Bugitinib Combined With Venetoclax and Cytarabine in Relapsed/Refractory Acute Myeloid Leukemia

NCT07563179 | Recruiting Phase 2 DMC

• 1 other identifier: KYLLSY-202505
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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

Relapse/Recurrence; Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• MRD

  MRD negativity rate and duration of MRD-negative status

  2 years

Study Arms (1)

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.

Drug: Bugitinib

Interventions

Bugitinib DRUG

Bugitinib orally once daily, Venetoclax orally once daily with dose escalation to target dose, and Cytarabine intravenously daily.

intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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:
• 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;

Sponsors & Collaborators

• Shenzhen University General Hospital: lead

Study Sites (1)

Shenzhen University general hospital

Shenzhen, Guangdong, 0755, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shujiao He, Dr

  Shenzhen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shujiao He, Dr

CONTACT

075521837489; he_shujiao@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 1, 2026
• Study Start: April 21, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): June 30, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)