Venetoclax + Vyxeos for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This study evaluates the safety and tolerability of combining venetoclax with Vyxeos (CPX-351) in pediatric and young adult patients with acute leukemia that has come back or not responded to treatment.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but you cannot be on other anti-cancer agents, except for certain exceptions like intrathecal agents or hydroxyurea.
Is the combination of Venetoclax and Vyxeos safe for humans?
Venetoclax has been shown to have an acceptable safety profile in patients with chronic lymphocytic leukemia and acute myeloid leukemia, with common side effects including low potassium levels, vomiting, and constipation. The safety of Vyxeos (a combination of daunorubicin and cytarabine) is not specifically detailed in the provided research, but Venetoclax has been studied in combination with other treatments and found to be manageable.12345
What makes the drug combination of Venetoclax and Vyxeos unique for treating leukemia?
The combination of Venetoclax and Vyxeos is unique because Venetoclax is a targeted therapy that inhibits a protein helping cancer cells survive, while Vyxeos is a liposomal formulation of two chemotherapy drugs, daunorubicin and cytarabine, designed to improve delivery and effectiveness. This combination aims to enhance treatment outcomes by using both targeted and traditional chemotherapy approaches.16789
What data supports the effectiveness of the drug Venetoclax for leukemia?
Venetoclax has shown effectiveness in treating chronic lymphocytic leukemia (CLL), achieving high response rates and prolonging progression-free survival when used alone or in combination with other drugs. It has also been studied in combination with low-dose cytarabine for acute myeloid leukemia, showing a trend towards improved survival.1241011
Who Is on the Research Team?
John Perentesis, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Are You a Good Fit for This Trial?
This trial is for young patients aged 1-39 with acute leukemia that's relapsed or hasn't responded to treatment. They should have recovered from previous therapies and not have certain other health conditions like Fanconi Anemia or Wilson's Disease, be pregnant, breastfeeding, or unable to swallow pills.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single course of venetoclax and Vyxeos. Venetoclax is given daily with a 3-day ramp-up, and Vyxeos is administered intravenously on Days 1, 3, and 5.
Follow-up
Participants are monitored for safety, tolerability, and response to treatment, including pharmacokinetic analysis and cardiac function assessment.
What Are the Treatments Tested in This Trial?
Interventions
- Venetoclax
- Vyxeos
Venetoclax is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Medical Center, Cincinnati
Lead Sponsor