Actively Recruiting
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
Led by M.D. Anderson Cancer Center · Updated on 2026-02-17
40
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open label, phase 2 study investigating asciminib in patients previously treated with one line of TKI therapy.
CONDITIONS
Official Title
Phase II Study of Asciminib for Second-line Treatment of Chronic Phase Chronic Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic phase chronic myeloid leukemia
- Received one prior line of tyrosine kinase inhibitor therapy
- History of treatment failure defined by specific molecular or cytogenetic criteria or mutation development
- Eastern Cooperative Oncology Group (ECOG) performance status 2 or less
- Adequate organ function with specified limits on liver enzymes, bilirubin, lipase, alkaline phosphatase, and kidney function
- Agreement to use adequate contraception for women of childbearing potential and men during and after study participation
You will not qualify if you...
- History of T315I mutation
- New York Heart Association (NYHA) Class III or IV heart failure or left ventricular ejection fraction less than 40%
- Recent myocardial infarction within 6 months, unstable angina, or serious uncontrolled arrhythmias
- Corrected QT interval greater than 450 milliseconds or long QT syndrome or related risk factors
- Use of medications that prolong QT interval that cannot be safely stopped
- Known active infection with HIV or Hepatitis B or C
- Conditions affecting oral drug absorption
- Nursing women, positive pregnancy test, or unwillingness to maintain contraception
- History of acute or chronic pancreatitis within 1 year
- Low neutrophil or platelet counts below specified limits
- Other active malignancy within 2 years except certain skin or in situ cancers
- Significant medical or psychiatric conditions that would interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
G
Ghayas Issa, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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