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Lymphoid Hyperplasia

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161. Recurrent Hodgkin Lymphoma

for patients receiving total lymphoid irradiation and autologous blood stem-cell transplantation for relapsed and refractory Hodgkin lymphoma. Br J Haematol. 2014;165(6):793-800. 33. Brice P, Divine M, Simon D, et al. Feasibility of tandem autologous stem-cell transplantation (ASCT) in induction failure or very unfavorable (UF) relapse from Hodgkin's disease (HD). SFGM/GELA Study Group. Ann Oncol. 1999;10(12):1485-1488. ACR Appropriateness Criteria ® 7 Recurrent Hodgkin Lymphoma 34. Herbst C, Rehan FA (...) Pathologic confirmation should help differentiate between relapse, follicular hyperplasia, infection, and transformation. Recommended Treatment RT alone 2 Salvage chemotherapy alone 3 Salvage chemotherapy + RT 3 Salvage chemotherapy + SCT 7 Salvage chemotherapy + RT + SCT (CR to salvage chemotherapy) 8 Volume of RT (After CR to Chemotherapy) RT (ISRT) to site of relapse 8 Adjuvant RT to recurrent and all previously untreated nodal sites (TLI) 4 Timing of RT Primary therapy 2 Following salvage

2016 American College of Radiology

162. Celiac Disease

, this excess rate of major complications appears to resolve after 3– 5 years on a strictly gluten-free diet. The risk for asymptomatic celiac disease cases that are only detected on serological screening is poorly known. Key diagnostic findings include: ? Characteristic histopathologic changes in intestinal mucosal biopsies, including intraepithelial lymphocytosis, crypt hyperplasia, and various grades of villous atrophy. ? Evidence that small-intestinal enteropathy is dependent on gluten, which can (...) for the development of celiac disease ( 25/100 epithelial cells) ? Crypt hyperplasia, with a decreased villi/crypt ratio ? Blunted or atrophic villi ? Mononuclear cell infiltration into the lamina propria ? Epithelial changes, including structural abnormalities in epithelial cells It is highly recommended that the pathologist ’s report should include changes in a structured format, including the above-mentioned histological changes, intraepithelial lymphocyte count, and interpretation in terms of the modified

2016 World Gastroenterology Organisation

164. Cometriq - cabozantinib

500 mg/kg =1000: death, weight?, ALT?, AST?, CK?, GGT?, LDH? XL184-NC-003 GLP Rat M+F/5 100, 300, 900 mg/kg Oral gavage 100 mg/kg =100: ALT, AST, ALP, cholesterol, total bilirubin? =300: death, histopathologic changes in adrenal gland, lung 900: prostration, coldness to touch, abnormal respiration; clinical pathology changes indicative of liver and hematopoietic toxicity, dehydration; histopathologic changes in GI tract, lymphoid tissues, bone marrow, adrenal gland, lung, testes, kidney, pancreas (...) XL184-NC-001 Dose range- finding Non-GLP Dog M/2 30, 60, 120, 240, 480 mg/kg Oral gavage >480 mg/kg =120: hypoactivity (F) =240: Ca, PO4? 480: WBC, neutrophil, and monocyte counts, cholesterol, ALT, AST? XL184-NC-004 GLP Dog M+F/2 400, 1000, 2000 mg/kg Oral gavage >2000 mg/kg 2000: excessive salivation Repeat dose toxicity In rats the most important target tissues for cabozantinib-related toxicity after 2 weeks of oral gavage are GI tract, bone marrow, lymphoid tissues, reproductive tract tissues

2014 European Medicines Agency - EPARs

165. Tecfidera - dimethyl fumarate

, elevated glutathione and ATP levels and resistance against H 2 O 2 treatment. In vivo, DMF induced NQO1 in lymphoid organs and Akr1b8 in gastrointestinal tissues in wild type mice and rats for up to 24 h. The dependency of oxidative protection on Nrf2 was confirmed in vitro by silencing of Nrf2 transcription with specific siRNA and in vivo by the lack of a pharmacodynamic response in Nrf2 - / - mice. DMF also significantly diminished excitotoxic lesion volume (44 and 61 %, at DMF doses of 75 and 100 mg (...) as main target organs for toxicity in animals. Nephrotoxicity was detected in four different animal species and included renal tubule epithelial regeneration suggestive of injury. Such toxicity was also associated with renal tubular adenomas and carcinomas in mice and rats (see below). Increased liver weights were detected in mice, rats and dogs. Minimal multifocal hepatic necrosis and bile duct hyperplasia were also noted in rats. Given that no safety margins towards intended therapeutic levels

2014 European Medicines Agency - EPARs

166. Sylvant - siltuximab

characterized by growth of lymphoid tissue (Bowne 1999). This syndrome is known by a variety of names, including giant lymph node hyperplasia, angiofollicular lymph node hyperplasia, angiomatous lymphoid hamartoma, lymph nodal haematoma, and lymph node hyperplasia of Castleman (Greiner 2000). CHMP assessment report EMA/CHMP/258608/2014 Page 9/92 Clinically, patients present with lymph node growth that is confined to a single location (unicentric Castleman’s disease) or occurs in multiple locations (MCD

2014 European Medicines Agency - EPARs

167. Zydelig - idelalisib

Investigational New Drug (Application) iNHL indolent non-Hodgkin lymphoma IRC independent review committee ITT intent-to-treat KM Kaplan-Meier LDH lactate dehydrogenase LPL lymphoplasmacytic lymphoma m module mAb monoclonal antibody MALT mucosa-associated lymphoid tissue MCL mantle cell lymphoma MedDRA Medical Dictionary for Regulatory Activities MID minimally important difference MM multiple myeloma MR minor response MRI magnetic resonance imaging MST medical search term MZL marginal zone lymphoma N or n (...) this approach is limited especially with respect to MZL and LPL/WM. In resistant and refractory stages the current treatment alternatives are very limited and often carry significant toxicities. About the product Idelalisib inhibits phosphatidylinositol 3 kinase p110d (PI3Kd), which is hyperactive in B cell malignancies and is central to multiple signalling pathways that drive proliferation, survival, homing, and retention of malignant cells in lymphoid tissues and bone marrow. Idelalisib is a selective

2014 European Medicines Agency - EPARs

169. Mekinist - trametin

, GI damage, lymphoid organ depletion, bone marrow cellularity ?, labored breathing, killed in moribund condition, F: red blood cell parameters ? bw=body weight; M=male; F=female; GI=gastrointestinal; Hb=haemoglobin; WBC=white blood cells; P=serum inorganic phosphorus; ALP=alkaline phosphatase CHMP assessment report EMA/CHMP/675236/2013 Page 26/132 Repeat dose toxicity Table 2: Repeat-dose toxicity studies with trametinib Study ID Species/Sex/ Number/Group Dose/Route mg/kg/day Duration NOEL/ NOAEL (...) showed that trametinib was a skin sensitiser. Regarding the immunotoxicity of trametinib, in the repeated dose toxicity studies done on rats with a daily oral dosing for up to 13 weeks, it was shown that the principal immune-related adverse effect was bone marrow degeneration/necrosis and lymphoid necrosis in lymph nodes, spleen and thymus. In addition, adverse skin and gastric changes were associated with inflammation, characterized by increased cellularity (lymphocytes and plasma cells) in lymph

2014 European Medicines Agency - EPARs

172. Entyvio - vedolizumab

-linked immunosorbent assay ET early Termination FP Finished Product GALT gut-associated lymphoid tissue GI gastrointestinal GLP good laboratory practice GPI generic product identifier HAHA human anti-human antibodies HBI Harvey Bradshaw Index HBV hepatitis B virus Entyvio Assessment report EMA/CHMP/676643/2013 Page 5/166 HCV hepatitis C virus HIV human immunodeficiency virus HLT high level term HPLC High Performance Liquid Chromatography HRQOL health-related quality of life HRP horseradish Peroxidase (...) -02 and MLN02 MS multiple sclerosis N/A not applicable NC negative Control NEC not elsewhere classified ND not determined nHAHA neutralising HAHA NHP non-human primate NK natural killer NMSC Non-Melanoma Skin Cancer NOAEL no observed adverse effect level NOR Normal Operating Ranges NSAID nonsteroidal anti-inflammatory drug OD Optical Density PAHA primate antihuman antibodies Ph. Eur. European Pharmacopoeia PALS Periarteriolar lymphoid sheaths PASS Post Authorisation Safety Study PBMC Peripheral

2014 European Medicines Agency - EPARs

175. Antibody-Mediated Rejection in Cardiac Transplantation: Emerging Knowledge in Diagnosis and Management Full Text available with Trip Pro

of heart transplantation, the heart transplant community has typically taken its lead from experience in renal transplantation, adapting therapies that were originally designed to treat hematologic diseases, malignancies, and autoimmune disorders. , Broadly speaking, the underlying mechanisms for these therapies are based on the following: (1) Suppression of the T-cell response (eg, corticosteroids, mycophenolate mofetil (MMF), anti-lymphocyte antibodies, photopheresis, or total lymphoid irradiation

2015 American Heart Association

177. Primary Sclerosing Cholangitis

American Journal of GASTROENTEROLOGY www.amjgastro.com 656 VOLUME 110 | MAY 2015 Lindor et al. 18. G ra n t A J , G o dda r d S , Ahmed-Cho udh u r y J et al. H epa tic exp r essio n o f secondary lymphoid chemokine (CCL21) promotes the development of portal-associated lymphoid tissue in chronic infl ammatory liver disease . Am J P a t h o l 2002 ; 160 : 1445 – 55 . 19. P o l S , Ro ma na CA , Ric h a r d S et al. M icr osp o r idia inf ec tio n in pa tien ts with the human immunodefi ciency virus

2015 American College of Gastroenterology

178. Diagnosis and Management of Aplastic Anaemia

; sometimes hypocellularity is patchy with both hypocellular and residual cellular areas. Focal hyperplasia of erythroid or granulocytic cells at a similar stage of maturation may be observed. Small lymphoid aggregates may occur, particularly in the acute phase of the disease or when AA is associated with systemic autoimmune diseases, such as rheumatoid arthritis or systemic lupus erythematosus. Increased reticulin staining, dysplastic megakaryocytes (best assessed by immunohistochemistry) and blasts (...) with pancytopenia and a patchy hypocellular bone marrow with limited areas of lymphoid infiltration that can easily be missed in small samples. The bone marrow biopsy should be examined carefully for foci of lymphoma cells or fibrosis, which may be seen in only a small part of the specimen. Lymphocytes are often prominent in AA and immunophenotypic marker studies and gene rearrangement studies will help to exclude a diagnosis of lymphoma. Additional features, such as splenomegaly, make AA very unlikely Primary

2015 British Committee for Standards in Haematology

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