Trial Using Venetoclax and Navitoclax for Treating Relapsed Acute Lymphoblastic Leukemia
Sponsor: St. Jude Children's Research Hospital
ClinicalTrials ID:NCT05192889
This clinical trial is testing a combination of chemotherapy drugs, venetoclax and navitoclax, in children with acute lymphoblastic leukemia or lymphoma that has returned or not responded to treatment. The study aims to find the best dose and see how well the treatment works.
Patient Parameters
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Program Overview
This study is exploring a new treatment for children with acute lymphoblastic leukemia or lymphoma that has come back or not responded to previous treatments. The trial is testing a combination of chemotherapy drugs, venetoclax and navitoclax, to see if they can help reduce the cancer. The study will also look at how well the treatment is tolerated and how it affects survival rates.
Description
This trial is divided into two main parts: Phase I and Phase II. In the first part, all participants will receive a combination of venetoclax and navitoclax to see how well it works against the cancer. In the second part, the study will test different doses of venetoclax combined with either blinatumomab for patients with CD19-positive leukemia or navitoclax and high-dose cytarabine for those with CD19-negative leukemia.
The main goal is to see if the treatment can help achieve a state where no cancer cells are detectable in the bone marrow after the first phase of treatment. The study will also determine the best dose for future treatments and monitor the safety and effectiveness of the drug combinations.
Participants will receive various medications as part of the treatment, including venetoclax, navitoclax, dexamethasone, vincristine, and others. The study will also involve regular tests and assessments to monitor the participants' health and response to the treatment.
The trial includes specific treatment blocks for different patient groups based on their cancer type and response to initial treatments. Some patients may receive additional therapies, such as radiation, depending on their condition and response to the initial treatment phase.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with relapsed or refractory acute lymphoblastic leukemia or lymphoma with at least 1% cancer cells in the bone marrow.
- Aged between 4 and 30 years old, with specific criteria for those aged 22 to 30.
- Weigh at least 20 kg and able to swallow pills.
- Have a performance score of 60% or higher, indicating they can carry out daily activities.
- Have adequate organ function, including liver, kidney, and heart function.
- Have recovered from previous treatments and meet specific time requirements since last treatment.
- Agree to use contraception during the study and for 30 days after the last treatment dose.
- Meet additional criteria for specific exploratory groups, such as having certain types of leukemia or being unable to tolerate certain therapies.
Exclusion Criteria
- Have known HIV infection or active hepatitis B or C.
- Are pregnant or breastfeeding.
- Are taking certain medications or foods that could interfere with the study drugs.
- Are unable or unwilling to provide informed consent.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | 10065 | New York | New York |
| St. Jude Children's Research Hospital | 38105 | Memphis | Tennessee |
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