Actively Recruiting
Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia
Led by Shenzhen University General Hospital · Updated on 2026-05-01
10
Participants Needed
1
Research Sites
166 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 70 years inclusive
- Diagnosis of non-M3 acute myeloid leukemia (AML)
- Failure to achieve complete remission after standard induction chemotherapy, or first complete remission lasting 12 months or less
- First complete remission longer than 12 months followed by relapse and failure of at least one standard chemotherapy line
- Relapsed disease after two or more prior therapy lines
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Estimated life expectancy of at least 3 months
- Adequate organ function including cardiac (LVEF 60%), renal, hepatic, and oxygen saturation 62% on room air
- Ability to take oral medications and comply with study procedures
- Willingness to provide informed consent
You will not qualify if you...
- Known allergy to study drugs or their ingredients
- Active central nervous system leukemia (except stable prior CNS involvement in remission)
- Active, uncontrolled bacterial, viral, or fungal infections
- Known bleeding or clotting disorders or recent significant bleeding events
- Evidence of active infections including hepatitis B, hepatitis C, HIV, or syphilis
- Active bleeding or clinically significant bleeding tendencies
- Severe cardiovascular disease such as NYHA class III-IV heart failure or recent myocardial infarction
- History or current other cancers except treated basal cell carcinoma or cervical carcinoma in situ
- Significant central nervous system disorders affecting safety or compliance
- Participation in another clinical trial within 30 days
- Pregnancy, breastfeeding, or unwillingness to use effective contraception
- Known or suspected drug or alcohol abuse
- Need for strong CYP3A inhibitors or inducers that cannot be stopped or adjusted
- Any condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shenzhen University general hospital
Shenzhen, Guangdong, China, 0755
Actively Recruiting
Research Team
S
Shujiao He, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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