This phase II trial studies how well ruxolitinib phosphate works in reducing fatigue in patients with chronic lymphocytic leukemia. Ruxolitinib phosphate may stop the growth of cancer cells by blocking a protein called Janus kinase (JAK) that is needed for cell growth and may also help control fatigue, decrease the size of lymph nodes and/or lower the number of chronic lymphocytic leukemia cells in the blood.
PRIMARY OBJECTIVE: I. To estimate the reduction in fatigue as measured by the Brief Fatigue Inventory (BFI) of patients with chronic lymphocytic leukemia (CLL) who do not require anti-neoplastic therapy according to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 recommendations. SECONDARY OBJECTIVE: I. To estimate the reduction in other symptoms using the M. D. Anderson Symptom Inventory (MDASI) and to assess disease burden and response by the IWCLL 2008 response criteria. OUTLINE: Patients receive ruxolitinib phosphate orally (PO) twice daily (BID) (approximately 12 hours apart) for up to 2 years in the absence of disease progression or unacceptable toxicity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
10
Ancillary studies
Given PO
M D Anderson Cancer Center
Houston, Texas, United States
Change in fatigue
As measured by the Brief Fatigue Inventory (BFI) question 3 regarding the worst fatigue in the past 24 hours. Will be analyzed in a continuous fashion.
Time frame: Baseline to 3 months
Proportion of patients with 2 point reductions in the BFI #3 score
Proportion of patients at 3 months versus at enrollment tabulated.
Time frame: Up to 3 months
20% improvement in symptoms
As measured by the M. D. Anderson Symptom Inventory (MDASI).
Time frame: Up to 3 months
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