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Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Bu çalışma, nüks etmiş veya tedaviye dirençli diffüz büyük B hücreli lenfoma (diffuse large B-cell lymphoma) olan hastalarda kök hücre nakli öncesi ve sonrası Ibrutinib kullanımını incelemektedir. Çalışmada Ibrutinib, otolog kök hücre nakli ve yoğun kemoterapi ile birlikte, plasebo ile karşılaştırmalı olarak uygulanmaktadır. Faz 3 aşamasında yürütülmüş; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).
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Inclusion Criteria: * PRE-REGISTRATION ELIGIBILITY CRITERIA (STEP 0) * Patients must have paraffin tissue from the diagnostic or relapse biopsy available to be submitted for central pathology review; this review is mandatory prior to registration to confirm eligibility and should be initiated as soon as possible * ELIGIBILITY CRITERIA (STEP 1) * Diagnosis of World Health Organization (WHO) diffuse large B-cell lymphoma, non-GCB by central review confirmation * Patient must be deemed eligible to proceed with high-dose chemotherapy and autologous stem cell transplantation by local transplant center * New York Heart Association class I or less; ordinary physical activity does not cause undue fatigue, palpitations, dyspnea, or angina pain; patients 60 years or older must have a left ventricular ejection fraction (LVEF) at rest \>= 40% measured by echocardiogram or multi-gated acquisition (MUGA) * Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards) * Forced expiratory volume in 1 second (FEV1) \>= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards) * Forced vital capacity (FVC) \>= 40% of predicted (corrected or uncorrected for hemoglobin per institutional standards) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) unless isolated hyperbilirubinemia attributed to Gilbert's syndrome * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 x upper limit of normal (ULN) * Creatinine =\< 2.0 mg/dL OR creatinine clearance (calculated clearance permitted) \>= 40 mL/min by Cockcroft-Gault formula * Prothrombin time (PT)/ international normalized ration (INR) \< 1.5 x ULN and partial thromboplastin time (PTT) (activated \[a\]PTT) \< 1.5 x ULN * Patient must have progressed or be refractory to prior anthracycline-containing chemotherapy (e.g. rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone \[R-CHOP\], dose adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab \[DA-EPOCH-R\], etc) * No more than 3 prior regimens for large cell component (e.g. one induction and two salvage therapies); monoclonal antibody alone or involved field/involved site radiotherapy do not count as lines of therapy. Prior CART therapy is allowed and counts as one line of therapy * Prior use of ibrutinib is allowed unless patient has had disease progression while receiving ibrutinib * Patient must have chemosensitive disease as defined by at least a partial response to salvage therapy at their latest assessment * No major surgery =\< 7 days prior to registration and no minor surgery =\< 3 days prior to registration (with the exception of intravenous access placement, e.g. Hickman or peripherally inserted central catheter \[PICC\]) * Not pregnant and not nursing, because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative serum pregnancy test must be obtained within 14 days prior to registration * Women of childbearing potential must use adequate contraception from study start to one month after the last dose of protocol therapy; adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence; men must practice complete abstinence or agree to use an adequate contraception method from study start to one month after the last dose of protocol therapy * Age \>= 18 years * Patients should not require chronic use of strong CYP3A inhibitors or strong CYP3A inducers * Patients should not require concurrent therapeutic doses of steroids (\> 20 mg of prednisone/day or equivalent) unless they need them for the indications; steroids should be discontinued for 14 days before starting protocol treatment * Human immunodeficiency virus (HIV) infected patients are eligible provided they meet all other eligibility criteria, and: * There is no prior history of acquired immunodeficiency syndrome (AIDS) defining conditions other than historically low CD4+ T-cell count or B-cell lymphoma * In the opinion of an expert in HIV disease, prospects for long-term survival are excellent were it not for the diagnosis of lymphoma * Use of HIV protease inhibitors as part of the anti-HIV regimen OR as a pharmacologic booster is not allowed * Zidovudine is not allowed * Once daily combination pills for HIV containing a pharmacologic booster such as cobicistat are not allowed * Patients with multi-drug resistant HIV are not eligible * Patients cannot have: * Active central nervous system or meningeal involvement by lymphoma; patients with a history of central nervous system (CNS) or meningeal involvement must be in a documented remission by cerebrospinal fluid (CSF) evaluation and contrast-enhanced magnetic resonance imaging (MRI) imaging for at least 91 days prior to registration * Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy * A known bleeding diathesis * Requirement for warfarin or similar vitamin K antagonists; these drugs are prohibited 28 days prior to the first treatment and throughout the trial * History of stroke or intracranial hemorrhage =\< 6 months before treatment * Currently active, clinically significant hepatic impairment (Child-Pugh class B or C according to the Child Pugh classification * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ibrutinib or other agents used in study * Serologic status reflecting active hepatitis B or C infection; patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment; (PCR positive patients will be excluded) * Eastern Cooperative Oncology Group (ECOG) performance status must be =\< 2