RECRUITING

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

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Conditions

Chronic Phase Chronic Myelogenous LeukemiaPhiladelphia Chromosome PositiveBCR-ABL1 Positive Chronic Myelogenous LeukemiaBCR-ABL1 Positive

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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)

Quick Facts

Study Start:2021-10-21
Study Completion:2026-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05007873

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * 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.
  3. * Eastern Cooperative Oncology Group (ECOG) performance of 0-2
  4. * 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.
  5. * 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.
  6. * 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.
  1. * New York Heart Association (NYHA) cardiac class 3-4 heart disease
  2. * Cardiac Symptoms: Patients meeting the following criteria are not eligible unless cleared by Cardiology:
  3. * Uncontrolled angina within 3 months
  4. * Diagnosed or suspected congenital long QT syndrome
  5. * Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).
  6. * Prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (\> 460 msec)
  7. * History of significant bleeding disorder unrelated to cancer, including unless cleared by hematologist or hemato-oncologist
  8. * Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease)
  9. * Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies)
  10. * Patients with active, uncontrolled psychiatric disorders include: psychosis, major depression, and bipolar disorders
  11. * Subject is known to be positive for human immunodeficiency virus (HIV) (HIV testing is not required)
  12. * Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
  13. * Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
  14. * 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
  15. * 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.
  16. * Patients in late chronic phase (i.e., time from diagnosis to treatment \> 12 months), accelerated (except as noted in inclusion criteria 4.1) or blast phase are excluded. The definitions of CML phases are as follows:
  17. * Early chronic phase: time from diagnosis to therapy ≤ 12 months
  18. * Late chronic phase: time from diagnosis to therapy \> 12 months
  19. * Blastic phase: presence of 30% blasts or more in the peripheral blood or bone marrow
  20. * Accelerated phase CML: presence of any of the following features:
  21. * Peripheral or marrow blasts 15% or more
  22. * Peripheral or marrow basophils 20% or more
  23. * Thrombocytopenia \< 100 x 10\^9/L unrelated to therapy
  24. * Documented extramedullary blastic disease outside liver or spleen

Contacts and Locations

Principal Investigator

Elias Jabbour
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Elias Jabbour, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-21
Study Completion Date2026-10-30

Study Record Updates

Study Start Date2021-10-21
Study Completion Date2026-10-30

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Phase Chronic Myelogenous Leukemia
  • Philadelphia Chromosome Positive
  • BCR-ABL1 Positive Chronic Myelogenous Leukemia
  • BCR-ABL1 Positive