Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia

Inclusion Criteria:

• Subjects who are able to understand and sign an informed consent document

• Subjects must be diagnosed with CLL and do not meet the IWCLL criteria for treatment

• Patients may have been previously treated or previously untreated

• Symptomatic patients with a BFI symptom scale of 2 points or greater

• Subjects with hemoglobin values at the screening visit equal to or greater than 12.0g/dL

• Subjects with a platelet count of at least 75 x 10^9/L at the screening visit

• Subjects with an absolute neutrophil count (ANC) of equal to or higher than 0.5 x 10^9/L at the screening visit

• Subjects must have discontinued all drugs used to treat CLL no later than day -30

• Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2

Exclusion Criteria:

• Females who are pregnant or are currently breastfeeding

• Subjects of childbearing potential who are unwilling to take appropriate precautions (throughout the study from screening, including 30 days after discontinuation of thestudy drug) to avoid becoming pregnant or fathering a child

• Females of non-childbearing potential are defined as women who (a) are equal toor greater than 55 years of age with history of amenorrhea for 1 year, or (b)are surgically sterile for at least 3 months

• For females of childbearing potential, or for males, appropriate precautionsare those that are at least 99% effective in preventing the occurrence ofpregnancy; these methods should be communicated to the subjects and theirunderstanding confirmed:

• Complete abstinence from sexual intercourse

• Double barrier methods

• Condom with spermicide in conjunction with use of an intrauterine device (IUD)

• Condom with spermicide in conjunction with use of a diaphragm

• Oral, injectable, or implanted contraceptives

• Tubal ligation or vasectomy (surgical sterilization)

• Subjects with recent history of inadequate bone marrow reserve as demonstrated byprevious transfusions except for acute blood loss (e.g. surgery) in the month priorto screening

• Alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN)

• Modification of diet in renal disease (MDRD) calculated glomerular filtration rate (GFR) < 30 mL/min

• Subjects with active uncontrolled infection or who are human immunodeficiency virus (HIV) positive (subjects with acute infections requiring treatment should delayscreening/enrollment until the course of therapy has been completed and the event isconsidered controlled)

• Subjects with an invasive malignancy over the previous 2 years except treated basalor squamous carcinomas of the skin completely resected intraepithelial carcinoma ofthe cervix and completely resected papillary thyroid and follicular thyroid cancers;other completely resected cancers greater than 2 years may be considered afterreview by the principal investigator (PI)

• Subjects with clinically significant uncontrolled cardiac disease

• Subjects being treated concurrently with any prohibited medications, includinginvestigational medication, rifampin, St. John's wort, and potent cytochrome P450,family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors (excluding ketoconazole)unless continuation of such medications are determined by the investigator to be inthe best interest of the patient

• Subjects who have previously received JAK inhibitor therapy

• Subjects with active alcohol or drug addiction that would interfere with theirability to comply with the study requirements

• Subjects with any concurrent condition that, in the investigator's opinion, wouldjeopardize the safety of the subject or compliance with the protocol

• Subjects who have unknown transfusion history for at least the 12 weeks prior toscreening

• Subjects who are unable to complete the symptom diary

• Subjects who will need conventional therapy during the course of the study