A Phase I/II, open-label, multi-center study evaluating the safety and efficacy of Ruxolitinib and CPX-351 in combination for the treatment of Secondary Acute Myeloid Leukemia Transformed from Myeloproliferative Neoplasms.
Patients with myeloproliferative neoplasms (MPNs) that undergo transformation to acute myelogenous leukemia (AML) have poor clinical outcomes. The safety and efficacy of the liposomal formulation of cytarabine and daunorubicin (CPX-351) will be assessed in combination with ruxolitinib to treat patients with post-MPN AML. The study will also look at the following:
• maximum tolerated dose (MTD) of ruxolitinib in combination with CPX-351best objective response rate during the first 2 cycles of treatment
• bone marrow cellularity
• instances of adverse events
• twelve month overall survival
• twelve month progression-free survival
• treatment-related toxicity
Secondary Acute Myeloid Leukemia Transformed from Myeloproliferative Neoplasms
Patients diagnosed with post-MPN AML.
18 - 100
Healthy Volunteers Needed
Duration of Participation
Treatment period is anticipated to be ~12 months with 1 year of follow-up.
Incyte and Jazz Pharmaceuticals