This phase I/II trial studies the side effects and best dose of ruxolitinib when given together with decitabine and to see how well they work in treating patients with acute myeloid leukemia that has come back or is not responding to treatment, or has developed from a type of bone marrow disease called myeloproliferative neoplasms. Ruxolitinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ruxolitinib together with decitabine may be an effective treatment for acute myeloid leukemia.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02257138.
PRIMARY OBJECTIVES:
I. To determine the tolerability of the combination of decitabine and ruxolitinib (DI) in patients with leukemia. (Phase I)
II. To determine the efficacy of ruxolitinib in increasing and prolonging response induced by decitabine alone in patients with post myeloproliferative neoplasm acute myeloid leukemia (AML) (post MPN-AML) alternatively referred to as (myeloproliferative neoplasm - blast phase; MPN-BP). (Compared to historical response rate with decitabine alone) (Phase II)
SECONDARY OBJECTIVES:
I. To compare whether there is a difference in response rate patients with post-MPN AML with janus kinase 2 (JAK2) mutations and patients without JAK2 mutations.
OUTLINE: This is a phase I, dose-escalation study of ruxolitinib phosphate followed by a phase II study.
Patients receive ruxolitinib orally (PO) twice daily (BID) on days 1-28 and decitabine intravenously (IV) over 1-2 hours on days 1-5. Treatment repeats every 4-6 weeks for up to 24 cycles in the absence of disease progression or unacceptable toxicity.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorFarhad Ravandi-Kashani
