Clinical Trial Goal
To find out:
- The highest dose of ruxolitinib that is safe to give with standard chemo
- If the combination of ruxolitinib and standard chemo is safe and works well to treat high-risk ALL that has not yet been treated in young adults
You may be able to join this trial if you:
- Are 18 – 39 years old
- Have high-risk ALL that doctors consider Philadelphia chromosome-like (Ph-like)
- Have had little or no treatment for the leukemia
- Have leukemia cells that have an alteration or change in the JAK pathway. Your doctor can tell you this
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Cyclophosphamide, cytarabine, doxorubicin, mercaptopurine, pegaspargase, thioguanine and vincristine are chemo drugs that block the growth of cancer cells.
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Ruxolitinib is a small molecule inhibitor that blocks JAK1 and JAK2 in certain cells.
Everyone will get standard chemo for about 1 month before joining the trial.
Then, you'll get:
Rituximab is a monoclonal antibody that targets CD20 on certain cells.
Ruxolitinib is a small molecule inhibitor that blocks JAK1 and JAK2 in certain cells.
Everyone will get standard chemo for about 1 month before joining the trial.
Then, you'll get:
- Cyclophosphamide – Given as intravenous (IV) infusions 1 time each month for 2 months, then you'll have 3 months off, then 1 time each month for 1 more month
- Cytarabine – Given as IV infusions or as shots under your skin 3 times each week for 2 weeks of each month for 2 months, then you'll have 3 months off, then 4 times each week for 2 weeks
- Dexamethasone – Given as IV infusions or as a pill you take by mouth 1 time each day for 2 weeks during the fifth month, then starting the seventh month for the first 5 days of each month for up to 3 years
- Doxorubicin – Given as IV infusions 1 time each week for the first 3 weeks of the fifth month
- Mercaptopurine – A pill that you take by mouth for the first 2 weeks of each month for 2 months, then 1 time each day for up to 3 years
- Methotrexate –
- Given as IV infusions 5 times over 2 months during the third and fourth month
- Given through a needle in your lower back (lumbar puncture) 17 times over 1.5 years
- A pill that you take by mouth about 1 time each week for up to 3 years
- Pegaspargase – Given as IV infusions or as a shot into your muscle 6 - 8 times over 6 months
- Rituximab – Given as IV infusions 1 time each week for the first 2 weeks of each month for 2 months, then 2 times each month every other month for 4 months. Only patients that have leukemia cells with CD20 marker (CD20+) will get this
- Ruxolitinib – A pill that you take by mouth for the first 2 weeks of each month for 6 months. The dose you'll get depends on when you start the trial and how safe it has been
- Thioguanine – A pill that you take by mouth 1 time each day for 2 weeks during the sixth month
- Vincristine – Given as IV infusions 1 time each week for the last 2 weeks of each month for 2 months, then 2 - 3 times each month for 4 months, then 1 time each month for up to 3 years
You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for as long as you're in the trial.
The Food and Drug Administration (FDA) has approved ruxolitinib to treat myelofibrosis and all of the other drugs used in this trial to treat ALL. Using them together in this way to treat high-risk ALL that has not yet been treated in young adults is new and unproven.
Locations
University of Chicago Medical CenterRECRUITING
Chicago, Illinois
Howie Weiner, (773) 702-2084, hweiner@medicine.bsd.uchicago.edu
The University of Texas Southwestern Medical CenterACTIVE_NOT_RECRUITING
Dallas, Texas
Sponsors
collaborator: Incyte Corporation, lead: University of Chicago
