Clinical Trial Goal
To find out if ruxolitinib given before and after allogeneic BMT to treat myelofibrosis is safe and works well to prevent GVHD
You may be able to join this trial if you:
- Are 18 years old or older
- Have myelofibrosis
- Have not had an allogeneic BMT
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
Ruxolitinib is a small molecule inhibitor that blocks JAK1 and JAK2 in certain cells.
First, you'll get ruxolitinib, a pill that you take by mouth 1 time each day for 2 months. You’ll stop taking it about 4 days before transplant.
Then, you’ll get 1 of 2 types of treatment. Your doctor and the clinical trial doctors will choose which type you get based on what they think is best for your health:
First, you'll get ruxolitinib, a pill that you take by mouth 1 time each day for 2 months. You’ll stop taking it about 4 days before transplant.
Then, you’ll get 1 of 2 types of treatment. Your doctor and the clinical trial doctors will choose which type you get based on what they think is best for your health:
- Standard – Standard chemotherapy (chemo) and ruxolitnib
- Reduced intensity – Reduced intensity chemo and ruxolitnib
If your doctors choose standard treatment, you’ll get:
- Busulfan – Given as intravenous (IV) infusions for 4 days
- Cyclophosphamide – Given as IV infusions for 2 days
- Fludarabine – Given as IV infusions for 3 days. Only people having a transplant using umbilical cord blood get this
If your doctors choose reduced intensity treatment, you’ll get:
- Fludarabine – Given as IV infusions for 5 days
- Melphalan – Given as IV infusions for 2 days
- Total body irradiation (TBI) – A treatment done 1 time to get your body ready for transplant. Only people having a transplant using umbilical cord blood get this
On transplant day, you’ll get blood-forming cells from your donor through an IV infusion.
After transplant, you’ll get standard treatment to prevent GVHD. You’ll also get:
- Ruxolitinib – A pill that you take by mouth 1 time each day for about 1.5 years
The clinical trial doctors will check your health for up to 5 years.
The Food and Drug Administration (FDA) has approved ruxolitinib to treat myelofibrosis. Using it before and after allogeneic BMT it to prevent GVHD is new and unproven. The FDA has approved all the other drugs in this study.
Locations
Fred Hutch/University of Washington Cancer ConsortiumRECRUITING
Seattle, Washington
Rachel B. Salit, 206-667-1317, rsalit@fredhutch.org
Sponsors
lead: Fred Hutchinson Cancer Center
