Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShenzhen University General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-70 years (inclusive), regardless of sex;
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Bugitinib
DrugBugitinib orally once daily, Venetoclax orally once daily with dose escalation to target dose, and Cytarabine intravenously daily.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: interventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
MRD
MRD negativity rate and duration of MRD-negative status
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov