A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib
Status:
Active, not recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to find out if treating Chronic Myelomonocytic Leukemia (CMML)
with a study drug [ruxolitinib] can improve outcomes of patients with CMML. The first step of
the study is to learn the dose of ruxolitinib that is tolerable (bearable). It has already
been studied in a number of patients with different bone marrow diseases and is approved for
the treatment of a disease called Myelofibrosis; however, it is not approved for treatment of
CMML. It is given orally (by mouth). Most people tolerate it well but the tolerability has
not been determined in patients with CMML. We will be testing different doses to determine
how much of the medication people can tolerate (bear) before they develop side effects.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute