Ibrutinib in Treating Participants with Early Stage Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Inclusion Criteria

• Diagnosis of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) that meets International Workshop on Chronic Lymphocytic Leukemia (IWCLL) diagnostic criteria.
• Patients must be aged over 18 years at the time of informed consent, understand and voluntarily sign an informed consent, and be able to comply with study procedures and follow-up examinations.
• No treatment indication according to IWCLL criteria.
• Estimated time to first treatment of 3 years or less according to MD Anderson Cancer Center (MDACC) nomogram.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Male and female subjects who agree to use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices [IUDs], complete abstinence, or sterilized partner) and a barrier method (eg., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug for females and 90 days for males. OR Female subjects who are of non-reproductive potential (ie, post-menopausal by history - no menses for >=1 year; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) except for patients with bilirubin elevation due to Gilbert's disease or of non-hepatic origin who will be allowed to participate.
• Alanine aminotransferase (ALT) =< 2.5 x ULN; and estimated creatinine clearance (CrCl) of > 30 mL/min, as calculated by the Cockcroft-Gault equation.
• Prothrombin time (PT)/international normalized ratio (INR) < 1.5 x ULN and partial thromboplastin time (PTT) (activated [a]PTT) < 1.5 x ULN (unless abnormalities are unrelated to coagulopathy or bleeding disorder).
• Free of prior malignancies for 3 years with exception of patients diagnosed with basal cell or non-metastatic squamous cell carcinoma of the skin, or carcinoma “in situ” of the cervix or breast, who are eligible even if they are currently treated or were treated and/or diagnosed in the past 3 years prior to study enrollment.
• A negative urine pregnancy test (within 7 days of enrollment date) is required for women with childbearing potential. Women of childbearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal (>= 1 year of no menses, by history)

Exclusion Criteria

• Receipt of any prior therapy for CLL. Patients who have received “early intervention” with INVAC-1 vaccine against hTERT will be eligible provided all of the following exist: i) They had no response to the vaccine treatment (persistent CLL > 1% in bone marrow). ii) ·3 months have elapsed since the last dose of vaccine. iii) No residual toxicities attributable to the vaccine exist at the time of study enrollment. iv) The patient does not meet IWCLL criteria for requiring treatment.
• Richter transformation.
• Active malignancy requiring systemic therapy, other than CLL, with the exception of: adequately treated in situ carcinoma of the cervix uteri; adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin; previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
• Systemic anticoagulation with warfarin or other Vitamin K antagonists.
• Active and uncontrolled autoimmune hemolytic anemia (AIHA) or autoimmune thrombocytopenia (ITP) requiring daily prednisone dose of >= 20 mg.
• Current and concurrent use of strong CYP3A4 inhibitors or inducers.
• Pregnant or breast-feeding females.
• Uncontrolled and active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment).
• Any other severe concurrent disease, or history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that, in the investigator’s opinion, may place the patient at undue risk to undergo therapy with ibrutinib.
• Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months prior to randomization.
• History of ischemic stroke within 6 months prior to enrollment.
• Evidence of bleeding diathesis or coagulopathy within 3 months (eg, von Willebrand’s disease or hemophilia.
• Any history of symptomatic intracranial hemorrhage.
• Major surgical procedure with 4 weeks of first dose of study drug; open biopsy, or significant traumatic injury within 7 days prior to enrollment date; anticipation of need for major surgical procedure during the course of the study.
• Minor surgical procedures, fine needle aspirations or core biopsies within 3 days prior to enrollment date. Bone marrow aspiration and/or biopsy are allowed.
• Serious, non-healing wound, ulcer, or bone fracture.
• Vaccinated with live, attenuated vaccines within 4 weeks of first dose of study drug.
• Active, uncontrolled infection.
• Known history of human immunodeficiency virus (HIV) or active with hepatitis C virus (HCV) or hepatitis B virus (HBV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
• Currently active, clinically significant hepatic impairment Child-Pugh class B or C according to the Child Pugh classification.