RecruitingPhase 2NCT05007873

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

Phase II Study Assessing Safety and Clinical Activity of the Combination of ASTX727 With Dasatinib in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP)


Sponsor

M.D. Anderson Cancer Center

Enrollment

70 participants

Start Date

Oct 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — ASTX727 (a pill form of decitabine, a chemotherapy), dasatinib (a targeted therapy), and another agent — as a new first-line treatment for people with a type of leukemia called Philadelphia chromosome-positive Chronic Myeloid Leukemia (CML) in the early chronic phase. **You may be eligible if...** - You have been newly diagnosed with CML that is Philadelphia chromosome-positive (Ph+) or BCR-ABL positive - Your diagnosis is within the past 12 months - You have received little or no prior treatment (less than 1 month of an FDA-approved TKI drug) **You may NOT be eligible if...** - You have had CML for more than 12 months before starting the study - You have already received significant prior treatment for CML (more than 1 month of a TKI) - Your leukemia has progressed beyond the early chronic phase Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDasatinib

Given PO

DRUGDecitabine and Cedazuridine

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT05007873


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