Dasatinib and Venetoclax in Treating Patients With Philadelphia Chromosome Positive or BCR-ABL1 Positive Early Chronic Phase Chronic Myelogenous Leukemia

• Status: Recruiting
• Trial end date: 2040-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well dasatinib and venetoclax work in treating patients with Philadelphia chromosome positive or BCR-ABL1 positive early chronic phase chronic myelogenous leukemia. Dasatinib and venetoclax may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Dasatinib; Venetoclax

Criteria

Inclusion Criteria:

• Diagnosis of Philadelphia chromosome (Ph)-positive or BCR-ABL positive CML in early chronic phase CML (i.e., time from diagnosis is 12 months); except for hydroxyurea and/or 1 to 2 doses of cytarabine patients, 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)

• Patients with clonal evolution and no other criteria for accelerated phase will be eligible for this study

• Eastern Cooperative Oncology Group (ECOG) performance of 0-2

• Total bilirubin < 1.5 x upper limit normal (ULN)

• Serum glutamate pyruvate transaminase (SGPT) < 3 x ULN

• Creatinine < 1.5 x ULN

• 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

Exclusion Criteria:

• New York Heart Association (NYHA) cardiac class 3-4 heart disease

• 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:

• 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; pregnant or breast-feeding women are excluded; all WOCBP must have a negative pregnancy test prior to first receiving investigational product; if the pregnancy test is positive, the patient must not receive investigational product and must not be enrolled in the study

• Patients in late chronic phase (i.e., time from diagnosis to treatment > 12 months), accelerated or blast phase are excluded; the definitions of CML phases are as follows:

• 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