Ruxolitinib for Adult T-Cell Leukemia

• INCLUSION CRITERIA:
• Patients greater than or equal to 18 years old with pathologically confirmed smoldering or chronic adult T- cell leukemia as defined by Shimoyama.
• Patients must have serum antibodies directed to HTLV-1.
• Patients must have measurable or evaluable disease. Patients with > 10% of the PBMCs having the characteristic abnormal (i.e., CD3dim, CD4 plus CD25 plus expressing) FACS profile for circulating ATL cells will be considered to have evaluable disease.
• Patients must have adequate physiologic parameters:
• Absolute granulocyte count greater than or equal to 1000 K/microL, platelet count greater than or equal to 75,000 K/microL and hemoglobin greater than or equal to 10 g/dL.
• Bilirubin and creatinine less than or equal to 1.5 times institutional ULN.
• AST, ALT less than or equal to 3.0 times institutional ULN.
• Karnofsky Performance Score greater than or equal to 70% or ECOG less than or equal 1.
• Patients must be able to understand and sign Informed Consent Form.

EXCLUSION CRITERIA:

• Patients previously treated with a JAK inhibitor.
• Patients with symptomatic leukemic meningitis, bony or GI tract involvement, serum calcium or LDH > 1.5 times the upper limit of normal will be excluded. However, patients that have both ATL and another HTLV-1 associated disease such as tropical spastic paraparesis (HAM/TSP) will be included.
• Patients who have received high doses of systemic corticosteroids for the treatment of their ATL within 4 weeks prior to the start of therapy.
• Patients who have received any cytotoxic therapy, immunotherapy, antitumor vaccines or monoclonal antibodies in the 4 weeks prior to the start of the study.
• Life expectancy of less than 3 months.
• Documented HIV, active bacterial infections, active or chronic hepatitis B, hepatitis C or HTLV-II infection.
• A positive hepatitis B serology indicative of previous immunization (i.e., HBsAb positive and HBc Ab negative), or a fully resolved acute hepatitis B infection is not an exclusion criterion.
• A positive hepatitis C serology is an exclusion criterion.
• Pregnant and breast-feeding patients are not eligible for the study because the effects of ruxolitinib on the developing fetus are unknown.
• Inability or refusal to practice effective contraception during therapy. Men and women of childbearing potential must use an effective method of birth control or abstinence during treatment and for 4 months after completion of the treatment.
• Patient has significant and/or uncontrolled cardiac, renal, hepatic or other systemic disorders or significant psychological conditions at baseline visit that in the investigator's judgment would jeopardize subject enrollment or compliance with the study procedures.