Testing Methotrexate with Rituximab (where available) for non-hodgkin lymphoma

Exclusion

• −Patients with a known hypersensitivity to the study drugs or their components
• −Active, uncontrolled bacterial, fungal, or viral infection within 7 days prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →. Patients with hepatitis B serology suggestive of past infection (for example anti-HB-c positive but HBsAG and anti-HBs negative) are eligible if they are HBV DNA negative are being or will be concurrently treated with anti-viral therapy. Patients with a history of hepatitis C which has been treated and is no longer active are eligible. Patients with known human immunodeficiency virus (HIV) with CD4 count \< 350 cells/microliter are ineligible. Patients who are HIV positive are eligible, provided:
• −HIV viral load must be \< 400 copies/ml within 16 weeks prior to enrollment AND No history of opportunistic infections within the past year
• −Patients with secondary central nervous system non-Hodgkin lymphoma (NHL).
• −Patients with significant third space accumulation (pleural effusions, ascites) which cannot be adequately drained in advance of methotrexate administration
• −Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. However, patients on active anticancer therapy for other advanced or metastatic malignancies are not eligible.
• −They have received antiretroviral therapy for at least 4 weeks prior to enrollment, and the anti-viral drugs used are not known to have clinically relevant drug-drug interactions with ibrutinib AND
• −Serious illnesses or medical conditions which would not permit the patient to be managed according to protocolProtocolThe detailed plan a study must follow.Read more →
• −Patients may not receive concurrent treatment with other anti-cancer therapy or investigational agents while on protocol therapy
• −Patients with prior allogenic bone marrow transplant or double umbilical cord blood transplantation.
• −Patients requiring:
• −Anticoagulation with warfarin or equivalent vitamin K antagonists
• −Continued requirement for therapy with a strong CYP3A inhibitor or inducer (see trial webpage for list)
• −Corticosteroid treatment with \> 8mg of dexamethasone (or equivalent) at the time of enrollment
• −Supplements containing fish oil or vitamin E, and grapefruit juice should be avoided
• −Live attenuated vaccination administered within 30 days prior to enrollment
• −Patients with clinically significant cardiac disease, including:
• −angina pectoris, symptomatic pericarditis, coronary artery bypass grafting, coronary angioplasty, or stenting, or myocardial infarction in the previous 12 months;
• −history of documented congestive heart failure (New York Heart Association functional classification III-IV) or cardiomyopathy;
• −uncontrolled hypertension (per Canadian guidelines);
• −atrial or ventricular arrhythmias; patients with controlled atrial fibrillation are eligible
• −Patients with distant clinically significant cardiac history should have a LVEF ≥ 50% BaselineBaselineYour starting measurements, taken before treatment begins.Read more → LVEF is not required for patients with only a cardiac history of hypertension which is now controlled.
• −Patients may not receive concurrent treatment with other anti-cancer therapy or investigational agents while on protocol therapy.
• −Patients with prior allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT).
• −Patients requiring:
• −Anticoagulation with warfarin or equivalent vitamin K antagonists
• −Continued requirement for therapy with a strong CYP3A inhibitor or inducer
• −Corticosteroid treatment with \> 8mg of dexamethasone (or equivalent) at the time of enrollment
• −Supplements containing fish oil or vitamin E, and grapefruit juice should be avoided.
• −Live attenuated vaccination administered within 30 days prior to enrollment, or within 30 days prior to start date of pre-study methotrexate +/- rituximab for participants who receive one cycle before enrollment.
• −Pregnant or breastfeeding women
• −Pregnant or breastfeeding women.