21 Participants Needed

Venetoclax + Vyxeos for Leukemia

SP
Overseen BySite Pulblic Contact
Age: < 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Children's Hospital Medical Center, Cincinnati
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

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?

JP

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

I am between 1 and 39 years old.
I've recovered from previous cancer treatments and it's been enough time since my last major therapy.
My leukemia has returned or didn't respond to treatment.
See 2 more

Exclusion Criteria

You have been diagnosed with certain types of leukemia, genetic disorders, or other medical conditions. You are pregnant or breastfeeding, have an uncontrolled infection, have received a high amount of radiation to the chest area, cannot swallow pills, have recently received certain medications or treatments, are currently taking experimental drugs or other anti-cancer medications (with a few exceptions), or are unable to follow the safety monitoring requirements of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

3-4 weeks
3 visits (in-person) for Vyxeos administration

Follow-up

Participants are monitored for safety, tolerability, and response to treatment, including pharmacokinetic analysis and cardiac function assessment.

60 days

What Are the Treatments Tested in This Trial?

Interventions

  • Venetoclax
  • Vyxeos
Trial Overview The study tests combining Venetoclax with Vyxeos (CPX-351) in pediatric and young adult patients. It aims to assess the safety of this combination therapy in those whose acute leukemia has returned or is resistant to standard treatments.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Venetoclax and Vyxeos combinationExperimental Treatment2 Interventions

Venetoclax is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Venclexta for:
🇪🇺
Approved in European Union as Venclyxto for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials
844
Recruited
6,566,000+

Published Research Related to This Trial

Venetoclax is a highly effective treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), achieving response rates of about 80% in clinical trials involving 240 patients from 2011 to 2016.
While venetoclax has an acceptable safety profile, common side effects include neutropenia and diarrhea, and there is a risk of tumor lysis syndrome (TLS), which can be managed through careful dose ramp-up and patient education, leading to no reported TLS events in ongoing trials.
Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia .Brumbaugh Paradis, H., Alter, D., Llerandi, D.[2018]
Venetoclax is an oral medication that selectively inhibits the BCL-2 protein, which helps cancer cells survive, thereby restoring the ability of these malignant cells to undergo programmed cell death (apoptosis).
It has been approved in the USA for treating chronic lymphocytic leukaemia (CLL) in patients with a specific genetic marker (17p deletion) who have already undergone at least one prior therapy, and it is being studied for various other blood cancers and conditions.
Venetoclax: First Global Approval.Deeks, ED.[2018]
Venetoclax is an effective oral treatment for relapsed or refractory chronic lymphocytic leukemia (CLL), showing durable responses and a manageable safety profile in clinical trials, including patients with poor prognostic factors.
In combination with rituximab, venetoclax significantly improved progression-free survival and achieved undetectable minimal residual disease compared to bendamustine plus rituximab, with benefits lasting for at least 36 months.
Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia.Scott, LJ.[2020]

Citations

Venetoclax: Management and Care for Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia . [2018]
Venetoclax: First Global Approval. [2018]
Venetoclax: A Review in Relapsed/Refractory Chronic Lymphocytic Leukemia. [2020]
Venetoclax: A Review in Previously Untreated Chronic Lymphocytic Leukaemia. [2021]
Venetoclax plus low-dose cytarabine in Japanese patients with untreated acute myeloid leukaemia ineligible for intensive chemotherapy. [2022]
[Venetoclax with low-dose cytarabine for patients with untreated acute myeloid leukemia ineligible for intensive chemotherapy: results from the Chinese cohort of a phase three randomized placebo-controlled trial]. [2021]
6-month follow-up of VIALE-C demonstrates improved and durable efficacy in patients with untreated AML ineligible for intensive chemotherapy (141/150). [2022]
Outpatient initiation of venetoclax in patients with acute myeloid leukemia. [2023]
Venetoclax plus low-dose cytarabine in patients with newly diagnosed acute myeloid leukemia ineligible for intensive chemotherapy: an expanded access study in Japan. [2023]
A retrospective comparison of salvage intensive chemotherapy versus venetoclax-combined regimen in patients with relapsed/refractory acute myeloid leukemia (AML). [2022]
Venetoclax, bendamustine, and rituximab in patients with relapsed or refractory NHL: a phase Ib dose-finding study. [2021]
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