Study on Decitabine, Venetoclax, and Ponatinib for Treating Philadelphia Chromosome-Positive Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04188405

Provider View

This clinical trial is testing a combination of three drugs—decitabine, venetoclax, and ponatinib—to see how well they work together in treating certain types of leukemia that are positive for the Philadelphia chromosome.

Patient Parameters

Program Overview

This study is exploring how well a combination of three drugs—decitabine, venetoclax, and ponatinib—works in treating specific types of leukemia that have the Philadelphia chromosome. These drugs work in different ways to stop cancer cells from growing and spreading. Decitabine is a chemotherapy drug that stops cancer cells from dividing. Venetoclax blocks a protein that cancer cells need to survive, and ponatinib blocks enzymes that help cancer cells grow. The goal is to see if using these drugs together can better control the leukemia.

Description

The main goal of this study is to find out how effective the combination of decitabine, venetoclax, and ponatinib is in achieving complete remission, where no signs of cancer are found. Researchers will also look at other outcomes, such as how long patients stay free from cancer and overall survival rates. They will also see how many patients can proceed to a stem cell transplant and check the safety of the drug combination.

Patients will take ponatinib by mouth daily, venetoclax by mouth daily, and receive decitabine through an IV over 60 minutes. The treatment cycles repeat every 28 days for up to 24 cycles, as long as the disease does not progress and side effects are manageable. Some patients may start with ponatinib alone before adding the other drugs. After finishing the treatment, patients will have follow-up visits to monitor their health.

Eligibility Criteria

Inclusion Criteria

  • Have Philadelphia chromosome-positive acute myeloid leukemia (AML) or certain phases of chronic myelogenous leukemia (CML).
  • Both newly diagnosed and those whose cancer has returned or not responded to treatment are eligible.
  • Be in relatively good health with a performance status score of 3 or less.
  • Have acceptable liver and kidney function as shown by specific blood tests.
  • Be able to swallow pills.
  • Agree to sign an informed consent form.

Exclusion Criteria

  • Have an active serious infection not controlled by antibiotics.
  • Have had acute pancreatitis in the past 6 months or have chronic pancreatitis.
  • Have very high triglyceride levels.
  • Have another active cancer that is expected to shorten life to less than a year.
  • Have severe heart problems or uncontrolled high blood pressure.
  • Have consumed grapefruit, Seville oranges, or star fruit within 3 days before starting venetoclax.
  • Have taken other investigational or chemotherapy drugs within 7 days before starting the study, unless fully recovered from side effects.
  • Pregnant or breastfeeding women are not eligible. Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study. Men must also agree to use effective birth control methods.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.