Full Title
Improving EveNt Free Survival by Optimizing FLUdarabine Exposure during LymphodepletioN for CAR T CEll Therapy: a Randomized, Multi-center Study of Children and Young Adults with B-cell Acute Lymphoblastic Leukemia (INFLUENCE)Purpose
CAR T-cell therapy is a type of immunotherapy that teaches a person’s immune cells to find and destroy cancer cells. Fludarabine is a chemotherapy drug given with cyclophosphamide before CAR T-cell therapy. It helps create space for new, healthy cells like CAR T cells to grow and work well.
In this study, researchers are assessing a new way to determine the best dosing of fludarabine. The people in this study are children and young adults getting CAR T-cell therapy for B-cell acute lymphoblastic leukemia (B-ALL). Their cancer has come back or keeps growing despite treatment. They will be getting a CAR T-cell therapy called tisagenlecleucel (Kymriah).
The patients who take part in this study will be randomly assigned to one of these groups:
- Standard fludarabine: Fludarabine given with the standard dosing method, which uses the same amount of drug for everyone based on average data.
- Targeted fludarabine: Pharmacokinetic (PK) targeted dosing of fludarabine. PK is a method to test how the body absorbs, distributes, and gets rid of a drug. Targeted dosing means the blood is tested, and researchers can adjust the dose of a drug based on the PK.
Researchers think that targeted dosing of fludarabine may improve how well tisagenlecleucel works in young people with B-ALL.
Who Can Join
To join this study, there are a few conditions. You or your child must:
- Have B-ALL and be planning to have CAR T-cell therapy with tisagenlecleucel.
- Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
- This study is for children and young adults.
Contact
For more information about this study or to see if you or your child can join, please call 833-MSK-KIDS.