Spots Global Cancer Trial Database for Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia

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Trial Identification

Brief Title: Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia

Official Title: Administration of Jakafi (Ruxolitinib) for Symptom Control of Patients With Chronic Lymphocytic Leukemia (CLL): A Phase II Study

Study ID: NCT02131584

Conditions

Chronic Lymphocytic Leukemia

Interventions

Questionnaire Administration

Ruxolitinib Phosphate

Study Description

Brief Summary: 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.

Detailed Description: 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.