Venetoclax + Navitoclax for Acute Lymphoblastic Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment plan for children with acute lymphoblastic leukemia or lymphoma that hasn't responded to other treatments. It combines two oral drugs, venetoclax and navitoclax, with other chemotherapy medications to evaluate their effectiveness against this cancer. The study aims to determine the best dose and assess patient response to this combination. It suits children who have tried other treatments without success and can take pills. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering a chance to be among the first to receive this new combination therapy.
Do I have to stop taking my current medications for the trial?
The trial requires you to stop taking certain medications, specifically moderate or strong CYP3A inhibitors and inducers, within a few days before starting the trial. You should also avoid grapefruit, Seville oranges, and star fruit. It's best to discuss your current medications with the trial team to see if any need to be adjusted.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of venetoclax and navitoclax is being tested for safety and effectiveness in treating relapsed or refractory acute lymphoblastic leukemia (rALL). In previous studies, all patients experienced some side effects, known as adverse events. For more serious side effects, classified as Grade 3 or 4, the rate was 89%. These side effects are common with many cancer treatments and are considered when doctors determine safe doses.
Despite these side effects, the treatment has demonstrated positive responses in both children and adults with rALL, reducing cancer cells in some patients. Importantly, no major issues arose with how the drugs interacted in the body, allowing venetoclax and navitoclax to be used safely together.
Overall, while side effects exist, this treatment is considered manageable, meaning most patients can handle them with medical support. The goal is to balance side effects with the potential benefits of treating rALL.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for Acute Lymphoblastic Leukemia (ALL) because they introduce a new approach to tackling the disease. Venetoclax and Navitoclax target and inhibit proteins like BCL-2 that help cancer cells survive, which is different from traditional chemotherapy that attacks rapidly dividing cells indiscriminately. This targeted action could potentially lead to fewer side effects and improved effectiveness against resistant cancer cells. Additionally, the combination of these drugs with other agents like Blinatumomab and Dasatinib might enhance the overall treatment outcome by addressing multiple pathways that contribute to leukemia progression. This multi-faceted approach could offer hope for patients with limited options, especially those who have relapsed.
What evidence suggests that this trial's treatments could be effective for acute lymphoblastic leukemia?
Research has shown that the combination of venetoclax and navitoclax may effectively treat acute lymphoblastic leukemia (ALL) that has returned or is not responding to treatment. In this trial, participants will receive venetoclax and navitoclax as part of different treatment blocks. Studies have found that nearly half of the patients achieved complete remission (CR), meaning no cancer cells were detected, after receiving this treatment. Specifically, 44% of patients undergoing a second round of treatment achieved complete remission. This combination targets proteins that help cancer cells survive, potentially enhancing treatment effectiveness. Early results suggest that adding these drugs to chemotherapy can restore treatment effectiveness in children. Overall, the evidence supports venetoclax and navitoclax as promising options for patients with relapsed or refractory ALL.13678
Who Is on the Research Team?
Seth E. Karol, MD
Principal Investigator
St. Jude Children's Research Hospital
Are You a Good Fit for This Trial?
This trial is for children and young adults aged 4 to under 30 with relapsed or refractory acute lymphoblastic leukemia/lymphoma. They must have certain levels of disease in the bone marrow or blood, be able to swallow pills, have no severe heart issues, and not have had certain recent treatments. Those with Down Syndrome are eligible only for specific parts of the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Block 1 Therapy
Participants receive combination chemotherapy with venetoclax and navitoclax, along with other agents, to evaluate activity in relapsed or refractory acute lymphoblastic leukemia or lymphoma.
Block 2 Therapy
Participants receive either Block 2A or Block 2B therapy based on CD19 status, involving venetoclax combinations with either blinatumomab or high-dose cytarabine and navitoclax.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of minimal residual disease and overall survival.
What Are the Treatments Tested in This Trial?
Interventions
- Venetoclax and Navitoclax
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Jude Children's Research Hospital
Lead Sponsor
AbbVie
Industry Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois