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Journal articles on the topic 'Co-speakers’ reactions'

Author: Grafiati

Published: 2 June 2025

Last updated: 31 July 2025

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1

Shima, Midori, Keiji Nogami, Sayaka Nagami, et al. "Every 2 Weeks or Every 4 Weeks Subcutaneous Injection of Emicizumab in Pediatric Patients with Severe Hemophilia A without Inhibitors: A Multi-Center, Open-Label Study in Japan (HOHOEMI Study)." Blood 132, Supplement 1 (2018): 1186. http://dx.doi.org/10.1182/blood-2018-99-115792.

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Abstract Introduction: Emicizumab is a novel, subcutaneously injectable, recombinant humanized bispecific monoclonal antibody which mimics the function of activated coagulation factor VIII. Due to its mechanism of action and lack of sequence homology, emicizumab is not expected to induce or be affected by anti-factor VIII (FVIII) antibodies (inhibitors). Emicizumab once-weekly dosing has been approved for hemophilia A patients with inhibitors of all ages in several countries. A clinically meaningful prophylactic effect and favorable safety of emicizumab given every 2 weeks (Q2W) and every 4 we

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Jacoby, Meagan A., Laura E. Finn, Ashkan Emadi, et al. "Post-Marketing Observational Study to Assess the Incidence of Infusion-Related Reactions in Adult Patients with Therapy-Related Acute Myeloid Leukemia (AML) or AML with Myelodysplasia-Related Changes Who Were Treated with CPX-351." Blood 136, Supplement 1 (2020): 19. http://dx.doi.org/10.1182/blood-2020-136880.

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Introduction: CPX-351 (Vyxeos®; daunorubicin and cytarabine liposome for injection), a dual-drug liposomal encapsulation of daunorubicin and cytarabine in a synergistic 1:5 molar ratio, has been approved by the US FDA and EMA for the treatment of adults with newly diagnosed, therapy-related AML or AML with myelodysplasia-related changes. The primary endpoint analysis of the pivotal phase 3 study (NCT01696084) that formed the basis for the approvals evaluated older patients with newly diagnosed high-risk/secondary AML; after a median follow-up of 20.7 months, CPX-351 significantly improved medi

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Kawazoe, M., K. Aoki, W. Hirose, et al. "AB1328 LONGITUDINAL SEROLOGICAL STUDY OF ANTI-SARS-CoV-2 SPIKE PROTEIN ANTIBODIES AFTER TWO DOSES OF mRNA VACCINES IN PATIENTS WITH RHEUMATIC DISEASES: ANALYSIS OF EFFECTS OF IMMUNOSUPPRESSANT THERAPY." Annals of the Rheumatic Diseases 82, Suppl 1 (2023): 1893.1–1894. http://dx.doi.org/10.1136/annrheumdis-2023-eular.1217.

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BackgroundThe longitudinal efficacy and safety data of vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in patients with rheumatic disease (RD) remains unclear.ObjectivesThe objective of the study was to examine changes over time in anti-SARS-CoV-2 spike protein IgG (anti-S IgG) values in RD patients compared with controls and investigate the effects of immunosuppressants on the values. Safety of vaccine was also evaluated.MethodsRD patients receiving glucocorticoids or immunosuppressants who were scheduled to receive two doses of SARS-CoV-2 mRNA vaccines were incl

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Vaca, Alicia, Nikolaos Ioannou, Mariela Sivina, et al. "Expansion of T Follicular Helper Cells in NLC Co-Cultures Reinforces the Concept of Co-Evolution of CLL and Supportive T Helper Cell Clones." Blood 138, Supplement 1 (2021): 3716. http://dx.doi.org/10.1182/blood-2021-151351.

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Abstract CLL cells proliferate in secondary lymphatic tissues where the CLL cells interact with T cells, monocyte-derived nurselike cells and mesenchymal stromal cells, collectively referred to as the tissue microenvironment. The CLL lymph node morphology with proliferation centers resembles normal B cell follicles, suggesting that mechanisms regulating the expansion of antigen-selected normal B cells during the germinal center (GC) reaction also regulate CLL cell expansion. Normal GC reactions require specialized T follicular helper (Tfh) cells, which provide T cell help to antigen-stimulated

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Eichhorst, Barbara, Carsten Niemann, Arnon P. Kater, et al. "A Randomized Phase III Study of Venetoclax-Based Time-Limited Combination Treatments (RVe, GVe, GIVe) Vs Standard Chemoimmunotherapy (CIT: FCR/BR) in Frontline Chronic Lymphocytic Leukemia (CLL) of Fit Patients: First Co-Primary Endpoint Analysis of the International Intergroup GAIA (CLL13) Trial." Blood 138, Supplement 1 (2021): 71. http://dx.doi.org/10.1182/blood-2021-146161.

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Abstract Background: For fit CLL patients (pts), continuous BTK inhibitor treatment is replacing CIT as standard of care in frontline setting, particularly in pts with unfavorable prognostic factors. The time limited combinations venetoclax plus obinutuzumab (GVe) and venetoclax plus rituximab (RVe) have produced high rates of undetectable minimal residual disease (uMRD), which strongly associates with long progression-free survival (PFS) both in frontline and relapsed setting. For frontline therapy GVe is approved in this setting based on data from the CLL14 trial in an unfit population. Howe

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Abe, M., E. Tanaka, E. Inoue, et al. "THU0086 FACTORS ASSOCIATED WITH TREATMENT RESPONSE IN PATIENTS WITH ELDERLY-ONSET RHEUMATOID ARTHRITIS: 3-YEAR OBSERVATION USING THE IORRA COHORT." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 255–56. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3115.

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Background:Patients with elderly-onset rheumatoid arthritis (EORA) are on the rise in the aging or super-aging society, especially in Japan. Patients with EORA have more comorbidities than those with younger-onset RA, a higher risk of adverse drug reactions due to reduced drug metabolism, and a higher risk of infections1). Therefore, patients with EORA tend to receive suboptimal treatment, resulting in insufficient control of disease activity2). Although several studies reported treatment responsiveness in patients with EORA, many of them have a limited observation period3-8), and long-term tr

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Lennon, Paul. "Assessing Short-term Change in Advanced Oral Proficiency." ITL - International Journal of Applied Linguistics 109-110 (January 1, 1995): 75–109. http://dx.doi.org/10.1075/itl.109-110.04len.

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Abstract This paper presents four case studies to demonstrate developments in oral proficiency made by advanced learners of English during two months in England. The data base consists of picture story oral narratives. Performance shortly after arrival in Britain is compared with that at the end of the two months. Assessment was by: subjective reactions of a panel of experienced native-speaker EFL teachers quantitative analysis of transcriptions of recordings. An attempt is made to apply VORSTER’s (1980) components of proficiency developed for use with children mother tongue speakers. The main

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Van Lint, J., N. Jessurun, S. Tas, et al. "POS0289 A CONCEPTUAL FRAMEWORK OF THE COURSE AND TIMEFRAME OF PATIENT-REPORTED ADVERSE DRUG REACTIONS OF BIOLOGICS IN IMMUNE-MEDIATED INFLAMMATORY DISEASES." Annals of the Rheumatic Diseases 81, Suppl 1 (2022): 389–90. http://dx.doi.org/10.1136/annrheumdis-2022-eular.1357.

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BackgroundPatients with immune-mediated inflammatory diseases (IMIDs) need chronic drug treatment, including biologics, which may cause adverse drug reactions (ADRs). Information about ADRs is usually restricted to the type of ADRs that may occur with drug use. Common patterns in the course and timeframe of ADRs are often not described while this information may provide valuable insights for patients and healthcare professionals.ObjectivesTo identify common and corresponding items with thematic analysis in the described course of ADRs of biologics reported by patients with IMIDs.MethodsWe used

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Usmani, Saad Z., Maria-Victoria Mateos, Hareth Nahi, et al. "Randomized, Open-Label, Non-Inferiority, Phase 3 Study of Subcutaneous (SC) Versus Intravenous (IV) Daratumumab (DARA) Administration in Patients with Relapsed or Refractory Multiple Myeloma: Columba Update." Blood 134, Supplement_1 (2019): 1865. http://dx.doi.org/10.1182/blood-2019-122765.

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INTRODUCTION: Daratumumab (DARA), a human IgGκ monoclonal antibody targeting CD38, is approved for intravenous (IV; 16 mg/kg) administration as a single agent or in combination with standard-of-care regimens for treatment of multiple myeloma (MM).To improve safety and reduce patient and healthcare provider burden, a subcutaneous (SC) formulation of DARA (1,800 mg co-formulated with recombinant human hyaluronidase PH20 [rHuPH20]; ENHANZE® drug delivery technology, Halozyme, Inc.) was developed. The phase 3, randomized, open-label, non-inferiority COLUMBA study (NCT03277105) evaluated the effica

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Furst, D., E. Keystone, J. Kay, et al. "AB0198 EFFICACY AND SAFETY AFTER TRANSITION FROM REFERENCE ADALIMUMAB TO CT-P17 (ADALIMUMAB BIOSIMILAR: 100 MG/ML) IN COMPARISON WITH THE MAINTAINED TREATMENT (CT-P17 OR REFERENCE ADALIMUMAB) IN PATIENTS WITH MODERATE-TO-SEVERE ACTIVE RHEUMATOID ARTHRITIS: 1-YEAR RESULT." Annals of the Rheumatic Diseases 80, Suppl 1 (2021): 1123–24. http://dx.doi.org/10.1136/annrheumdis-2021-eular.325.

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Background:Therapeutic equivalence of CT-P17 to reference adalimumab (ref-adalimumab) has been shown in patients with moderate-to-severe active rheumatoid arthritis (RA) through primary 24-week results [1]. Here, efficacy, pharmacokinetics (PK), safety and immunogenicity results up to 52-week, including transition data from ref-adalimumab to CT-P17 are presented.Objectives:To evaluate efficacy, PK, safety and immunogenicity when switched from ref-adalimumab to CT-P17 compared to maintaining CT-P17 or ref-adalimumab.Methods:In this study, 648 moderate-to-severe active RA patients despite methot

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Pipe, Steven W., Michael Recht, Nigel S. Key, et al. "First Data from the Phase 3 HOPE-B Gene Therapy Trial: Efficacy and Safety of Etranacogene Dezaparvovec (AAV5-Padua hFIX variant; AMT-061) in Adults with Severe or Moderate-Severe Hemophilia B Treated Irrespective of Pre-Existing Anti-Capsid Neutralizing Antibodies." Blood 136, Supplement_2 (2020): LBA—6—LBA—6. http://dx.doi.org/10.1182/blood-2020-143560.

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Background: Etranacogene dezaparvovec is an investigational gene therapy for hemophilia B (HB) comprising an adeno-associated virus serotype 5 (AAV5) vector containing a codon-optimized Padua variant human factor IX (FIX) gene with a liver specific promoter. In a Phase 2b study, a single dose of etranacogene dezaparvovec provided mean FIX activity of 41.0% sustained at 1yr post-dose in 3 participants (pts). Although most gene therapy clinical studies exclude pts with pre-existing neutralizing antibodies (NAbs) to the capsid serotype, early clinical studies and nonhuman primate data suggest tha

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Callaghan, Michael U., Claude Négrier, Ido Paz-Priel, et al. "Safety and Efficacy of Emicizumab in Persons with Hemophilia a with or without FVIII Inhibitors: Pooled Data from Four Phase III Studies (HAVEN 1-4)." Blood 136, Supplement 1 (2020): 3–5. http://dx.doi.org/10.1182/blood-2020-137438.

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Introduction: Emicizumab-a subcutaneously administered, bispecific, humanized, monoclonal antibody-promotes effective hemostasis in people with hemophilia A (PwHA). The primary efficacy and safety of emicizumab were reported previously, but long-term data are limited. Here, data from a wide age-range of PwHA with/without factor (F)VIII inhibitors enrolled in the Phase III HAVEN 1 (NCT02622321), HAVEN 2 (NCT02795767), HAVEN 3 (NCT02847637), and HAVEN 4 (NCT03020160) studies are pooled to establish the durable efficacy and safety of emicizumab. Methods: The studies enrolled pediatric and adult P

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Ikeda, Kazuhiko, Hitoshi Ohto, Yoshiki Okuyama, et al. "A Prospective, Multicenter Surveillance Study for Adverse Events Associated with Hematopoietic Stem Cell Infusion: Analysis of Pediatric and Low Body-Weight Recipients." Blood 132, Supplement 1 (2018): 2105. http://dx.doi.org/10.1182/blood-2018-99-118328.

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Abstract Adverse events (AEs) associated with blood component transfusion have been widely surveyed. In contrast, surveillance of AEs associated with hematopoietic stem cell (HSC) infusion in HSC transplant (HSCT),including bone marrow transplant (BMT), peripheral blood stem cell transplant (PBSCT), and cord blood transplant (CBT),has been less rigorous, even though HSC products contain cells of diverse maturity and viability,plasma with various antigens, cytokines and antibodies, and dimethyl sulfoxide (DMSO) in the case of cryopreserved products. In fact, HSC infusion is associated with seve

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LaCasce, Ann, R. Gregory Bociek, Jeffrey Matous, et al. "Brentuximab Vedotin in Combination with Bendamustine for Patients with Hodgkin Lymphoma who are Relapsed or Refractory after Frontline Therapy." Blood 124, no. 21 (2014): 293. http://dx.doi.org/10.1182/blood.v124.21.293.293.

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Abstract Background Patients (pts) with Hodgkin lymphoma (HL) who have relapsed/refractory disease after frontline therapy typically undergo salvage chemotherapy followed by high-dose conditioning and autologous stem cell transplant (ASCT). Improved outcomes have been reported for pts who achieve complete remission (CR) with salvage chemotherapy prior to ASCT. Variable CR rates (19%-60%) and significant toxicities are associated with standard salvage therapy in the first relapse setting. Brentuximab vedotin and bendamustine have independent mechanisms of action and are highly active with manag

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Yong, Kwee, Samantha Hinsley, Ruth M. De Tute, et al. "Maintenance with Carfilzomib Following Carfilzomib, Cyclophosphamide and Dexamethasone at First Relapse or Primary Refractory Multiple Myeloma (MM) on the Phase 2 Muk Five Study: Effect on Minimal Residual Disease." Blood 132, Supplement 1 (2018): 802. http://dx.doi.org/10.1182/blood-2018-99-116426.

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Abstract Background The benefit of single agent maintenance is largely established from studies in newly diagnosed patients, while extended therapy combination regimens are more commonly used in relapsed disease. Extended therapy on combination protocols may be limited by tolerability and safety, as well as patient compliance. Fixed duration combination treatment followed by single agent maintenance may provide better long term disease control. Such benefit may correlate with depth of response, measured as minimal residual disease (MRD). Prognostic significance of MRD negativity in the relapse

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Röth, Alexander, Miklos Egyed, Satochi Ichikawa, et al. "The SMART Anti-hC5 Antibody (SKY59/RO7112689) Shows Good Safety and Efficacy in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)." Blood 132, Supplement 1 (2018): 535. http://dx.doi.org/10.1182/blood-2018-99-113274.

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Abstract Introduction: SKY59 is an anti-C5 antibody applying SMART* [Fukuzawa et al., SciRep 2017] to allow for infrequent SC dosing. A three-part adaptive clinical trial was conducted in healthy volunteers (part1 -previously reported, Röth et al., Blood 2017 130:4750) and PNH patients who are treatment naive (part 2) or previously treated with eculizumab (ecu) (part 3) to establish dose, safety and efficacy of SKY59. Methods: Part 2 was an intra-patient dose escalation study. Patients received IV doses of 375mg, 500mg, and 1000mg of SKY59 on days 1, 8 and 22, respectively, followed by weekly

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Négrier, Claude, Johnny Mahlangu, Michaela Lehle, et al. "Emicizumab Prophylaxis in Persons with Mild or Moderate Hemophilia A: Results from the Interim Analysis of the HAVEN 6 Study." Blood 138, Supplement 1 (2021): 343. http://dx.doi.org/10.1182/blood-2021-146009.

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Abstract Background: Emicizumab, a bispecific monoclonal antibody, bridges activated factor (F)IX and FX, substituting for the function of missing activated FVIII in persons with hemophilia A (HA). The HAVEN 6 study (NCT04158648) aims to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of emicizumab prophylaxis in persons with mild or moderate HA without FVIII inhibitors. Here we report the results of the interim analysis (IA). Methods: HAVEN 6 is a Phase III, multicenter, open-label study of emicizumab in persons with mild (FVIII level &gt;5%-&lt;40%) or m

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Rizzacasa, Mark A. "Preface." Pure and Applied Chemistry 85, no. 6 (2013): iv. http://dx.doi.org/10.1351/pac20138506iv.

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The 19th International Conference on Organic Synthesis (ICOS-19) was jointly held with the 24th Royal Australian Chemical Institute Organic Division Conference (RACIOrganic24) in Melbourne, Australia from 1 to 6 July 2012. The meeting was co-chaired by Prof. Mark Rizzacasa (ICOS-19 Chair) from the University of Melbourne and Dr. Paul Savage (RACIOrganic24 Chair) from CSIRO Materials Science and Engineering, Melbourne.This meeting was attended by over 500 scientists from more than 30 countries, making it the largest organic chemistry conference ever to be held in Australia. The extensive progra

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Daver, Naval G., Pau Montesinos, Daniel J. DeAngelo, et al. "Clinical Profile of IMGN632, a Novel CD123-Targeting Antibody-Drug Conjugate (ADC), in Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) or Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)." Blood 134, Supplement_1 (2019): 734. http://dx.doi.org/10.1182/blood-2019-128648.

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INTRODUCTION: Overexpression of CD123, the alpha subunit of the IL-3 receptor, is seen in multiple hematological malignancies, including AML, BPDCN, and ALL. IMGN632 is a CD123-targeting ADC, comprising a high affinity anti-CD123 antibody coupled to a DNA-alkylating payload of the novel IGN (indolinobenzodiazepine pseudodimer) class. METHODS: Adult patients with CD123-positive R/R AML or R/R BPDCN with no more than three prior lines of therapy, were eligible. IMGN632 was given in two schedules: A) dosing day 1 and B) fractionated dosing on days 1, 4, and 8, both on a 21-day cycle. RESULTS: 74

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Kumagai, Takashi, Chiaki Nakaseko, Kaichi Nishiwaki, et al. "Silent NK/T Cell Reactions Against Dasatinib during Sustained Deep Molecular Response before Discontinuation Are Associated with Longer Treatment-Free Remission: A Multicenter, Single-Arm, Phase 2 Study." Blood 134, Supplement_1 (2019): 4154. http://dx.doi.org/10.1182/blood-2019-130504.

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Introduction Tyrosine kinase inhibitors (TKIs) markedly enhance the prognosis of chronic myelogenous leukemia (CML), potentially enabling the attainment of deep molecular response (DMR). Subsequently, the discontinuation of TKI became imperative to evade adverse events and financial burden of TKI therapy. In several studies, beginning with the STIM1 (Lancet Oncol 2010;11:1029), nearly 40%-60% of patients with chronic CML who sustained long DMR could discontinue TKI and attain long-term treatment-free remission (TFR). Remarkably, initial dasatinib specifically induces the elevation in lymphocyt

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Yong, Kwee, Samantha Hinsley, Holger W. Auner, et al. "Carfilzomib, Cyclophosphamide and Dexamethasone (KCD) Versus Bortezomib, Cyclophosphamide and Dexamethasone (VCD) for Treatment of First Relapse or Primary Refractory Multiple Myeloma (MM): First Final Analysis of the Phase 2 Muk Five Study." Blood 130, Suppl_1 (2017): 835. http://dx.doi.org/10.1182/blood.v130.suppl_1.835.835.

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Abstract Background Proteasome inhibitors (PIs) are central to anti-MM therapy and 3 are currently licensed: bortezomib, carfilzomib and ixazomib, increasing treatment options. Bortezomib (BZ) and carfilzomib (CFZ) have been studied in head-to-head comparison using a CFZ dose of 56mg/m2 in doublet with dexamethasone in relapse (ENDEAVOR), and also at 36mg/m2 in triplet with melphalan and prednisolone in newly diagnosed non-transplant eligible patients. Differing results may relate to dosing and scheduling, as well as to different study populations. There is growing evidence for triplet regimen

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Denton, C. P., O. Kowal-Bielecka, S. Proudman, et al. "POS1278 SAFETY AND PHARMACOKINETICS OF IGPRO20 (SUBCUTANEOUS IMMUNOGLOBULIN) AND IGPRO10 (INTRAVENOUS IMMUNOGLOBULIN) IN ADULTS WITH SYSTEMIC SCLEROSIS (SSC) – RESULTS FROM A PHASE 2 TRIAL." Annals of the Rheumatic Diseases 82, Suppl 1 (2023): 985.1–985. http://dx.doi.org/10.1136/annrheumdis-2023-eular.2525.

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BackgroundSystemic sclerosis (SSc) is a severe, progressive multisystem rheumatic disease with high mortality, but without approved disease-modifying treatment to stop or reverse course of disease. Intravenous immunoglobulin G (IgG) may have a positive impact on SSc based upon available literature reports. However, to date, there have been no clinical trials evaluating subcutaneous IgG (SCIG) in SSc. In particular, the impact of pathologically altered skin in SSc on local safety and pharmacokinetics (PK) of SCIG has not been explored yet.ObjectivesThe primary and secondary objectives of this t

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Berdel, Andrew F., Christoph Rollig, Martin Wermke, et al. "A Phase I Trial of the Antibody-Cytokine Fusion Protein F16IL2 in Combination with Anti-CD33 Immunotherapy for Posttransplant AML Relapse." Blood 138, Supplement 1 (2021): 2345. http://dx.doi.org/10.1182/blood-2021-145859.

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Abstract Introduction Natural killer (NK) cells are key effectors in cancer immunosurveillance and posttransplant immunity, but shortage of environmental growth factors and deficient recognition of malignant cells may limit their anticancer efficacy. We hypothesized that the antibody-mediated anchoring of interleukin-2 (IL-2) to the leukemia-modified extracellular matrix (ECM) would increase NK cell abundance and activity to potentiate antibody-dependent cellular cytotoxicity (ADCC) against acute myeloid leukemia (AML) blasts. In this novel-novel combination dose-escalation phase 1 trial, we e

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Jurczak, Wojciech, Pier Luigi Zinzani, Gianluca Gaidano, et al. "Single-Agent MOR208 in Relapsed or Refractory (R-R) Non-Hodgkin's Lymphoma (NHL): Results from Diffuse Large B-Cell Lymphoma (DLBCL) and Indolent NHL Subgroups of a Phase IIa Study." Blood 128, no. 22 (2016): 623. http://dx.doi.org/10.1182/blood.v128.22.623.623.

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Abstract Introduction: The B-lymphocyte, lineage specific surface antigen CD19 is broadly and homogeneously expressed in most B-cell non-Hodgkin's lymphomas (NHL). As a co-stimulatory molecule of the B-cell receptor complex it is an important regulator of transmembrane signals in B-cells. Phosphorylation of intracellular tyrosine residues of CD19 may augment signal transduction in multiple pro-survival and proliferation pathways ( e.g. PI3K and BTK). This makes CD19 an attractive target for the treatment of B-cell malignancies. MOR208 is a Fc-enhanced CD19 monoclonal antibody. The Fc-enhanceme

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Masri, K., K. Winterling, and B. Lamoreaux. "THU0434 LEFLUNOMIDE CO-THERAPY WITH PEGLOTICASE IN UNCONTROLLED GOUT." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 454.3–454. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3891.

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Background:Pegloticase is a PEGylated biologic for uncontrolled gout that has well-established efficacy. However, anti-drug antibody (ADA) development causes many patients to discontinue treatment before receiving the full therapeutic course.1ADAs bind to the pegloticase molecule, leading to reduced therapeutic efficacy and discontinuation of therapy.2Emerging data indicates that co-treatment with pegloticase and immunomodulating agents may prevent ADA development, allowing more patients to receive a full course of treatment. Prior case reports describe the results of pegloticase treatment wit

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Chari, Ajai, Jesús San-Miguel, Helen McCarthy, et al. "Subcutaneous Daratumumab Plus Standard Treatment Regimens in Patients with Multiple Myeloma across Lines of Therapy: Pleiades Study Update." Blood 134, Supplement_1 (2019): 3152. http://dx.doi.org/10.1182/blood-2019-123560.

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Introduction : Daratumumab (DARA) 16 mg/kg intravenous (IV) is approved as monotherapy for relapsed or refractory multiple myeloma (RRMM) and in combination with standard-of-care regimens for transplant-ineligible newly diagnosed multiple myeloma (NDMM). A subcutaneous (SC) co-formulation of DARA (DARA SC; 1,800 mg) with recombinant human hyaluronidase PH20 (rHuPH20; ENHANZE® drug delivery technology, Halozyme, Inc.) is under investigation in a number of ongoing studies. In the phase 3 COLUMBA study, DARA SC was shown to be noninferior to DARA IV, demonstrating similar efficacy and pharmacokin

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Kulasekararaj, Austin, Guangsheng He, Talha Munir, et al. "Trial in Progress: The Phase III, Randomized, Open-Label, Multicenter COMMODORE 2 Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Adult and Adolescent Patients with Paroxysmal Nocturnal Hemoglobinuria Not Previously Treated with Complement Inhibitors." Blood 136, Supplement 1 (2020): 34. http://dx.doi.org/10.1182/blood-2020-136647.

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Background Crovalimab is a novel anti-human complement component 5 (C5) antibody engineered to significantly extend half-life and enable subcutaneous (SC) administration once every 4 weeks in C5-mediated diseases. Based on the promising results of the Phase I/II COMPOSER trial (NCT03157635; Röth et al. Blood. 2020), crovalimab is currently under investigation as a potential therapy for paroxysmal nocturnal hemoglobinuria (PNH), a life-threatening disorder characterized by hemolytic anemia and thrombosis. Eculizumab and ravulizumab are C5 inhibitors currently approved for the treatment of patie

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Chari, Ajai, Hareth Nahi, Maria-Victoria Mateos, et al. "Subcutaneous Delivery of Daratumumab in Patients (pts) with Relapsed or Refractory Multiple Myeloma (RRMM): Pavo, an Open-Label, Multicenter, Dose Escalation Phase 1b Study." Blood 130, Suppl_1 (2017): 838. http://dx.doi.org/10.1182/blood.v130.suppl_1.838.838.

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Abstract Introduction : Daratumumab (DARA), a CD38-targeted human monoclonal antibody, is approved as monotherapy and in combination with bortezomib (proteasome inhibitor; PI) or immunomodulatory drugs (IMiD; lenalidomide or pomalidomide) in pts with RRMM. DARA is administered intravenously (IV) and is associated with infusion related reactions (IRRs) in 46% of pts. We previously reported data from PAVO (NCT02519452), an open-label, multicenter, phase 1b study in RRMM, showing that subcutaneous (SC) delivery of DARA with recombinant human hyaluronidase enzyme (rHuPH20) by SC infusion of a mix

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Comenzo, Raymond, Giovanni Palladini, Efstathios Kastritis, et al. "Subcutaneous Daratumumab with Bortezomib, Cyclophosphamide, and Dexamethasone in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis: 18-Month Analysis of the Phase 3 ANDROMEDA Study." Blood 138, Supplement 1 (2021): 159. http://dx.doi.org/10.1182/blood-2021-146820.

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Abstract Introduction: Light chain (AL) amyloidosis is a plasma cell disease characterized by the deposition of insoluble amyloid fibrils into organs leading to organ dysfunction and death. The analysis at 6 and 12 months of the ANDROMEDA study (NCT03201965) showed that the addition of subcutaneous (SC) daratumumab to the standard of care combination of bortezomib, cyclophosphamide, and dexamethasone (VCd) was superior to VCd alone, with higher rates of hematologic complete response (CR) and an acceptable safety profile. Based on these findings daratumumab with VCd (D-VCd) was approved for new

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Schore, Reuven J., Meenakshi Devidas, Archie Bleyer, et al. "Anti-Pegaspargase, Anti-Calaspargase Pegol , and Anti-Polyethelene Glycol Antibody Incidence in High Risk Acute Lymphoblastic Leukemia Patients Receiving Pegaspargase or Calaspargase Pegol and Associated Anaphylactic or Hypersensitivity Reaction Rates: Results from Children's Oncology Group (COG) Study AALL07P4." Blood 128, no. 22 (2016): 3965. http://dx.doi.org/10.1182/blood.v128.22.3965.3965.

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Abstract Introduction Asparaginase is a critical component in the treatment of acute lymphoblastic leukemia (ALL). COG AALL07P4 evaluated the pharmacokinetic (PK) and pharmacodynamic comparability of pegaspargase (ASP) and calaspargase pegol (CASP) as part of an augmented BFM chemotherapy regimen for the treatment of newly-diagnosed, NCI high-risk, B-precursor ALL (Angiolillo, JCO 2014). Both ASP and CASP consist of E. coli L-asparaginase linked to polyethelene glycol (PEG) utilizing a succinimidyl succinate or succinimidyl carbamate linker, respectively. Antibodies to either asparaginase or P

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Dimopoulos, Meletios A., Evangelos Terpos, Mario Boccadoro, et al. "Apollo: Phase 3 Randomized Study of Subcutaneous Daratumumab Plus Pomalidomide and Dexamethasone (D-Pd) Versus Pomalidomide and Dexamethasone (Pd) Alone in Patients (Pts) with Relapsed/Refractory Multiple Myeloma (RRMM)." Blood 136, Supplement 1 (2020): 5–6. http://dx.doi.org/10.1182/blood-2020-135874.

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Introduction Immunomodulatory drug (IMiD)-based regimens are a standard of care (SOC) for RRMM. Daratumumab (DARA) is a CD38-targeted mAb approved for treatment of pts with RRMM. The subcutaneous (SC) formulation of DARA has a similar safety profile as intravenous DARA, with a statistically significant reduction in infusion-related reaction (IRR) rates and a considerably shorter administration duration of 5 mins. DARA SC is approved for use in the US, EU, Canada, and Korea. In the phase 1b study of DARA plus the IMiD pomalidomide, D-Pd induced deep responses and was well tolerated in pts with

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Richardson, Paul G., Joseph Mikhael, Saad Z. Usmani, et al. "Preliminary Results from a Phase Ib Study of Isatuximab in Combination with Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma." Blood 128, no. 22 (2016): 2123. http://dx.doi.org/10.1182/blood.v128.22.2123.2123.

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Abstract Background: Isatuximab (ISA) is an anti-CD38 monoclonal antibody with multiple modes of action for killing tumor cells through immune cell engagement and direct tumor targeting. In preclinical studies, pomalidomide (Pom) enhanced both the direct and indirect anti-tumor activity of ISA to a greater degree than lenalidomide (Len) (Jiang et al. Leukemia 2016). Here, we report the preliminary results of an ongoing Phase Ib dose-escalation study of ISA plus Pom and dexamethasone (Dex) in patients with relapsed and refractory multiple myeloma (RRMM) (NCT02283775). Methods: Patients with RRM

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Botson, J., P. M. Peloso, K. Obermeyer, B. Lamoreaux, M. E. Weinblatt, and J. Peterson. "THU0416 PEGLOTICASE RESPONSE IMPROVEMENT BY CO-TREATMENT WITH METHOTREXATE: RESULTS FROM THE MIRROR OPEN-LABEL CLINICAL TRIAL IN PATIENTS WITH UNCONTROLLED GOUT." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 446.3–446. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3932.

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Background:Gout is a painful inflammatory arthritis caused by persistently elevated serum uric acid (sUA) levels. Pegloticase, an infused recombinant PEGylated uricase, rapidly lowers sUA levels by converting uric acid to allantoin, a water-soluble molecule that is readily excreted by the kidneys. In the phase 3 clinical trials, 42% of patients1dosed with pegloticase every two weeks maintained sUA levels below 6.0 mg/dL during months 3 and 6 of pegloticase treatment. The loss of pegloticase efficacy has been attributed to the development of anti-drug antibodies (ADAs)1-3and these ADAs have bee

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Chari, Ajai, Maria-Victoria Mateos, Niels WCJ van de Donk, et al. "Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Safety and Efficacy Update of the Open-Label, Multicenter, Phase 1b Study (PAVO)." Blood 132, Supplement 1 (2018): 1995. http://dx.doi.org/10.1182/blood-2018-99-113590.

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Abstract Introduction: Daratumumab (DARA) is a human IgGκ anti-CD38 monoclonal antibody with a direct on-tumor and immunomodulatory mechanism of action. DARA (16 mg/kg administered intravenously [IV]) is approved in many countries as monotherapy and in combination with standard of care (SOC) treatment regimens for patients with relapsed/refractory (RR) multiple myeloma (MM) and newly diagnosed MM. Three phase 3 studies have now demonstrated that DARA in combination with SOC treatment doubles complete response (CR) rates, triples minimal residual disease-negative rates, and reduces the risk of

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Jagannath, Sundar, Jesus G. Berdeja, Robert M. Rifkin, et al. "Elotuzumab Plus Pomalidomide and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Initial Data from a Phase 2, Non-Comparative Study." Blood 132, Supplement 1 (2018): 1991. http://dx.doi.org/10.1182/blood-2018-99-112077.

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Abstract Introduction: Despite therapeutic advances, most patients (pts) with multiple myeloma (MM) eventually develop relapsed/refractory (RR) disease, and observational studies of pts refractory to immunomodulatory drugs and proteasome inhibitors have demonstrated a median overall survival (OS) of 13 mo (Kumar et al, Leukemia 2017;31:2443-8). Elotuzumab, an immunostimulatory monoclonal antibody targeted to SLAMF7, directly activates natural killer cells and mediates the killing of MM cells through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Elotuzum

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Tanizawa, Nao, Hideo Koh, Hiroshi Okamura, et al. "Pretransplant Risk Factors for Calcineurin Inhibitor-Induced Encephalopathy and Limbic Encephalitis Following Allogeneic Hematopoietic Cell Transplantation." Blood 134, Supplement_1 (2019): 4492. http://dx.doi.org/10.1182/blood-2019-124264.

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Background: Central nervous system (CNS) complications after allogeneic hematopoietic cell transplantation (allo-HCT) can be fatal. Although numerous studies have reported risk factors for CNS complications after allo-HCT, most defined CNS complication events as a composite endpoint, for example, composed of cerebrovascular disease, infection, posterior reversible encephalopathy syndrome (PRES), and metabolic encephalopathy. For a more precise and targeted approach, risk factor analyses for each individual CNS event are needed. Few studies have reported risk factor analyses for individual CNS

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Pemmaraju, Naveen, Hagop Kantarjian, Kendra Sweet, et al. "Integrated Safety Analysis of Tagraxofusp, a CD123-Directed Targeted Therapy, in Patients with Hematologic Malignancies." Blood 138, Supplement 1 (2021): 2318. http://dx.doi.org/10.1182/blood-2021-145344.

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Abstract Introduction: The interleukin-3 receptor alpha chain (CD123) is a cell-surface target aberrantly expressed on various myeloid neoplasms including blastic plasmacytoid dendritic cell neoplasm (BPDCN), acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), and myelofibrosis (MF). Tagraxofusp (TAG, SL-401), a first-in-class CD123-targeted therapy, is the only treatment approved by the FDA and EMA for patients (pts) with BPDCN. It has also been investigated in phase 1/2 clinical trials for AML (including pts with minimal residual disease [MRD]), CMML, and MF. We report the

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Armand, Philippe, Andreas Engert, Anas Younes, et al. "Nivolumab for Relapsed or Refractory Classical Hodgkin Lymphoma (cHL) after Autologous Hematopoietic Cell Transplantation (auto-HCT): Extended Follow-up of the Phase 2 Single-Arm CheckMate 205 Study." Blood 132, Supplement 1 (2018): 2897. http://dx.doi.org/10.1182/blood-2018-99-112067.

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Abstract Introduction: Genetic alterations at 9p24.1 resulting in overexpression of programmed death-1 (PD-1) ligands are near-universal in cHL (Roemer et al, J Clin Oncol 2016); cHL may thus be uniquely sensitive to PD-1 blockade. Nivolumab (nivo), an anti-PD-1 monoclonal antibody, was associated with an objective response rate (ORR) of 69% in relapsed/refractory (R/R) cHL after auto-HCT and irrespective of prior brentuximab vedotin (BV) in the phase 2 CheckMate 205 study (Armand et al, J Clin Oncol 2018; NCT02181738). Whether some patient (pts) can derive very long clinical benefit, whether

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Bahlis, Nizar, Jeffrey A. Zonder, Susan Wroblewski, et al. "Randomized Phase 2 Study of Subcutaneous Daratumumab Plus Carfilzomib/Dexamethasone Versus Carfilzomib/Dexamethasone Alone in Patients with Multiple Myeloma Who Have Been Previously Treated with Intravenous Daratumumab to Evaluate Retreatment (LYNX)." Blood 134, Supplement_1 (2019): 1831. http://dx.doi.org/10.1182/blood-2019-123486.

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Background: Daratumumab is a human IgGκ monoclonal antibody targeting CD38 with a direct on-tumor and immunomodulatory mechanism of action. The intravenous (IV) formulation of daratumumab is approved in many countries for use as monotherapy in relapsed/refractory multiple myeloma (RRMM), and in combination with standard-of-care regimens in RRMM and patients with NDMM who are transplant ineligible. A subcutaneous (SC) formulation of daratumumab is currently under investigation in several ongoing studies. In the phase 3 COLUMBA study, daratumumab SC was shown to be non-inferior to daratumumab IV

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Advani, Ranjana H., Alison J. Moskowitz, Nancy L. Bartlett, et al. "Phase 1/2 Study of Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Classic Hodgkin Lymphoma: Part 3 (Concurrent Dosing) Results and Updated Progression-Free Survival Results from Parts 1 and 2 (Staggered Dosing)." Blood 132, Supplement 1 (2018): 1635. http://dx.doi.org/10.1182/blood-2018-99-110002.

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Abstract Introduction This phase 1/2 study evaluated the safety and antitumor activity of brentuximab vedotin (BV) administered in combination with nivolumab (Nivo) in adult patients (pts) with relapsed/refractory classic Hodgkin lymphoma (R/R cHL) who have failed frontline therapy (NCT02572167). Results from Parts 1 & 2 have been previously reported, wherein safety, efficacy, and biomarkers consistent with immune activation were observed in pts with R/R cHL (Herrera et al., Blood 2018). In Part 3, patients were treated with BV + Nivo on Day 1 of each cycle. In contrast, pts in Parts 1 &am

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Hillmen, Peter, Tadeusz Robak, Ann Janssens, et al. "Ofatumumab + Chlorambucil Versus Chlorambucil Alone In Patients With Untreated Chronic Lymphocytic Leukemia (CLL): Results Of The Phase III Study Complement 1 (OMB110911)." Blood 122, no. 21 (2013): 528. http://dx.doi.org/10.1182/blood.v122.21.528.528.

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Abstract Introduction Chemoimmunotherapy with purine analogues and the anti-CD20 antibody rituximab is the standard of care as initial therapy in younger and physically fit patients with chronic lymphocytic leukemia (CLL). However, most CLL patients are elderly and/or have comorbidities, meaning that fludarabine-containing regimens are often inappropriate, carry greater toxicity, and treatment of these patients remains challenging. Most randomized studies in previously untreated CLL have been conducted in younger or fit patients and results cannot necessarily be extrapolated to older, less fit

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Botson, J., P. M. Peloso, K. Obermeyer, et al. "AB0630 PEGLOTICASE/METHOTREXATE CO-THERAPY IMPROVED JOINT AND PATIENT-REPORTED HEALTH ASSESSMENTS IN PATIENTS WITH UNCONTROLLED GOUT: 12-MONTH EXPLORATORY OUTCOMES OF THE MIRROR OPEN-LABEL TRIAL." Annals of the Rheumatic Diseases 80, Suppl 1 (2021): 1348.2–1349. http://dx.doi.org/10.1136/annrheumdis-2021-eular.996.

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Background:Gout development follows persistent serum uric acid (sUA) elevation. Patients who are refractory to or cannot tolerate oral urate lowering therapies (ULTs) have limited treatment options. Pegloticase is effective in treating refractory gout, but many patients develop anti-drug antibodies (ADAs), which are associated with loss of urate-lowering efficacy1-3 and infusion reactions (IRs).1,2 In phase 3 trials, the pooled pegloticase responder rate during Months 3 and 6 combined was 42% (8 mg infusion every 2 weeks), with high-titer ADA positive patients losing efficacy prior to 6 months

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Bartolucci, Pablo, Kenneth I. Ataga, Michael U. Callaghan, et al. "Trial in Progress: The Randomized, Double-Blind, Placebo-Controlled Phase Ib CROSSWALK-a Trial Evaluating the Safety of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOEs) in Patients with Sickle Cell Disease (SCD)." Blood 138, Supplement 1 (2021): 3108. http://dx.doi.org/10.1182/blood-2021-147854.

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Abstract Background SCD is a group of autosomal recessive red blood cell (RBC) disorders caused by a single point mutation in the β-globin gene, resulting in the production of hemoglobin S. Hemoglobin S polymerizes within RBCs under certain conditions, leading to the distortion of the RBC membrane and generation of dense and sickle RBCs. These pathologic RBCs contribute to microvascular occlusions in patients with SCD, which present as acute painful episodes called VOEs. Despite the majority of VOEs being managed at home, they remain the most common reason for emergency department (ED) visits

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Herrera, Alex F., Alison J. Moskowitz, Nancy L. Bartlett, et al. "Results from a Phase 1/2 Study of Brentuximab Vedotin in Combination with Nivolumab in Patients with Relapsed or Refractory Hodgkin Lymphoma." Blood 130, Suppl_1 (2017): 649. http://dx.doi.org/10.1182/blood.v130.suppl_1.649.649.

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Abstract Introduction Brentuximab vedotin (BV) is an ADC directed against CD30, a receptor expressed by malignant Reed-Sternberg (RS) cells present in the inflammatory/immune cell microenvironment of classical Hodgkin lymphomas (cHL). Through induction of immunogenic cell death, BV may prime an antitumor immune response via microtubule disruption of CD30-expressing RS cells (Gardai 2015). Tumor cells expressing PD-1 ligands use the PD-1 pathway to evade an immune response. Nivolumab (Nivo) blocks the PD-1 receptor, inhibits binding of PD-1 ligands, and restores an effective antitumor immune re

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Cherniha, Roman, and Vasyl’ Davydovych. "Exact Solutions of a Mathematical Model Describing Competition and Co-Existence of Different Language Speakers." Entropy 22, no. 2 (2020): 154. http://dx.doi.org/10.3390/e22020154.

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The known three-component reaction–diffusion system modeling competition and co-existence of different language speakers is under study. A modification of this system is proposed, which is examined by the Lie symmetry method; furthermore, exact solutions in the form of traveling fronts are constructed and their properties are identified. Plots of the traveling fronts are presented and the relevant interpretation describing the language shift that has occurred in Ukraine during the Soviet times is suggested.

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LaCasce, Ann S., Gregory Bociek, Ahmed Sawas, et al. "Brentuximab Vedotin Plus Bendamustine: A Highly Active Salvage Treatment Regimen for Patients with Relapsed or Refractory Hodgkin Lymphoma." Blood 126, no. 23 (2015): 3982. http://dx.doi.org/10.1182/blood.v126.23.3982.3982.

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Abstract Background Long-term outcomes from autologous stem cell transplant (ASCT) in patients (pts) with relapsed/refractory (R/R) Hodgkin lymphoma (HL) are significantly better in patients who achieve a complete remission (CR) from salvage chemotherapy prior to ASCT. However, standard salvage therapy produces variable CR rates (19%-60%) and is associated with significant toxicity. Brentuximab vedotin and bendamustine are highly active when administered as single agents to pts with R/R HL (34% and 33% CR rates, respectively) and have manageable safety profiles. This phase 1/2, single-arm, 2-s

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Clemens, Pamela L., Steven Xu, Melody Luo, et al. "Pharmacokinetics (PK) of Subcutaneous Daratumumab in Patients with Relapsed or Refractory (RR) Multiple Myeloma (MM): Primary Clinical Pharmacology Analysis of the Open-Label, Multicenter, Phase 1b Study (PAVO)." Blood 132, Supplement 1 (2018): 2006. http://dx.doi.org/10.1182/blood-2018-99-113161.

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Abstract Introduction: Subcutaneous (SC) administration offers several potential advantages for patients (pts) and healthcare providers, including shorter administration times, reduced administration volume, and fewer infusion-related reactions. Daratumumab (DARA), a human IgGκ anti-CD38 monoclonal antibody, has direct on-tumor and immunomodulatory effects. DARA is approved for intravenous (IV) administration as monotherapy for RRMM and in combination with standard of care regimens for RR and newly diagnosed MM. Previous analyses demonstrated that maximum DARA trough concentration (Ctrough), w

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Sakamoto, M., A. Senoh, Y. Sato, et al. "SAT0119 PARADOXICAL NEUTROPHIL ACTIVATION BY ANTI-IL6 THERAPY: TRANSCRIPTOME ANALYSIS SHOWS A RATIONALE FOR DERMATOLOGICAL ADVERSE REACTIONS AND DECREASED NEUTROPHIL COUNTS AFTER TOCILIZUMAB TREATMENT." Annals of the Rheumatic Diseases 79, Suppl 1 (2020): 993.1–994. http://dx.doi.org/10.1136/annrheumdis-2020-eular.3900.

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Background:Skin rashes as a side effect of Tocilizumab therapy (TCZ- Tx) has not been paid much attention, because the incidence was only 1~2% in the drug information sheets. However, we experienced several RA cases with development of various skin rashes associated with neutrophil activation after TCZ-Tx. On the other hand, it is well known that the neutrophil counts in peripheral blood decreases after TCZ-Tx, whereas it does not affect the rate of serious infections. The detailed mechanism is still unclear.Objectives:To detect the characteristics of the changes in gene expressions of periphe

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Van De Wyngaert, Zoe, Benjamin Carpentier, Laurent Pascal, et al. "Efficacy and Safety of Daratumumab in a Frail Real-Life Relapsed or Refractory Systemic Light-Chain Amyloidosis Population (AL): Report on 15 Cases from the North of France." Blood 132, Supplement 1 (2018): 5660. http://dx.doi.org/10.1182/blood-2018-99-116801.

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Abstract Introduction: Systemic Light-chain amyloidosis (AL) is a clonal plasma-cell disorder, and has therefore benefited from the numerous therapeutic advances in multiple myeloma (MM). Nonetheless, outcome of refractory AL patients remains dire, especially in patients with severe end-organ damage. Daratumumab, a monoclonal antibody directed against CD38, has yielded significant results in MM, but data in AL, although promising, are scarce. Methods: Between November 2016 and July 2018, 15 relapsed or refractory patients with histologically proven AL from five different French centres from th

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Hillmen, Peter, John G. Gribben, George A. Follows, et al. "Rituximab Plus Chlorambucil In Patients with CD20-Positive B-Cell Chronic Lymphocytic Leukemia (CLL): Final Response Analysis of An Open-Label Phase II Study." Blood 116, no. 21 (2010): 697. http://dx.doi.org/10.1182/blood.v116.21.697.697.

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Abstract Abstract 697 Introduction: Despite the increasing use of combination therapy with rituximab, fludarabine and cyclophosphamide (R-FC) for chronic lymphocytic leukemia (CLL), a significant proportion of patients (pts) are not suitable or eligible for such intensive chemotherapy due to co-morbidity and/or age. In those pts considered unfit for R-FC, chlorambucil (Chl) remains a widely used first-line therapy. However, overall responses rates with Chl are relatively modest with very few complete remissions and therefore more effective treatment options are required for this patient group.

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