Actively Recruiting
ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase
Led by M.D. Anderson Cancer Center · Updated on 2026-02-18
70
Participants Needed
1
Research Sites
262 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial studies the effect of ASTX727 and dasatinib in treating patients with newly diagnosed Philadelphia chromosome or BCR-ABL positive chronic myeloid leukemia in chronic phase. Philadelphia chromosome positive and BCR-ABL positive are types of genetic mutations (changes). Chemotherapy drugs, such as ASTX727, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. ASTX727 and dasatinib may help to control Philadelphia chromosome-positive chronic myeloid leukemia or BCR-ABL positive chronic myeloid leukemia in chronic phase.
CONDITIONS
Official Title
ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Philadelphia chromosome-positive or BCR-ABL positive chronic myeloid leukemia in early chronic phase (within 12 months of diagnosis)
- No or minimal prior therapy, defined as less than 1 month of prior FDA-approved tyrosine kinase inhibitor treatment except hydroxyurea or 1 to 2 doses of cytarabine
- Patients with clonal evolution only at diagnosis without other accelerated phase criteria are eligible
- Eastern Cooperative Oncology Group performance status of 0 to 2
- Adequate organ function: total bilirubin less than 1.5 times upper limit normal (ULN) unless Gilbert's disease, SGPT less than 3 times ULN, and creatinine clearance 30 mL/min or higher
- Signed informed consent
- Males must be sterile or agree to use effective contraception during the study and for 3 months after last treatment
You will not qualify if you...
- New York Heart Association cardiac class 3 or 4 heart disease
- Uncontrolled angina within 3 months unless cleared by cardiology
- Diagnosed or suspected congenital long QT syndrome
- History of serious ventricular arrhythmias
- Prolonged corrected QT interval greater than 460 msec on ECG
- Significant bleeding disorders unless cleared by hematologist
- Active uncontrolled psychiatric disorders such as psychosis, major depression, or bipolar disorder
- Known HIV positive status
- Uncontrolled infections or chronic hepatitis B or C requiring treatment
- Pregnant or breastfeeding women
- Women of childbearing potential must use effective birth control and have negative pregnancy test prior to enrollment
- Late chronic phase disease (diagnosis to treatment over 12 months), accelerated phase or blast phase CML
- Accelerated phase features including blasts 15% or more, basophils 20% or more, thrombocytopenia under 100 x 10^9/L unrelated to therapy, or extramedullary blastic disease outside liver or spleen
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
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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