Actively Recruiting
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
Led by M.D. Anderson Cancer Center · Updated on 2026-05-06
50
Participants Needed
1
Research Sites
595 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
To learn if asciminib can help to control CML. The safety and effects of this drug will also be studied.
CONDITIONS
Official Title
Phase II Study Assessing Efficacy and Safety of Asciminib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with Philadelphia chromosome-positive or BCR::ABL1 positive chronic myeloid leukemia in early chronic phase (diagnosed within 12 months)
- Prior treatment with hydroxyurea, 1 to 2 doses of cytarabine, or FDA-approved tyrosine kinase inhibitors for less than 30 days allowed
- Participants with additional chromosomal abnormalities at diagnosis but no accelerated phase criteria
- ECOG performance status of 2 or less
- Adequate organ function: total bilirubin ≤1.5x upper limit of normal (ULN) unless Gilbert's disease, SGPT or SGOT ≤3x ULN, creatinine clearance ≥30 mL/min
- Ability to understand and sign informed consent
- Use of effective contraception for women of childbearing potential and men during and after study participation as specified
- Participants with chronic hepatitis B with undetectable viral load on suppressive therapy
- Participants with treated hepatitis C infection cured or with undetectable viral load if on treatment
- Treated brain metastases with no progression on follow-up imaging
- Prior or concurrent malignancies not interfering with study assessments
- Cardiac function classified as NYHA class 2B or better
You will not qualify if you...
- Prior treatment exceeding 30 days with FDA-approved tyrosine kinase inhibitors or more than 2 doses of cytarabine
- Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) before study entry
- Unresolved adverse events from prior anti-cancer therapy greater than Grade 1 except alopecia
- Use of other investigational agents
- Allergic reactions to asciminib or similar compounds
- NYHA cardiac class 3 or 4 heart disease
- Uncontrolled angina within 3 months or significant ventricular arrhythmias
- Prolonged QTc interval (>460 msec) on ECG
- Significant bleeding disorders unless cleared by a hematologist
- Active uncontrolled psychiatric disorders or cognitive impairment limiting compliance
- Active uncontrolled infections or detectable chronic hepatitis B or C viral load requiring treatment
- Pregnant or breastfeeding women
- Late chronic phase (diagnosis to treatment >12 months), accelerated phase (except as allowed), or blast phase CML as defined by specific criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
E
Elias Jabbour, 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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