Clinical Trials /

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

NCT02689440

Description:

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.

Related Conditions:
  • Chronic Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Dasatinib
  • Official Title: Therapy of Early Chronic Phase Chronic Myelogenous Leukemia (CML) With Dasatinib

Clinical Trial IDs

  • ORG STUDY ID: 2015-1040
  • SECONDARY ID: NCI-2016-00362
  • NCT ID: NCT02689440

Conditions

  • Chronic Myelogenous Leukemia

Interventions

DrugSynonymsArms
DasatinibBMS-354825, SprycelDasatinib

Purpose

The goal of this clinical research study is to learn if giving half of the recommended FDA approved dose of dasatinib can help to control CML as effectively as the full dose of dasatinib.

Detailed Description

      Study Drug Administration:

      If you are found to be eligible to take part in this study, you will take dasatinib tablets
      by mouth one (1) time each day. You should take each dose of dasatinib with a meal.

      The dose of dasatinib you receive may be changed if the study doctor thinks it is in your
      best interest.

      Study Visits:

      Every 1-2 weeks for the first 4 weeks, every 2-6 weeks after that for the first 3 months,
      then every 3 months after that during Year 1, and then every 3-6 months until Year 2, blood
      (about 2 teaspoons) will be drawn for routine tests.

      You may have this blood draw more or less often, if the study doctor thinks it is needed.

      If it is more convenient to you and the study doctor agrees, you may be able to have these
      blood draws and physical exams performed at a local lab or by a doctor closer to your home.
      The results of these tests will be sent to the study doctor at MD Anderson for review. The
      study doctor will discuss this option with you.

      At Months 3, 6, 9, and 12, you will have a physical exam and blood (about 2 teaspoons) will
      be drawn to check the status of the disease.

      After the first year, you will have a physical exam every 6-12 months. You may also be
      called to ask if you have had any side effects. Each phone call should take about 5 minutes.

      Length of Study:

      You may continue to take dasatinib for up to 15 years. You will no longer be able to take
      the study drug if the disease gets worse, if intolerable side effects occur, or if you are
      unable to follow study directions.

      Your participation in this study will be over after your last dose of study drug.

      This is an investigational study. Dasatinib is FDA approved and commercially available for
      the treatment of CML. It is considered investigational to give a lower dose of dasatinib to
      treat CML. The study doctor can explain how the study drug is designed to work.

      Up to 100 participants will take part in this study. All will be enrolled at MD Anderson.
    

Trial Arms

NameTypeDescriptionInterventions
DasatinibExperimentalParticipants take Dasatinib tablets by mouth one (1) time each day.
  • Dasatinib

Eligibility Criteria

        Inclusion Criteria:

          1. Diagnosis of Ph-positive or BCR-ABL positive CML in early chronic phase CML (i.e.,
             time from diagnosis 12 months). Except for hydroxyurea, patients must have received
             no or minimal prior therapy, defined as <1 month (30 days) of prior FDA approved TKI.

          2. Clonal evolution defined as the presence of additional chromosomal abnormalities
             other than the Ph chromosome has been 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
             and no other criteria for accelerated phase will be eligible for this study.

          3. ECOG performance of 0-2.

          4. Adequate end organ function, defined as the following: total bilirubin <1.5x ULN,
             SGPT <2.5x ULN, creatinine <1.5x ULN.

          5. 4.4 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:

          1. NYHA cardiac class 3-4 heart disease

          2. Cardiac Symptoms: Patients meeting the following criteria are not eligible unless
             cleared by Cardiology: 1. Uncontrolled angina within 3 months. 2.Diagnosed or
             suspected congenital long QT syndrome. 3. Any history of clinically significant
             ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation,
             or Torsades de pointes). 4. Prolonged QTc interval on pre-entry electrocardiogram (>
             460 msec). 5.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)

          3. Patients with active, uncontrolled psychiatric disorders include: psychosis, major
             depression, and bipolar disorders.

          4. 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.

          5. 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: a.Early chronic phase: time from diagnosis to therapy 12 months. Late
             chronic phase: time from diagnosis to therapy > 12 months. b. Blastic phase: presence
             of 30% blasts or more in the peripheral blood or bone marrow. c.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 109/L
             unrelated to therapy • Documented extramedullary blastic disease outside liver or
             spleen
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Major Molecular Response (MMR)
Time Frame:12 months
Safety Issue:
Description:MMR defined as BCR-ABL transcripts (IS) < 0.1%.

Secondary Outcome Measures

Measure:Complete Cytogenetic Response (CCR)
Time Frame:6 months
Safety Issue:
Description:CCR defined as 0% Ph-positive metaphases, or FISH ≤ 2%, or BCR-ABL transcripts (IS) ≤ 1%.

Details

Phase:Phase 4
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:M.D. Anderson Cancer Center

Trial Keywords

  • Chronic Myelogenous Leukemia
  • CML
  • Ph-positive chronic myelogenous leukemia
  • BCR-ABL positive chronic myelogenous leukemia
  • Dasatinib
  • BMS-354825
  • Sprycel

Last Updated

April 3, 2017