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A Sequential Two-Stage Dose Escalation Study to Evaluate the Safety and Efficacy of Ruxolitinib for the treatment of Chronic Myelomonocytic Leukemia (CMML): A Phase 2 Expansion
This study is to find out if treating Chronic Myelomonocytic Leukemia (CMML) with a study drug (ruxolitinib) can improve outcomes of patients with CMML.
Primary Objectives: 1.To determine overall best response rates as measured by the international working group MDS/MPN criteria. UUSecondary Objectives: 1.To determine the time to AML transformation of patients on Ruxolitinib. 2.To determine the median overall survival. 3.To determine the duration of response. 4.To determine the change in symptom score from baseline to week 16. 5.To determine the change in spleen volume at 16 weeks. 6.To determine if a correlation exist between the presence of the known recurrent mutations (JAK2, c-CBL, N-RAS, K-RAS, RUNX-1, TET2, SRSF2, EZH2, ASXL1, and DNMT3a) and response to ruxolitinib. 7.To determine if a correlation exists between inflammatory cytokine secretion in the peripheral blood and response to ruxolitinib in CMML patients.
Jakafi (Ruxolitinib); Ruxolitinib ()