This study is to find out if treating Chronic Myelomonocytic Leukemia (CMML) with a study drug (ruxolitinib) can improve outcomes of patients with CMML.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Ruxolitinib 5 mg tablets, 4 per dose
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Weill Medical College of Cornell University
New York, New York, United States
Overall Response
Number of participants achieving clinical benefit defined as hematologic improvement, complete remission, partial remission, or stable disease by the International Working Group Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) Criteria.
Time frame: At week 16
Time to Acute Myeloid Leukemia (AML) Transformation
Time to AML transformation according to World Health Organization (WHO) Critieria
Time frame: Every 6 months after conclusion of treatment until end of study (40.3 months)
Overall Survival
Overall survival will be from first dose of study drug until failure or death from any cause.
Time frame: Up to 2 years
Duration of Response
Duration of response measured using time to AML transformation according to WHO Critieria
Time frame: Up to 2 years
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Cleveland Clinic
Cleveland, Ohio, United States