ASTX727 and Dasatinib for Newly Diagnosed CML
This study is testing a combination of two drugs, ASTX727 (decitabine and cedazuridine) and dasatinib, for people newly diagnosed with chronic myeloid leukemia (CML) that is Philadelphia chromosome or BCR-ABL positive. These are specific genetic changes in the cancer cells. Dasatinib works by blocking enzymes that help cancer cells grow. ASTX727 is a chemotherapy drug that aims to stop cancer cell growth or spread. The main goal is to see how many participants achieve a specific molecular response (MR4) after 6 months. You can join if you have newly diagnosed CML in its early chronic phase and have received little to no prior treatment. The study plans to enroll 70 participants, but its current status is unclear.
- Study design
- This is an interventional study with an estimated enrollment of 70 participants. It is testing the effect of two drugs given together.
- What's involved
- Participants will take dasatinib daily. Starting in cycle 4, they will also take decitabine and cedazuridine for 3 days each cycle. Cycles repeat every 28 days for up to 3 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess molecular response at 3, 6, 12, 18, 24, and 36 months, and sustained response for 3 years and more.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT05007873
ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase
Active, Not Recruiting
PHASE2All AgesInterventionalTreatmentM.D. Anderson Cancer CenterInvestigator-initiated
~39 participants
Updated 2026-08-03 on ClinicalTrials.gov
What's tested:DasatinibDecitabine and Cedazuridine
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of molecular response 4 (MR4)
Measured over At 6 months
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Elias Jabbour · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Diagnosis of Philadelphia chromosome (Ph)-positive or BCR-ABL positive CML in early chronic phase CML (i.e., time from diagnosis ≤12 months). Except for hydroxyurea and/or 1 to 2 doses of cytarabine patients must have received no or minimal prior therapy, defined as \< 1 month (30 days) of prior Food and Drug Administration (FDA) approved tyrosine kinase inhibitor (TKI)
Clonal evolution defined as the presence of additional chromosomal abnormalities other than the Ph chromosome has historically been included as a criterion for accelerated phase. However, patients with clonal evolution as the only criterion of accelerated phase have a significantly better prognosis, and when present at diagnosis may not impact the prognosis at all. Thus, patients with clonal evolution at diagnosis (early disease) and no other criteria for accelerated phase will be eligible for this study.
Eastern Cooperative Oncology Group (ECOG) performance of 0-2
Adequate end organ function, defined as the following: total bilirubin \<1.5x ULN (unless secondary to Gilbert's disease, in which case should be \< 2.5x ULN), SGPT \<3x ULN, creatinine clearance ≥ 30mL/min calculated using modified Crokcroft-Gault.
Patients must sign an informed consent indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.
Males must be surgically or biologically sterile or agree to use an adequate method of contraception during the study until 3 months after the last treatment.
Early chronic phase: time from diagnosis to therapy ≤ 12 months
Late chronic phase: time from diagnosis to therapy \> 12 months
Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow
Accelerated phase CML: presence of any of the following features:
Peripheral or marrow blasts 15% or more
Peripheral or marrow basophils 20% or more
Thrombocytopenia \< 100 x 10\^9/L unrelated to therapy
Documented extramedullary blastic disease outside liver or spleen
Exclusion
New York Heart Association (NYHA) cardiac class 3-4 heart disease
Cardiac Symptoms: Patients meeting the following criteria are not eligible unless cleared by Cardiology:
Uncontrolled angina within 3 months
Diagnosed or suspected congenital long QT syndrome
Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).
Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\> 460 msec)
History of significant bleeding disorder unrelated to cancer, including unless cleared by hematologist or hemato-oncologist
Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
Patients with active, uncontrolled psychiatric disorders include: psychosis, major depression, and bipolar disorders
Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required)
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface \[HBs\] antigen negative-, anti-HBs antibody positive and anti-hepatitis B core \[HBc\] antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate
Women of pregnancy potential must practice an effective method of birth control during the course of the study, in a manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential (WOCBP) must be advised of the importance of avoiding pregnancy during trial participation and the potential risk factors for an unintentional pregnancy. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Women must continue birth control for the duration of the trial and at least 3 months after the last dose of study drug.
What this trial measures
- Rate of molecular response 4 (MR4)At 6 months
Will be estimated with 95% credible intervals. The association between molecular responses and demographic/ clinical characteristics will be examined by Wilcoxon's rank sum test or Fisher's exact test.