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Lancet Haematology

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https://www.readbyqxmd.com/read/28733186/easix-in-patients-with-acute-graft-versus-host-disease-a-retrospective-cohort-analysis
#1
Thomas Luft, Axel Benner, Sonata Jodele, Christopher E Dandoy, Rainer Storb, Ted Gooley, Brenda M Sandmaier, Natalia Becker, Aleksandar Radujkovic, Peter Dreger, Olaf Penack
BACKGROUND: Endothelial dysfunction links thrombotic microangiopathy to steroid-refractory graft-versus-host disease (GVHD) after allogeneic stem-cell transplantation. We aimed to assess if the simple formula-lactate dehydrogenase (U/L) × creatinine (mg/dL)/thrombocytes (10(9) cells per L)-termed the Endothelial Activation and Stress Index (EASIX), might be valuable for the prediction of death in patients with acute GVHD after allogeneic stem-cell transplantation. METHODS: For this retrospective analysis, we analysed a training cohort (in Germany) and three validation cohorts (in Germany and the USA) of patients with acute GVHD who had received consecutive allogeneic stem-cell transplantation...
July 18, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28712941/rituximab-biosimilar-and-reference-rituximab-in-patients-with-previously-untreated-advanced-follicular-lymphoma-assist-fl-primary-results-from-a-confirmatory-phase-3-double-blind-randomised-controlled-study
#2
Wojciech Jurczak, Ilídia Moreira, Govind Babu Kanakasetty, Eduardo Munhoz, Maria Asunción Echeveste, Pratyush Giri, Nelson Castro, Juliana Pereira, Luiza Akria, Sergey Alexeev, Eugeniy Osmanov, Peijuan Zhu, Siyka Alexandrova, Angela Zubel, Olof Harlin, Jutta Amersdorffer
BACKGROUND: GP2013 is a rituximab biosimilar developed to stringent development guidelines, including non-clinical and preclinical investigations and clinical trials in rheumatoid arthritis and follicular lymphoma. We aimed to compare the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of GP2013 plus cyclophosphamide, vincristine, and prednisone (GP2013-CVP) with rituximab-CVP (R-CVP) in patients with follicular lymphoma. METHODS: In this phase 3, multinational, double-blind, randomised, controlled trial, adults (aged 18 years or older) with previously untreated, advanced stage (Ann Arbor stage III or IV) follicular lymphoma of WHO histological grades 1, 2, or 3a were randomly assigned (1:1) using interactive response technology to eight cycles of GP2013-CVP or R-CVP (combination phase), followed by monotherapy maintenance in responders for a 2-year period...
July 13, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28712940/efficacy-pharmacokinetics-and-safety-of-the-biosimilar-ct-p10-compared-with-rituximab-in-patients-with-previously-untreated-advanced-stage-follicular-lymphoma-a-randomised-double-blind-parallel-group-non-inferiority-phase-3-trial
#3
Won Seog Kim, Christian Buske, Michinori Ogura, Wojciech Jurczak, Juan-Manuel Sancho, Edvard Zhavrid, Jin Seok Kim, José-Ángel Hernández-Rivas, Aliaksandr Prokharau, Mariana Vasilica, Rajinish Nagarkar, Dzhelil Osmanov, Larry W Kwak, Sang Joon Lee, Sung Young Lee, Yun Ju Bae, Bertrand Coiffier
BACKGROUND: Studies in patients with rheumatoid arthritis have shown that the rituximab biosimilar CT-P10 (Celltrion, Incheon, South Korea) has equivalent efficacy and pharmacokinetics to rituximab. In this phase 3 study, we aimed to assess the non-inferior efficacy and pharmacokinetic equivalence of CT-P10 compared with rituximab, when used in combination with cyclophosphamide, vincristine, and prednisone (CVP) in patients with newly diagnosed advanced-stage follicular lymphoma. METHODS: In this ongoing, randomised, double-blind, parallel-group, active-controlled study, patients aged 18 years or older with Ann Arbor stage III-IV follicular lymphoma were assigned 1:1 to CVP plus intravenous infusions of 375 mg/m(2) CT-P10 or rituximab on day 1 of eight 21-day cycles...
July 13, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28712939/rituximab-biosimilars-introduction-into-clinical-practice
#4
Shinichi Makita, Kensei Tobinai
No abstract text is available yet for this article.
July 13, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28693986/do-we-perform-better-when-we-increase-red-blood-cells
#5
Stephane Perrey
No abstract text is available yet for this article.
July 7, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28687420/hepatic-adverse-event-profile-of-inotuzumab-ozogamicin-in-adult-patients-with-relapsed-or-refractory-acute-lymphoblastic-leukaemia-results-from-the-open-label-randomised-phase-3-ino-vate-study
#6
Hagop M Kantarjian, Daniel J DeAngelo, Anjali S Advani, Matthias Stelljes, Partow Kebriaei, Ryan D Cassaday, Akil A Merchant, Naohito Fujishima, Toshiki Uchida, Maria Calbacho, Anna A Ejduk, Susan M O'Brien, Elias J Jabbour, Hui Zhang, Barbara J Sleight, Erik R Vandendries, David I Marks
BACKGROUND: The INO-VATE study demonstrated efficacy and safety of inotuzumab ozogamicin versus standard care in adults with relapsed or refractory B-cell acute lymphoblastic leukaemia. Here, we report the frequency of, and potential risk factors for, hepatotoxicity in patients in this trial and after treatment and subsequent haemopoietic stem-cell transplantation (HSCT). METHODS: In this open-label, phase 3, multicentre, international study, adults with relapsed or refractory, CD22-positive, Philadelphia chromosome (Ph)-positive or Ph-negative B-cell acute lymphoblastic leukaemia who were due to receive first or second salvage treatment were randomly assigned (1:1) via an interactive voice response system to receive inotuzumab ozogamicin (starting dose 1·8 mg/m(2) per cycle [0·8 mg/m(2) on day 1; 0·5 mg/m(2) on days 8 and 15 of a 21-28 day cycle for ≤6 cycles]) or standard care (either fludarabine plus cytarabine plus granulocyte colony-stimulating factor, mitoxantrone plus cytarabine, or high-dose cytarabine)...
July 4, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28687419/selective-liver-toxicity-and-therapeutic-progress-in-acute-lymphoblastic-leukaemia
#7
Renato Bassan
No abstract text is available yet for this article.
July 4, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28669689/effects-of-erythropoietin-on-cycling-performance-of-well-trained-cyclists-a-double-blind-randomised-placebo-controlled-trial
#8
Jules A A C Heuberger, Joris I Rotmans, Pim Gal, Frederik E Stuurman, Juliëtte van 't Westende, Titiaan E Post, Johannes M A Daniels, Matthijs Moerland, Peter L J van Veldhoven, Marieke L de Kam, Herman Ram, Olivier de Hon, Jelle J Posthuma, Jacobus Burggraaf, Adam F Cohen
BACKGROUND: Substances that potentially enhance performance (eg, recombinant human erythropoietin [rHuEPO]) are considered doping and are therefore forbidden in sports; however, the scientific evidence behind doping is frequently weak. We aimed to determine the effects of rHuEPO treatment in well trained cyclists on maximal, submaximal, and race performance and on safety, and to present a model clinical study for doping research on other substances. METHODS: We did this double-blind, randomised, placebo-controlled trial at the Centre for Human Drug Research in Leiden (Netherlands)...
June 29, 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28668191/monoclonal-b-cell-lymphocytosis-in-a-hospital-based-uk-population-and-a-rural-ugandan-population-a-cross-sectional-study
#9
Andy C Rawstron, Aloysius Ssemaganda, Ruth de Tute, Chi Doughty, Darren Newton, Anna Vardi, Paul A S Evans, Kostas Stamatopoulos, Roger G Owen, Tracy Lightfoot, Katie Wakeham, Alex Karabarinde, Gershim Asiki, Robert Newton
BACKGROUND: Reported incidence of B-cell malignancies shows substantial geographical variation, being more common in the Americas and Europe than in Africa. This variation might reflect differences in diagnostic capability, inherited susceptibility, and infectious exposures. Monoclonal B-cell lymphocytosis (MBL) is a precursor lesion that can be screened for in apparently healthy people, allowing comparison of prevalence across different populations independently of health-care provision...
July 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28668190/do-big-numbers-assure-high-quality-of-data
#10
LETTER
Emanuele Crocetti, Carlotta Buzzoni
No abstract text is available yet for this article.
July 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28668189/unrelated-cord-blood-transplantation-for-non-malignant-diseases-every-hla-allele-counts
#11
Andromachi Scaradavou
No abstract text is available yet for this article.
July 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28668188/the-need-for-better-legislation-for-generic-drug-manufacturers
#12
EDITORIAL
The Lancet Haematology
No abstract text is available yet for this article.
July 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28623181/allele-level-hla-matching-for-umbilical-cord-blood-transplantation-for-non-malignant-diseases-in-children-a-retrospective-analysis
#13
Mary Eapen, Tao Wang, Paul A Veys, Jaap J Boelens, Andrew St Martin, Stephen Spellman, Carmem Sales Bonfim, Colleen Brady, Andrew J Cant, Jean-Hugues Dalle, Stella M Davies, John Freeman, Katherine C Hsu, Katharina Fleischhauer, Chantal Kenzey, Joanne Kurtzberg, Gerard Michel, Paul J Orchard, Annalisa Paviglianiti, Vanderson Rocha, Michael R Veneris, Fernanda Volt, Robert Wynn, Stephanie J Lee, Mary M Horowitz, Eliane Gluckman, Annalisa Ruggeri
BACKGROUND: The standard for selecting unrelated umbilical cord blood units for transplantation for non-malignant diseases relies on antigen-level (lower resolution) HLA typing for HLA-A and HLA-B, and allele-level for HLA-DRB1. We aimed to study the effects of allele-level matching at a higher resolution-HLA-A, HLA-B, HLA-C, and HLA-DRB1, which is the standard used for adult unrelated volunteer donor transplantation for non-malignant diseases-for umbilical cord blood transplantation...
July 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28602585/janus-kinase-2-inhibitor-fedratinib-in-patients-with-myelofibrosis-previously-treated-with-ruxolitinib-jakarta-2-a-single-arm-open-label-non-randomised-phase-2-multicentre-study
#14
Claire N Harrison, Nicolaas Schaap, Alessandro M Vannucchi, Jean-Jacques Kiladjian, Ramon V Tiu, Pierre Zachee, Eric Jourdan, Elliott Winton, Richard T Silver, Harry C Schouten, Francesco Passamonti, Sonja Zweegman, Moshe Talpaz, Joanne Lager, Zhenming Shun, Ruben A Mesa
BACKGROUND: Myelofibrosis is a chronic myeloproliferative neoplasm characterised by splenomegaly, cytopenias, bone marrow fibrosis, and debilitating symptoms including fatigue, weight loss, and bone pain. Mutations in Janus kinase-2 (JAK2) occur in approximately 50% of patients. The only approved JAK2 inhibitor for myelofibrosis is the dual JAK1 and JAK2 inhibitor, ruxolitinib. 58-71% of patients treated with ruxolitinib in clinical trials so far have not achieved the primary endpoint of 35% or more reduction in spleen volume from baseline assessed by MRI or CT...
July 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28602584/how-to-define-treatment-failure-for-jak-inhibitors
#15
Hans Michael Kvasnicka
No abstract text is available yet for this article.
July 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28566210/the-destiny-of-chronic-myeloid-leukeamia
#16
Elisabetta Abruzzese
No abstract text is available yet for this article.
July 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28566209/de-escalation-of-tyrosine-kinase-inhibitor-dose-in-patients-with-chronic-myeloid-leukaemia-with-stable-major-molecular-response-destiny-an-interim-analysis-of-a-non-randomised-phase-2-trial
#17
Richard E Clark, Fotios Polydoros, Jane F Apperley, Dragana Milojkovic, Christopher Pocock, Graeme Smith, Jenny L Byrne, Hugues de Lavallade, Stephen G O'Brien, Tony Coffey, Letizia Foroni, Mhairi Copland
BACKGROUND: Discontinuation of tyrosine kinase inhibitor (TKI) therapy is feasible for some patients with chronic myeloid leukaemia with deep molecular responses; however, patients with stable major molecular response (MMR), but not MR4, have not been studied, nor has the effect of treatment de-escalation rather than outright cessation. We aimed to examine the effects of treatment de-escalation as a prelude to complete cessation, not only in patients with MR4 or greater, but also in those with MMR but not MR4...
July 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28583289/long-term-outcomes-after-standard-graft-versus-host-disease-prophylaxis-with-or-without-anti-human-t-lymphocyte-immunoglobulin-in-haemopoietic-cell-transplantation-from-matched-unrelated-donors-final-results-of-a-randomised-controlled-trial
#18
Jürgen Finke, Claudia Schmoor, Wolfgang Andreas Bethge, Hellmut Ottinger, Matthias Stelljes, Liisa Volin, Dominik Heim, Hartmut Bertz, Olga Grishina, Gerard Socie
BACKGROUND: Previously, we demonstrated that the addition of anti-human-T-lymphocyte immunoglobulin (ATLG) to standard ciclosporin and methotrexate prophylaxis reduced graft-versus-host disease (GvHD) in adult patients treated with allogeneic haemopoietic cell transplantation from matched unrelated donors without negatively affecting relapse and survival. Since reports on long-term results from randomised trials testing anti-thymocyte globulin are scarce, we performed an extended follow-up of the trial...
June 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28583288/correction-to-lancet-haematol-2017-4-e165-75
#19
(no author information available yet)
No abstract text is available yet for this article.
June 2017: Lancet Haematology
https://www.readbyqxmd.com/read/28583287/correction-to-lancet-haematol-2017-4-e258-71
#20
(no author information available yet)
No abstract text is available yet for this article.
June 2017: Lancet Haematology
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