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.
∙ 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;
⁃ 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.