Clinical Trial Goal
To find out if the combination of inotuzumab ozogamicin and anti-cancer drugs is safe and works well to treat Ph+ ALL that has not yet been treated
You may be able to join this trial if you:
- Are 18 years old or older
- Have Ph+ ALL that has not yet been treated
- Do not have lymphoma in your brain or spinal cord
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Dasatinib is a tyrosine kinase inhibitor that blocks BCR-ABL in certain cells.
Dexamethasone is a drug that reduces inflammation.
Inotuzumab ozogamicin is an antibody-drug conjugate that targets CD22 on certain cells.
Methotrexate and vincristine are chemotherapy (chemo) drugs that block the growth of cancer cells.
You’ll get treatment in cycles that last a month. In each cycle, you'll get:
Dexamethasone is a drug that reduces inflammation.
Inotuzumab ozogamicin is an antibody-drug conjugate that targets CD22 on certain cells.
Methotrexate and vincristine are chemotherapy (chemo) drugs that block the growth of cancer cells.
You’ll get treatment in cycles that last a month. In each cycle, you'll get:
- Dasatinib – Given as a pill that you take by mouth 1 time each day
- Dexamethasone – Given as intravenous (IV) infusions 15 times each cycle
- Inotuzumab ozogamicin – Given as IV infusions 3 times each cycle
- Methotrexate – Given as a shot into the spinal canal 2 times each cycle
- Vincristine – Given as IV infusions
You may continue on to allogeneic (cells from a donor) blood or marrow transplant (BMT) after 2 months of treatment if doctors this it's best for your health. If you do not have a BMT, you will continue treatment for up to 1 year. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 3 years.
The Food and Drug Administration (FDA) has approved all of the drugs used in this trial. Using them in this combination to treat Ph+ ALL is new and unproven.
Contacts
Cancer Clinical Trials Office, 1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu
Wendy Stock, MD, 773-834-8982, PhaseIICRA@medicine.bsd.uchicago
Locations
University of Chicago Medical CenterRECRUITING
Chicago, Illinois
Wendy Stock, MD, 773-834-8982, cancerclinicaltrials@bsd.uchicago.edu
Sponsors
lead: University of Chicago
