What we are studying
The purpose of this study is to test the safety and tolerability of ruxolitinib at different dose levels in combination with decitabine in patients with accelerated or blast phase Myeloproliferative Neoplasm (MPN), which is a group of diseases of the bone marrow in which excess cells are produced. You may qualify to take part in this research study because you have a MPN blood disorder called myelofibrosis (MF), essential thrombocythemia (ET), or polycythemia vera (PV) that is accelerated or blast phase. Accelerated (10–19% blasts in the blood or bone marrow) and blast phase MPN has been a difficult disease to treat. The term “blasts” refers to immature cells found in bone marrow. They are not fully developed, and therefore, do not yet carry out any particular function within the body. We want to find out what effects, good and/or bad it has on you and your disease.
Ruxolitinib is a drug that is approved by the Federal Drug Administration (FDA) for the treatment of patients with advanced forms of myelofibrosis. It inhibits the Jak proteins that are often abnormal in MPN. A recent clinical study showed that ruxolitinib treatment could put some patients with your disease into remission. Decitabine is a chemotherapy, approved by the Federal Drug Administration (FDA) that has been used to treat acute leukemia. It works in some patients, but most patients with accelerated and blastic MPN do not respond to treatment. Ruxolitinib and decitabine will be combined in this study to find out what doses of the two medicines are safe together. Using Ruxolitinib in combination with Decitabine is experimental. We want to find out what effects, good and/or bad it has on you and your disease.
At the beginning of the study low dose of ruxolitinib will be used. If no bad side effects observed, the next 3 patients will receive a higher dose. Dose increases will continue until the most tolerable dose of ruxolitinib in combination with a fixed dose of decitabine is determined.