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OncoMatch/Clinical Trials/NCT05007873

ASTX727 and Dasatinib for the Treatment of Newly Diagnosed Philadelphia Chromosome or BCR-ABL Positive Chronic Myeloid Leukemia in Chronic Phase

Is NCT05007873 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dasatinib and Decitabine and Cedazuridine for chronic phase chronic myelogenous leukemia.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT05007873Data as of May 2026

Treatment: Dasatinib · Decitabine and CedazuridineThis 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.

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Extracted eligibility criteria

Cancer type

Chronic Myeloid Leukemia

Biomarker criteria

Required: BCR-ABL1 fusion

BCR-ABL positive CML

Required: ABL1 fusion

Philadelphia chromosome (Ph)-positive

Disease stage

Required: Stage EARLY CHRONIC PHASE

Excluded: Stage LATE CHRONIC PHASE, ACCELERATED PHASE, BLAST PHASE

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: tyrosine kinase inhibitor

Exception: < 1 month (30 days) of prior FDA approved TKI allowed

< 1 month (30 days) of prior Food and Drug Administration (FDA) approved tyrosine kinase inhibitor (TKI)

Cannot have received: cytarabine (cytarabine)

Exception: 1 to 2 doses allowed

1 to 2 doses of cytarabine

Cannot have received: hydroxyurea (hydroxyurea)

Except for hydroxyurea

Lab requirements

Kidney function

creatinine clearance ≥ 30ml/min calculated using modified crokcroft-gault

Liver function

total bilirubin <1.5x uln (unless secondary to gilbert's disease, in which case should be < 2.5x uln), sgpt <3x uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • M D Anderson Cancer Center · Houston, Texas

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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