤3.0 × ULN;
- Total bilirubin ≤2.0 × ULN (≤3.0 × ULN for patients with Gilbert syndrome);
- Oxygen saturation ≥92% on room air;
- Ability to take oral medications and comply with study procedures;
- Willingness to participate and provide written informed consent.
Who cannot join
- Participants meeting any of the following criteria will be excluded:
- Known hypersensitivity to any study drug or its excipients;
- Active central nervous system (CNS) leukemia (patients with prior CNS involvement who achieved complete remission and are clinically stable may be eligible);
- Active, uncontrolled bacterial, viral, or systemic fungal infection;
- Known hereditary bleeding or coagulation disorders, history of non-traumatic bleeding or thromboembolism, or other conditions that may increase bleeding risk;
- Evidence of active infection, including:
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- Hepatitis B virus (HBV) infection with positive HBsAg or HBcAb and HBV DNA >100 copies/mL;
- Hepatitis C virus (HCV) antibody positive with detectable HCV RNA;
- Human immunodeficiency virus (HIV) infection;
- Positive test for syphilis;
- Active bleeding or clinically significant bleeding tendency, including but not limited to:
- Active gastrointestinal bleeding, intracranial hemorrhage, or bleeding in other vital organs;
- Grade ≥3 bleeding event within 4 weeks prior to enrollment (per CTCAE);
- Known hereditary bleeding disorders (e.g., hemophilia);
- Severe platelet dysfunction not correctable;
- Significant cardiovascular disease, including but not limited to:
- New York Heart Association (NYHA) class III-IV heart failure;
- Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;
- Clinically significant ventricular arrhythmias or unexplained syncope (excluding vasovagal or dehydration-related causes);
- Severe cardiomyopathy;
- History of or concurrent other malignancies (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix);
- Clinically significant central nervous system disorders (e.g., epilepsy, stroke, psychiatric disorders) that may affect compliance or safety;
- Participation in another interventional clinical trial within 30 days prior to enrollment;
- Pregnant or breastfeeding women, or subjects planning pregnancy during the study period or within 6 months after the last dose and unwilling to use effective contraception;
- Known or suspected drug abuse or alcohol dependence;
- Requirement for concomitant use of strong CYP3A inhibitors or inducers that cannot be discontinued or dose-adjusted per protocol;
- Any other condition that, in the investigator's opinion, would make the subject unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shenzhen University general hospital
Shenzhen, Guangdong, 0755
Shujiao He, 075521837489, he_shujiao@126.com
About this study
Official title: A Prospective, Single-Arm Study of Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia (Non-M3)
This is a prospective, single-arm, exploratory study evaluating the combination of Bugitinib, Venetoclax, and Cytarabine in adult patients with relapsed or refractory acute myeloid leukemia (AML), excluding M3 subtype. The primary objective is to assess the rate of MRD (Minimal Residual Disease) negativity and the duration of MRD-negative status following treatment. Secondary objectives include evaluating overall response rate (CR/CRi), overall survival, progression-free survival, and safety. Treatment consists of induction therapy with Bugitinib and Venetoclax orally for 28 days combined with Cytarabine intravenously for 7-10 days per cycle. Patients who do not achieve complete remission after the first cycle may receive a second cycle with dose-adjusted Cytarabine. MRD and bone marrow assessments will guide therapy continuation, consolidation, or maintenance. Safety and tolerability will be closely monitored throughout the study.
- Conditions
- Acute Myeloid Leukemia, Relapse/Recurrence
- Being tested
- Bugitinib
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BugitinibDrug
Bugitinib orally once daily, Venetoclax orally once daily with dose escalation to target dose, and Cytarabine intravenously daily.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Description:
Patients in this arm will receive Bugitinib orally once daily, Venetoclax orally once daily with dose escalation to target dose, and Cytarabine intravenously daily.
Induction (Cycle 1, 28 days):
Bugitinib: XX mg orally, Days 1-28 Venetoclax: Gradual escalation to XX mg orally, Days 1-28 Cytarabine: XX mg/m² IV daily, Days 1-7
Cycle 2 (for patients not achieving CR/CRi after Cycle 1):
Bugitinib: same dose orally, Days 1-28 Venetoclax: same dose orally, Days 1-28 Cytarabine: XX mg/m² IV daily, Days 1-10 (dose/duration adjustment based on tolerance and response)
Supportive care including antimicrobial prophylaxis, blood product support, and growth factors will be provided as clinically indicated. Treatment response will be evaluated by bone marrow assessment and MRD testing at the end of each cycle. Receives: Drug: Bugitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD
MRD negativity rate and duration of MRD-negative status
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start21 Apr 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heshujiao, Shenzhen University General Hospital
- Investigators
- Shujiao He, Dr, Principal investigator, Shenzhen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07563179
- Sponsor's protocol ID
- KYLLSY-202505
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 1 May 2026
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-Arm Study of Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia (Non-M3)
- ClinicalTrials.gov ID
- NCT07563179
- Acronym / sponsor ID
- KYLLSY-202505
- Conditions
- Acute Myeloid Leukemia, Relapse/Recurrence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shenzhen University General HospitalUniversity, hospital or other
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 1 May 2026 (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.
This is a prospective, single-arm, exploratory study evaluating the combination of Bugitinib, Venetoclax, and Cytarabine in adult patients with relapsed or refractory acute myeloid leukemia (AML), excluding M3 subtype. The primary objective is to assess the rate of MRD (Minimal Residual Disease) negativity and the duration of MRD-negative status following treatment. Secondary objectives include evaluating overall response rate (CR/CRi), overall survival, progression-free survival, and safety. Treatment consists of induction therapy with Bugitinib and Venetoclax orally for 28 days combined with Cytarabine intravenously for 7-10 days per cycle. Patients who do not achieve complete remission after the first cycle may receive a second cycle with dose-adjusted Cytarabine. MRD and bone marrow assessments will guide therapy continuation, consolidation, or maintenance. Safety and tolerability will be closely monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Drug: BugitinibDescription: Patients in this arm will receive Bugitinib orally once daily, Venetoclax orally once daily with dose escalation to target dose, and Cytarabine intravenously daily. Induction (Cycle 1, 28 days): Bugitinib: XX mg orally, Days 1-28 Venetoclax: Gradual escalation to XX mg orally, Days 1-28 Cytarabine: XX mg/m² IV daily, Days 1-7 Cycle 2 (for patients not achieving CR/CRi after Cycle 1): Bugitinib: same dose orally, Days 1-28 Venetoclax: same dose orally, Days 1-28 Cytarabine: XX mg/m² IV daily, Days 1-10 (dose/duration adjustment based on tolerance and response) Supportive care including antimicrobial prophylaxis, blood product support, and growth factors will be provided as clinically indicated. Treatment response will be evaluated by bone marrow assessment and MRD testing at the end of each cycle. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age 18-70 years (inclusive), regardless of sex;
- Diagnosis of non-M3 acute myeloid leukemia (AML), and meeting at least one of the following conditions:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
- Estimated life expectancy ≥3 months;
- Adequate organ function, defined as:
Key exclusion criteria (27 listed)
- Known hypersensitivity to any study drug or its excipients;
- Active central nervous system (CNS) leukemia (patients with prior CNS involvement who achieved complete remission and are clinically stable may be eligible);
- Active, uncontrolled bacterial, viral, or systemic fungal infection;
- Known hereditary bleeding or coagulation disorders, history of non-traumatic bleeding or thromboembolism, or other conditions that may increase bleeding risk;
- Evidence of active infection, including:
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 |
|---|---|---|
| BugitinibBugitinib orally once daily, Venetoclax orally once daily with dose escalation to target dose, and Cytarabine intravenously daily. | Drug | intervention |
Primary outcome
MRD
Time frame: 2 years
MRD negativity rate and duration of MRD-negative status
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 1 May 2026.
- 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.
Shujiao He, Dr principal investigator
Shenzhen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bugitinib in people with Acute Myeloid Leukemia and Relapse/Recurrence, run by Shenzhen University General Hospital at 1 site in China.
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 17 inclusion and 27 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: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 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.
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 Shujiao He, Dr (075521837489, he_shujiao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRD (time frame: 2 years). 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 1 May 2026.