Itacitinib and Alemtuzumab in Treating Patients with T-Cell Prolymphocytic Leukemia

Inclusion Criteria

• Patients with a diagnosis of T-cell prolymphocytic leukemia (T-PLL) will be eligible (both treatment naive and relapsed patients are eligible).
• Patients must not have had chemotherapy or antibody therapy for 7 days prior to starting itacitinib. However, patients with rapidly proliferative disease may receive hydroxyurea or decadron until 24 hours prior to starting therapy on this protocol.
• Bilirubin =< 2 mg/dL.
• Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN) or =< 5 x ULN if related to leukemic involvement.
• Estimated creatinine clearance > 50.
• Known cardiac ejection fraction of > or = 45% within the past 3 months.
• Platelet count of >= 30,000.
• Eastern Cooperative Oncology Group (ECOG) performance status of =< 2.
• A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
• Patient must have the ability to understand the requirements of the study and signed informed consent. A signed informed consent by the patient or his legally authorized representative is required prior to their enrollment on the protocol.

Exclusion Criteria

• Pregnant women are excluded from this study because the agent used in this study has the potential for teratogenic or abortifacient effects. Because there is a potential risk for adverse events in nursing infants secondary to treatment of the mother with the chemotherapy agents, breastfeeding should also be avoided.
• Uncontrolled intercurrent illness including, but not limited to active uncontrolled infection, symptomatic congestive heart failure (New York Heart Association [NYHA] class III or IV), unstable angina pectoris, clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with recent ischemic or hemorrhagic stroke, history of autoimmune disease requiring systemic immunesuppressants, or active autoimmune cytopenias will be excluded.
• Patients with grade >= 2 peripheral neuropathy will be excluded.
• Patients taking strong CYP3A modulators (inhibitors or inducers) should not take these drugs for 72 hours prior to enrolling on this study (or prior to first dose of study drug).
• Patient with documented hypersensitivity to any of the components of the therapy program.
• Patients with known active, uncontrolled central nervous system (CNS) leukemia will not be eligible.
• Patients with prior treatment with a JAK1, JAK2, or JAK3 inhibitor will not be eligible.
• Men and women of childbearing potential who do not practice contraception. Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.
• Known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibodies).
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation. Hepatitis B virus deoxyribonucleic acid (DNA) and HCV ribonucleic acid (RNA) must be undetectable upon testing. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Prior test results obtained as part of standard of care that confirm a subject is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility and tests do not need to be repeated. Subjects with prior positive serology results must have negative polymerase chain reaction results. Subjects whose immune status is unknown or uncertain must have results confirming immune status before enrollment.