Ixazomib + Chemotherapy for Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This is a phase 1/2 study of a drug called Ixazomib in combination with cytotoxic chemotherapy consisting of Vincristine, Dexamethasone, Asparaginase, and Doxorubicin (VXLD).
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop all current medications, but some medications can be continued up to 24 hours before starting the trial. These include hydroxyurea and certain 'maintenance-style' therapies like vincristine, oral 6-mercaptopurine, oral methotrexate, dexamethasone, and prednisone. However, you cannot be on investigational drugs, anti-GVHD agents, or strong CYP3A4 inducers.
Is ixazomib safe for use in humans?
Ixazomib, also known as Ninlaro, has been shown to have a generally tolerable safety profile in humans, particularly in patients with multiple myeloma. Common side effects include low blood platelet counts, diarrhea, and nausea, with some serious side effects like severe gastrointestinal issues and infections. Close monitoring for these side effects is recommended.12345
What makes the drug Ixazomib unique for treating leukemia?
Who Is on the Research Team?
Terzah Horton, MD
Principal Investigator
Baylor College of Medicine
Are You a Good Fit for This Trial?
This trial is for children and young adults up to 21 years old with relapsed or refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy). Participants must have tried previous therapies, have a certain level of physical ability, and not be breastfeeding. They can't join if they've had too much exposure to anthracyclines, specific CNS diseases, ongoing infections without improvement, significant concurrent illnesses that could affect safety or compliance, DNA fragility syndromes, certain levels of neuropathy, or are on disallowed medications.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ixazomib in combination with chemotherapy drugs including Vincristine, Dexamethasone, Asparaginase, and Doxorubicin to determine the maximum tolerated dose and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ixazomib
Ixazomib is already approved in United States, European Union, Canada, Japan for the following indications:
- Multiple myeloma in combination with lenalidomide and dexamethasone
- Multiple myeloma in combination with lenalidomide and dexamethasone
- Multiple myeloma in combination with lenalidomide and dexamethasone
- Multiple myeloma in combination with lenalidomide and dexamethasone
Find a Clinic Near You
Who Is Running the Clinical Trial?
Therapeutic Advances in Childhood Leukemia Consortium
Lead Sponsor
Takeda
Industry Sponsor
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier
Children's Hospital Los Angeles
Collaborator