Study on Dasatinib and Venetoclax for Treating Early Chronic Phase Chronic Myelogenous Leukemia with Philadelphia Chromosome or BCR-ABL1 Positive

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02689440

Provider View

This clinical trial is exploring how well the combination of dasatinib and venetoclax works in treating patients with early chronic phase chronic myelogenous leukemia (CML) that is Philadelphia chromosome positive or BCR-ABL1 positive. These drugs may help stop the growth of cancer cells by blocking certain enzymes needed for cell growth.

Patient Parameters

Program Overview

This study is testing the effectiveness of two drugs, dasatinib and venetoclax, in treating patients with early chronic phase chronic myelogenous leukemia (CML) that is positive for the Philadelphia chromosome or BCR-ABL1. The goal is to see if these drugs can help stop the growth of cancer cells by blocking specific enzymes they need to grow.

Description

The main goal of this study is to find out how many patients with newly diagnosed chronic phase chronic myeloid leukemia (CML) achieve a major molecular response after 12 months of treatment with dasatinib alone or in combination with venetoclax. Initially, patients will take dasatinib daily, and after three months, they will also start taking venetoclax for a period of three years, unless they experience disease progression or unacceptable side effects.

Secondary goals include measuring the rate of deep molecular response at various time points, assessing the duration of response, and evaluating the safety of the drug combination. The study will also look at how long patients can remain in remission without treatment, how long it takes for the disease to progress, and overall survival rates.

Participants will take dasatinib daily for up to 15 years, and after three months, they will add venetoclax to their treatment for three years, unless they experience disease progression or unacceptable side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Philadelphia chromosome positive or BCR-ABL1 positive chronic myelogenous leukemia (CML) in early chronic phase (diagnosed within the last 12 months).
  • Minimal prior treatment, defined as less than one month of previous therapy with FDA-approved tyrosine kinase inhibitors (TKIs), except for hydroxyurea or 1-2 doses of cytarabine.
  • Patients with additional chromosomal abnormalities (clonal evolution) but no other signs of accelerated phase are eligible.
  • Good overall health with an ECOG performance status of 0-2.
  • Normal liver and kidney function as indicated by specific blood tests.
  • Must sign an informed consent form acknowledging the investigational nature of the study.

Exclusion Criteria

  • Severe heart disease, including class 3-4 heart failure or recent uncontrolled angina.
  • History of significant heart rhythm problems or prolonged QT interval on an ECG.
  • Significant bleeding disorders unrelated to cancer.
  • Active, uncontrolled psychiatric disorders such as psychosis or major depression.
  • Positive for HIV or active, uncontrolled infections.
  • Chronic hepatitis B or C requiring treatment.
  • Women who are pregnant or breastfeeding, or women of childbearing potential not using effective birth control.
  • Patients in late chronic phase (diagnosed more than 12 months ago), accelerated phase, or blast phase CML.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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