Actively Recruiting
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-04-24
30
Participants Needed
1
Research Sites
229 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
A
Ascentage Pharma Group Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
To find the recommended doses of lisaftoclax and olverembatinib that can be given in combination with decitabine to participants with advanced CML and Ph+ AML.
CONDITIONS
Official Title
A Phase I Study of Decitabine, Lisaftoclax, and Olverembatinib in Patients With Advanced Chronic Myeloid Leukemia and Philadelphia Chromosome-Positive Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with a diagnosis of CML-AP, CML-MBP, or Ph+ AML by WHO 2016 criteria
- Intolerant or resistant to at least one prior BCR::ABL1 tyrosine kinase inhibitor
- Performance status of 3 or less on the ECOG scale
- Adequate liver function: bilirubin less than 1.5 times upper limit of normal unless due to specific conditions
- Liver enzymes (ALT and AST) less than 3 times upper limit of normal unless due to leukemia
- Creatinine clearance of 30 mL/min or higher
- Serum amylase or lipase less than 1.5 times upper limit of normal
- Ability to understand and willing to sign informed consent
- Willingness to use effective contraception during the study and for 6 months after completion
You will not qualify if you...
- Previous treatment with lisaftoclax or olverembatinib
- History of acute or chronic pancreatitis within 1 year
- Active grade III-V heart failure
- Uncontrolled cardiovascular disease, including recent heart attack, stroke, unstable angina, or transient ischemic attack within 6 months
- Low left ventricular ejection fraction
- Diagnosed or suspected congenital long QT syndrome
- Significant arrhythmias such as uncontrolled atrial fibrillation or ventricular tachycardia
- Prolonged QTc interval greater than 480 msec unless corrected
- Venous thromboembolism within the past 3 months (excluding certain line-associated thrombosis)
- Uncontrolled high blood pressure (diastolic >100 mmHg or systolic >150 mmHg)
- Active serious infections not controlled by antibiotics
- Active central nervous system leukemia
- Known HIV infection unless well controlled on treatment
- Known or suspected active hepatitis B or C infection without undetectable viral load
- Prior or concurrent malignancy that may interfere with safety or efficacy assessment
- Use of strong CYP3A or p-glycoprotein inducers within 14 days before enrollment
- Treatment with other investigational antileukemic or chemotherapy agents within 7 days unless recovered
- Inability to swallow
- Pregnant or breastfeeding women
- History of allergic reactions to study drugs or similar agents
- Psychiatric or social conditions limiting compliance with study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nicholas Short, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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