ASTX727 and Dasatinib for Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase [USA]

Study title

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

Scientific title

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)

Type of study

First line trial

Phase

2

Current status

Recruiting

Other trial ID

2021-0271

What is the purpose of the study

This trial studies the effect of the combination of decitabine and cedazuridine (ASTX727) and dasatinib in treating patients with newly diagnosed Philadelphia chromosome or BCR-ABL positive CML in chronic phase.

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. Giving ASTX727 and dasatinib may work better in treating patients with Philadelphia chromosome-positive CML or BCR-ABL positive CML in chronic phase than dasatinib alone.

What will happen during the study

Patients will receive dasatinib orally once daily on days 1-28 (3 cycles). Beginning with cycle 4, patients also receive decitabine and cedazuridine (ASTX727) orally once daily on days 1-3. Cycles repeat every 28 days for up to 3 years.

Key inclusion criteria

This study includes patients of all sexes who:

  • are aged 18 years or older.
  • have been newly diagnosed with Philadelphia chromosome (Ph+) or BCR-ABL1 positive CML in early chronic phase (CML-CP) within 12 months of study entry. 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).
  • have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2.
  • have adequate end organ function as defined in the study protocol.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • have New York Heart Association (NYHA) cardiac class 3-4 heart disease.
  • have active, uncontrolled psychiatric disorders.
  • are known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required).

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

October 2024

Where can I find additional information

You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health

Study sponsor

M.D. Anderson Cancer Center in collaboration with the National Cancer Institute (NCI) and Astex Pharmaceuticals, Inc.

Scientific lead / contact

Elias Jabbour, M D Anderson Cancer Center

Principal investigator

Elias Jabbour, M D Anderson Cancer Center

Study centers / principal investigators

M D Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator: Elias Jabbour