Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- Chronic Lymphocytic Leukemia
- Fatigue
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: 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 recommendat...
PRIMARY OBJECTIVES: 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 OBJECTIVES: 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.
Tracking Information
- NCT #
- NCT02131584
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Zeev Estrov M.D. Anderson Cancer Center
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