Ibrutinib With Rituximab and Lenalidomide for Patients With Recurrent/Refractory Primary or Secondary Central Nervous System Lymphoma (PCNSL/SCNSL)

Exclusion Criteria

• •Patients with SCNSL actively receiving treatment for extra-CNS disease are excluded.
• •Patient is concurrently using other approved or investigational antineoplastic agents.
• •Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C prior to starting the study drug, or the patient has not recovered from the side effects of such therapy.
• •Patient has received external beam radiation therapy to the CNS within 21 days of the first dose of the study drug.
• •Patient requires more than 8 mg of dexamethasone daily or the equivalent
• •Patient has an active concurrent malignancy requiring active therapy
• •The patient has been treated with radio- or toxin-immunoconjugates within 70 days of the first dose of the study drug.
• •Patient is allergic to components of the study drug.
• •Patient is using warfarin or any other Coumadin-derivative anticoagulant or vitamin K antagonists. Patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug. Low molecular weight heparin is allowed. Patients with congenital bleeding diathesis are excluded.
• •Patient is taking a drug known to be a moderate and strong inhibitor or inducers of the P450 isoenzyme CYP3A. Participants must be off P450/CYP3A inhibitors and inducers for at least two weeks prior to starting the study drug.
• •Patient is using systemic immunosuppressant therapy, including cyclosporine A, tacrolimus, sirolimus, and other such medications, or chronic administration of \> 5 mg/day or prednisone or the equivalent. Participants must be off immunosuppressant therapy for at least 28 days prior to the first dose of the study drug.
• •Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening,
• •Patient has a known bleeding diathesis (e.g. von Willebrand"s disease) or hemophilia.
• •Patient is known to have human immunodeficiency virus (HIV) infection.
• •Patient is known to have a history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) as determined by serologic tests.
• •Patient is known to have an uncontrolled active systemic infection.
• •Patient underwent major systemic surgery ≤ 4 weeks prior to starting the trial treatment or who has not recovered from the side effects of such surgery, or who plan to have surgery within 2 weeks of the first dose of the study drug.
• •Patient is unable to swallow capsules or has a disease or condition significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, or complete bowel obstruction.
• •Patient has poorly controlled diabetes mellitus with a glycosylated hemoglobin \>8% or poorly controlled steroid-induced diabetes mellitus with a glycosylated hemoglobin of \>8%. (for patients who received a short-term, high-dose dexamethasone treatment course prior to enrollment (\<7 days), the HbA1c value can be rounded to the nearest whole number).
• •Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject"s safety or put the study outcomes at undue risk.
• •Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive serum hCG laboratory test of \> 5 mIU/mL (See section on Pregnancy and Reproduction)
• •Patient has undergone prior allogenic stem cell transplant (autologous stem cell transplant is NOT an exclusion)
• •The patient is unwell or unable to participate in all required study evaluations and procedures
• •Known hypersensitivity to ibrutinib, thalidomide or lenalidomide
• •Females who are pregnant.