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Chronic lymphocytic phase iii

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https://www.readbyqxmd.com/read/28747208/ga101-obinutuzumab-monoclonal-antibody-as-consolidation-therapy-in-cll-galactic-trial-study-protocol-for-a-phase-ii-iii-randomised-controlled-trial
#1
Jamie B Oughton, Laura Collett, Dena R Howard, Anna Hockaday, Talha Munir, Kathryn McMahon, Lucy McParland, Claire Dimbleby, David Phillips, Andy C Rawstron, Peter Hillmen
BACKGROUND: Chronic lymphocytic leukaemia (CLL) is the most common adult leukaemia. Achieving minimal residual disease (MRD) negativity in CLL is an independent predictor of survival even with a variety of different treatment approaches and regardless of the line of therapy. METHODS/DESIGN: GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) is a seamless phase II/III, multi-centre, randomised, controlled, open, parallel-group trial for patients with CLL who have recently responded to chemotherapy...
July 26, 2017: Trials
https://www.readbyqxmd.com/read/28712935/phase-ii-study-of-sequential-infusion-of-donor-lymphocyte-infusion-and-cytokine-induced-killer-cells-for-patients-relapsed-after-allogeneic-hematopoietic-stem-cell-transplantation
#2
Martino Introna, Federico Lussana, Alessandra Algarotti, Elisa Gotti, Rut Valgarsdottir, Caterina Micò, Anna Grassi, Chiara Pavoni, Maria Luisa Ferrari, Federica Delaini, Elisabetta Todisco, Irene Cavattoni, Sara Deola, Ettore Biagi, Adriana Balduzzi, Attilio Rovelli, Matteo Parma, Sara Napolitano, Giusy Sgroi, Emanuela Marrocco, Paolo Perseghin, Daniela Belotti, Benedetta Cabiati, Giuseppe Gaipa, Josée Golay, Andrea Biondi, Alessandro Rambaldi
Seventy-four patients who relapsed after allogeneic stem cell transplantation were enrolled in a phase IIA study and treated with the sequential infusion of donor lymphocyte infusion (DLI) followed by cytokine-induced killer (CIK) cells. Seventy-three patients were available for the intention to treat analysis. At least 1 infusion of CIK cells was given to 59 patients, whereas 43 patients received the complete cell therapy planned (58%). Overall, 12 patients (16%) developed acute graft-versus-host disease (aGVHD) of grades I to II in 7 cases and grades III to IV in 5)...
July 13, 2017: Biology of Blood and Marrow Transplantation
https://www.readbyqxmd.com/read/28695412/-basis-for-the-treatment-of-eczematous-diseases-in-otorhinolaryngology
#3
REVIEW
R Fölster-Holst, A Sperl, T Albrecht, L Klimek
According to Coombs and Gell, cell-mediated immune responses belong to type IV reactions and are borne mainly by T lymphocytes. The eliciting allergens are usually so-called haptens. Haptens are substances which develop to whole antigens only by binding to protein carriers. In otorhinolaryngology, delayed allergic hypersensitivities are apparent mainly as contact eczemata. Facial dermatitis, auricle and ear canal eczema as well as perioral eczema belong to the most common forms of contact dermatitis in ENT patients...
July 10, 2017: HNO
https://www.readbyqxmd.com/read/28628003/clinical-effectiveness-and-cost-effectiveness-results-from-the-randomised-phase-iib-trial-in-previously-untreated-patients-with-chronic-lymphocytic-leukaemia-to-compare-fludarabine-cyclophosphamide-and-rituximab-with-fludarabine-cyclophosphamide-mitoxantrone
#4
Dena R Howard, Talha Munir, Lucy McParland, Andy C Rawstron, Anna Chalmers, Walter M Gregory, John L O'Dwyer, Alison Smith, Roberta Longo, Abraham Varghese, Alexandra Smith, Peter Hillmen
BACKGROUND: The conventional frontline therapy for fit patients with chronic lymphocytic leukaemia (CLL) is fludarabine, cyclophosphamide and rituximab (FCR). Rituximab (Mabthera(®), Roche Products Ltd) targets the CD20 antigen, which is expressed at low levels in CLL. The standard dose of rituximab in CLL (375 mg/m(2) in cycle 1 and 500 mg/m(2) in cycles 2-6) was selected based on toxicity data only. Small doses of rituximab (as low as 20 mg) have biological activity in CLL, with an immediate reduction in circulating CLL cells and down-regulation of CD20...
May 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28492339/venetoclax-for-the-treatment-of-patients-with-chronic-lymphocytic-leukemia
#5
Jennifer Crombie, Matthew S Davids
Venetoclax is a potent, selective inhibitor of BCL-2, a key regulator of the intrinsic pathway of apoptosis. In preclinical studies, venetoclax bound to BCL-2 with high affinity and rapidly induced apoptosis in chronic lymphocytic leukemia (CLL) cells. In early-phase clinical trials in CLL, venetoclax treatment led to tumor lysis syndrome in some patients with a large tumor burden, but this risk was subsequently mitigated by a revised study design that included lower initial dosing with intrapatient dose ramp-up and close tumor lysis syndrome monitoring and prophylaxis...
May 11, 2017: Future Oncology
https://www.readbyqxmd.com/read/28388280/duvelisib-a-phosphoinositide-3-kinase-%C3%AE-%C3%AE-inhibitor-for-chronic-lymphocytic-leukemia
#6
REVIEW
Hima V Vangapandu, Nitin Jain, Varsha Gandhi
Frontline chemotherapy is successful against chronic lymphocytic leukemia (CLL), but results in untoward toxicity. Further, prognostic factors, cytogenetic anomalies, and compensatory cellular signaling lead to therapy resistance or disease relapse. Therefore, for the past few years, development of targeted therapies is on the rise. PI3K is a major player in the B-cell receptor (BCR) signaling axis, which is critical for the survival and maintenance of B cells. Duvelisib, a PI3K δ/γ dual isoform specific inhibitor that induces apoptosis and reduces cytokine and chemokine levels in vitro, holds promise for CLL...
May 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28105602/ibrutinib-a-review-in-chronic-lymphocytic-leukaemia
#7
REVIEW
Emma D Deeks
Ibrutinib (Imbruvica(®)) is an oral irreversible inhibitor of Bruton's tyrosine kinase, a B-cell receptor (BCR) signalling kinase expressed by various haematopoietic cells, B-cell lymphomas and leukaemias. The drug is indicated for the treatment of certain haematological malignancies, including chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL), which are the focus of this review. In phase III CLL/SLL trials, ibrutinib monotherapy was more effective than chlorambucil in the first-line treatment of elderly patients (RESONATE-2) and more effective than ofatumumab in previously-treated adults (RESONATE)...
February 2017: Drugs
https://www.readbyqxmd.com/read/28062113/indirect-treatment-comparisons-of-ibrutinib-versus-physician-s-choice-and-idelalisib-plus-ofatumumab-in-patients-with-previously-treated-chronic-lymphocytic-leukemia
#8
REVIEW
Sonja Sorensen, Mark Wildgust, Nishan Sengupta, Cristina Trambitas, Joris Diels, Suzy van Sanden, Yingxin Xu, Emily Dorman
PURPOSE: Treatment options for patients with relapsed or refractory chronic lymphocytic leukemia (R/R CLL) are limited. Until recently, few effective treatment options existed, and even with the advent of new agents, studies evaluating comparative efficacy are scarce. In the Ibrutinib Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (RESONATE) Phase III study, ibrutinib, an oral, once-a-day, first-in-class covalent Bruton tyrosine kinase inhibitor, improved progression-free survival (PFS) and overall survival (OS) compared with ofatumumab (PFS hazard ratio [HR] = 0...
January 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28017967/duvelisib-treatment-is-associated-with-altered-expression-of-apoptotic-regulators-that-helps-in-sensitization-of-chronic-lymphocytic-leukemia-cells-to-venetoclax-abt-199
#9
V M Patel, K Balakrishnan, M Douglas, T Tibbitts, E Y Xu, J L Kutok, M Ayers, A Sarkar, R Guerrieri, W G Wierda, S O'Brien, N Jain, H M Stern, V Gandhi
Duvelisib, an oral dual inhibitor of PI3K-δ and PI3K-γ, is in phase III trials for the treatment of chronic lymphocytic leukemia (CLL) and indolent non-Hodgkin's lymphoma. In CLL, duvelisib monotherapy is associated with high iwCLL (International Workshop on Chronic Lymphocytic Leukemia) and nodal response rates, but complete remissions are rare. To characterize the molecular effect of duvelisib, we obtained samples from CLL patients on the duvelisib phase I trial. Gene expression studies (RNAseq, Nanostring, Affymetrix array and real-time RT-PCR) demonstrated increased expression of BCL2 along with several BH3-only pro-apoptotic genes...
February 3, 2017: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
https://www.readbyqxmd.com/read/27815572/phase-i-ii-study-of-lenalidomide-and-alemtuzumab-in-refractory-chronic-lymphocytic-leukemia-cll-effects-on-t-cells-and-immune-checkpoints
#10
Maria Winqvist, Fariba Mozaffari, Marzia Palma, Sandra Eketorp Sylvan, Lotta Hansson, Håkan Mellstedt, Anders Österborg, Jeanette Lundin
This phase I-II study explored safety, immunomodulatory and clinical effects of lenalidomide (weeks 1-16) and alemtuzumab (weeks 5-16) in 23 patients with refractory chronic lymphocytic leukemia. Most patients had Rai stage III/IV disease and were heavily pretreated (median 4 prior therapies), and 61% had del(17p)/del(11q). Eleven of 19 evaluable patients (58%) responded, with a median response duration of 12 months (1-29+); time to progression was short in non-responders. Lenalidomide had a narrow therapeutic dose range, 2...
January 2017: Cancer Immunology, Immunotherapy: CII
https://www.readbyqxmd.com/read/27731748/ofatumumab-plus-fludarabine-and-cyclophosphamide-in-relapsed-chronic-lymphocytic-leukemia-results-from-the-complement-2-trial
#11
Tadeusz Robak, Krzysztof Warzocha, K Govind Babu, Yaroslav Kulyaba, Kazimierz Kuliczkowski, Kudrat Abdulkadyrov, Javier Loscertales, Iryna Kryachok, Janusz Kłoczko, Grygoriy Rekhtman, Wojciech Homenda, Jerzy Z Błoński, Astrid McKeown, Michele M Gorczyca, Jodi L Carey, Chai-Ni Chang, Steen Lisby, Ira V Gupta, Sebastian Grosicki
In this multicenter, open-label, phase III study, patients with relapsed chronic lymphocytic leukemia (CLL) were randomized (1:1) to receive ofatumumab plus fludarabine and cyclophosphamide (OFA + FC) or FC alone; the primary endpoint being progression-free survival (PFS) assessed by an independent review committee (IRC). Between March 2009 and January 2012, 365 patients were randomized (OFA + FC: n = 183; FC: n = 182). Median IRC-assessed PFS was 28.9 months with OFA + FC versus 18.8 months with FC (hazard ratio = 0...
May 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/27645620/chemotherapy-plus-ofatumumab-at-standard-or-mega-dose-in-relapsed-cll-cosmic-trial-study-protocol-for-a-phase-ii-randomised-controlled-trial
#12
Dena R Howard, Talha Munir, Anna Hockaday, Andy C Rawstron, Laura Collett, Jamie B Oughton, David Allsup, Adrian Bloor, David Phillips, Peter Hillmen
BACKGROUND: Chronic lymphocytic leukaemia (CLL) is the most common adult leukaemia. Combination immunochemotherapy such as fludarabine, cyclophosphamide and rituximab is the standard first line therapy in fit patients, but there is limited evidence regarding the optimal treatment of patients after relapse. Ofatumumab as monotherapy has been proven to be effective in the treatment of relapsed, refractory CLL, and as it is not myelotoxic, it is an ideal drug to combine with chemotherapy...
2016: Trials
https://www.readbyqxmd.com/read/27611574/viral-infection-of-the-central-nervous-system-exacerbates-interleukin-10-receptor-deficiency-mediated-colitis-in-sjl-mice
#13
Ann-Kathrin Uhde, Vanessa Herder, Muhammad Akram Khan, Malgorzata Ciurkiewicz, Dirk Schaudien, René Teich, Stefan Floess, Wolfgang Baumgärtner, Jochen Huehn, Andreas Beineke
Theiler´s murine encephalomyelitis virus (TMEV)-infection is a widely used animal model for studying demyelinating disorders, including multiple sclerosis (MS). The immunosuppressive cytokine Interleukin (IL)-10 counteracts hyperactive immune responses and critically controls immune homeostasis in infectious and autoimmune disorders. In order to investigate the effect of signaling via Interleukin-10 receptor (IL-10R) in infectious neurological diseases, TMEV-infected SJL mice were treated with IL-10R blocking antibody (Ab) in the acute and chronic phase of the disease...
2016: PloS One
https://www.readbyqxmd.com/read/27573660/minimal-residual-disease-assessment-improves-prediction-of-outcome-in-patients-with-chronic-lymphocytic-leukemia-cll-who-achieve-partial-response-comprehensive-analysis-of-two-phase-iii-studies-of-the-german-cll-study-group
#14
Gabor Kovacs, Sandra Robrecht, Anna Maria Fink, Jasmin Bahlo, Paula Cramer, Julia von Tresckow, Christian Maurer, Petra Langerbeins, Günter Fingerle-Rowson, Matthias Ritgen, Michael Kneba, Hartmut Döhner, Stephan Stilgenbauer, Wolfram Klapper, Clemens-Martin Wendtner, Kirsten Fischer, Michael Hallek, Barbara Eichhorst, Sebastian Böttcher
PURPOSE: To determine the value of minimal residual disease (MRD) assessments, together with the evaluation of clinical response in chronic lymphocytic leukemia according to the 2008 International Workshop on Chronic Lymphocytic Leukemia criteria. PATIENTS AND METHODS: Progression-free survival (PFS) and overall survival of 554 patients from two randomized trials of the German CLL Study Group (CLL8: fludarabine and cyclophosphamide [FC] v FC plus rituximab; CLL10: FC plus rituximab v bendamustine plus rituximab) were analyzed according to MRD assessed in peripheral blood at a threshold of 10(-4) and clinical response...
August 29, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27570087/ofatumumab-monotherapy-as-a-consolidation-strategy-in-patients-with-previously-untreated-chronic-lymphocytic-leukaemia-a-phase-2-trial
#15
Paolo Strati, Mark Lanasa, Timothy G Call, Jose F Leis, Danielle M Brander, Betsy R LaPlant, Adam M Pettinger, Wei Ding, Sameer A Parikh, Curtis A Hanson, Asher A Chanan-Khan, Deborah A Bowen, Michael Conte, Neil E Kay, Tait D Shanafelt
BACKGROUND: Although several consolidation strategies to prolong treatment-free survival (TFS) in chronic lymphocytic leukaemia have been investigated, most have proven either ineffective or toxic. Ofatumumab is a human type I anti-CD20 antibody approved by the US Food and Drug Administration as maintenance treatment of patients with recurrent or progressive chronic lymphocytic leukaemia who are in complete or partial response after at least two lines of treatment; higher efficacy might be observed if used as consolidation strategy than without consolidation in previously untreated patients...
September 2016: Lancet Haematology
https://www.readbyqxmd.com/read/27494089/health-related-quality-of-life-and-patient-reported-outcomes-of-ofatumumab-plus-chlorambucil-versus-chlorambucil-monotherapy-in-the-complement-1-trial-of-patients-with-previously-untreated-cll
#16
Peter Hillmen, Ann Janssens, K Govind Babu, Janusz Kloczko, Sebastian Grosicki, Stephanie Manson, Astrid McKeown, Ira Gupta, Chai-Ni Chang, Fritz Offner
BACKGROUND: Patients diagnosed with chronic lymphocytic leukemia (CLL) are usually elderly and frequently have a number of comorbidities. Health-related quality of life (HRQoL) for these patients is of utmost importance and should be taken into consideration when assessing new treatment options. The combination of ofatumumab with chlorambucil has shown longer progression-free survival compared with chlorambucil alone. In this study, we aim to assess how this treatment combination affects patients' health-related quality of life and patient-reported symptoms...
September 2016: Acta Oncologica
https://www.readbyqxmd.com/read/27260335/venetoclax-first-global-approval
#17
REVIEW
Emma D Deeks
Venetoclax (Venclexta™) is an oral selective inhibitor of the prosurvival protein BCL-2 and therefore restores the apoptotic ability of malignant cells. The drug arose from research by Abbott Laboratories (now AbbVie) during a collaboration with Genentech and is being co-developed by AbbVie and Genentech/Roche primarily for the treatment of haematological malignancies. Venetoclax is approved in the USA for use as monotherapy in patients with chronic lymphocytic leukaemia (CLL) with the 17p deletion (as detected by an approved FDA test) who have received at least one prior therapy, and is awaiting approval for similar indications in the EU and Canada...
June 2016: Drugs
https://www.readbyqxmd.com/read/27226433/complex-karyotypes-and-kras-and-pot1-mutations-impact-outcome-in-cll-after-chlorambucil-based-chemotherapy-or-chemoimmunotherapy
#18
Carmen Diana Herling, Marion Klaumünzer, Cristiano Krings Rocha, Janine Altmüller, Holger Thiele, Jasmin Bahlo, Sandra Kluth, Giuliano Crispatzu, Marco Herling, Joanna Schiller, Anja Engelke, Eugen Tausch, Hartmut Döhner, Kirsten Fischer, Valentin Goede, Peter Nürnberg, Hans Christian Reinhardt, Stephan Stilgenbauer, Michael Hallek, Karl-Anton Kreuzer
Genetic instability is a feature of chronic lymphocytic leukemia (CLL) with adverse prognosis. We hypothesized that chromosomal translocations or complex karyotypes and distinct somatic mutations may impact outcome after first-line chemoimmunotherapy of CLL patients. We performed metaphase karyotyping and next-generation sequencing (NGS) of 85 genes in pretreatment blood samples obtained from 161 patients registered for CLL11, a 3-arm phase 3 trial comparing frontline chlorambucil (Clb) vs Clb plus rituximab (Clb-R) or Clb plus obinutuzumab in CLL patients with significant comorbidity...
July 21, 2016: Blood
https://www.readbyqxmd.com/read/27161742/po-54-clinical-and-laboratory-characterization-of-platelet-dysfunction-caused-by-ibrutinib-treatment-in-patients-with-chronic-lymphocytic-leukemia
#19
M A Alberelli, I Innocenti, S Sica, L Laurenti, E De Candia
INTRODUCTION: Ibrutinib treatment in patients with chronic lymphatic leukemia (LLC) is associated with bleeding-related adverse events. About 50% of treated patients display minor bleedings and about 5% major bleedings. A defect of platelet function has been hypothesized and inhibition of signaling by glycoprotein (GP) VI, which is the receptor for collagen, has been previously described. Ibrutinib-associated bleedings and platelet dysfunction may be relevant in the context of aged patients, who are often under antithrombotic treatments...
April 2016: Thrombosis Research
https://www.readbyqxmd.com/read/27133817/effect-of-first-line-treatment-on-second-primary-malignancies-and-richter-s-transformation-in-patients-with-cll
#20
C Maurer, P Langerbeins, J Bahlo, P Cramer, A M Fink, N Pflug, A Engelke, J von Tresckow, G Kovacs, S Stilgenbauer, C-M Wendtner, L Müller, M Ritgen, T Seiler, K Fischer, M Hallek, B Eichhorst
This study aimed to assess the frequency of and the contributing factors for second primary malignancies (SPMs) and Richter's transformations (RTs) following first-line treatment of chronic lymphocytic leukemia within four phase II/III trials of the GCLLSG evaluating fludarabine (F) vs F+cyclophosphamide (FC), chlorambucil vs F, FC without or with rituximab, and bendamustine+R (BR). Among 1458 patients, 239 (16.4%) experienced either an SPM (N=191) or a RT (N=75). Solid tumors (N=115; 43.2% of all second neoplasias) appeared most frequently, followed by RTs (N=75; 28...
October 2016: Leukemia: Official Journal of the Leukemia Society of America, Leukemia Research Fund, U.K
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