Actively Recruiting
A Prospective, Single-Arm Study of Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia (Non-M3)
Led by Shenzhen University General Hospital · Updated on 2026-05-01
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of Bugitinib, Venetoclax, and Cytarabine in adults with relapsed or refractory acute myeloid leukemia (AML), excluding the M3 subtype. This exploratory study aims to assess the rate and duration of minimal residual disease (MRD) negativity after treatment. Secondary goals include measuring overall response, survival rates, disease progression, and safety of the treatment combination. Participants will receive induction therapy with Bugitinib and Venetoclax taken orally daily for 28 days, combined with Cytarabine given intravenously for 7 to 10 days per cycle. If complete remission is not achieved after the first cycle, a second cycle with adjusted Cytarabine dosing may be given. Treatment decisions will be guided by MRD and bone marrow assessments, with supportive care provided as needed. Throughout the study, participants will undergo regular bone marrow and MRD testing to evaluate treatment response. Safety and tolerability will be closely monitored during therapy. The study includes follow-up assessments for up to two years to track the duration of MRD negativity and other outcomes. Participants must be adults aged 18 to 70 years with specific AML criteria and adequate organ function to take part in this research.
CONDITIONS
Brief 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, any sex
- Diagnosis of non-M3 acute myeloid leukemia (AML) with one of the following: failure to achieve complete remission after standard chemotherapy, first remission lasting 12 months or less, relapse after remission longer than 12 months with prior chemotherapy failure, or relapsed disease after two or more prior therapies
- ECOG performance status of 0 to 2
- Estimated life expectancy of at least 3 months
- Adequate organ function including cardiac, renal, hepatic, and oxygen saturation criteria
- Ability to take oral medications and comply with study procedures
- Willingness to provide written informed consent
You will not qualify if you...
- Known allergy to any study drug or ingredients
- Active central nervous system leukemia (unless previously treated and stable)
- Active uncontrolled bacterial, viral, or systemic fungal infection
- Known bleeding or clotting disorders or history of significant bleeding or thromboembolism
- Active infection with hepatitis B, hepatitis C, HIV, or syphilis
- Active or significant bleeding issues, including recent major bleeding events
- Significant heart disease including severe heart failure, recent heart attack or surgery, serious arrhythmias, or severe cardiomyopathy
- History or presence of 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
- Pregnant or breastfeeding, or planning pregnancy during study or for 6 months after treatment
- Known or suspected drug or alcohol abuse
- Need for strong CYP3A inhibitors or inducers that cannot be stopped or adjusted
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Induction Cycle 1: 28 days; Cycle 2 (if needed): up to 28 days
Participants receive Bugitinib orally once daily, Venetoclax orally once daily with dose escalation, and Cytarabine intravenously daily. The treatment includes an induction cycle of 28 days and may include a second cycle of up to 28 days if remission is not achieved after the first cycle. Supportive care is provided as needed.
Multiple visits during treatment cycles for medication administration and assessments
Trial Site Locations
Total: 1 location
1
Shenzhen University general hospital
Shenzhen, Guangdong, China, 0755
Actively Recruiting
Research Team
S
Shujiao He, Dr
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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