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

Sponsor
Shenzhen University General Hospital
Study ID
NCT07563179
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
May 1, 2026
Start date
Apr 21, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: intervention
    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.

Primary Outcome Measure

MRD [ Time Frame: 2 years ]

Central Contacts

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