Clinical Trial Goal
To find out if the combination of ibrutinib and blinatumomab is safe and works well to treat relapsed or refractory B-cell ALL
You may be able to join this trial if you:
- Are 18 years old or older
- Have B-cell ALL that has relapsed or is refractory
- Do not have leukemia in your brain or spinal cord
- Have not been treated with ibrutinib or blinatumomab before
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Ibrutinib is a small molecule inhibitor that blocks BTK in certain cells.
Blinatumomab is a bispecific T cell engager (BiTE) antibody that targets CD19 on certain cells.
You’ll get:
Blinatumomab is a bispecific T cell engager (BiTE) antibody that targets CD19 on certain cells.
You’ll get:
- Ibrutinib – A pill that you take by mouth each day.
- Blinatumomab – Given as a continuous intravenous (IV) infusion for 4 weeks at a time. The drug is given by a small pump which you’ll carry with you the whole time. You’ll get a shoulder bag or belt bag which holds the pump and the drug. You will be able to wear regular clothes, walk around, and perform normal daily activities.
You may continue taking ibrutinib for as long as the clinical trial doctors think it's best for your health. You’ll take blinatumomab for about 6 months. The clinical trial doctors will check your health for as long as you are in the trial.
The Food and Drug Administration (FDA) has approved blinatumomab to treat B-cell ALL. Ibrutinib is approved to treat chronic lymphocytic leukemia (CLL). Using these drugs together in this way to treat B-cell ALL is new and unproven.
Locations
University of California Davis Comprehensive Cancer CenterRECRUITING
Sacramento, California
Brian A. Jonas, 916-734-3772, bajonas@ucdavis.edu
Sponsors
collaborator: National Cancer Institute (NCI), collaborator: Pharmacyclics LLC., lead: Brian Jonas
