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3 results on '"Alexandr Myasnikov"'

1. Efficacy and safety of a novel dosing strategy for ruxolitinib in the treatment of patients with myelofibrosis and anemia: the REALISE phase 2 study

Author

Pierre Zachee, David M. Ross, Lynda Foltz, Atanas Radinoff, Francesco Mannelli, Evren Zor, Francisco Cervantes, Francesco Passamonti, Heinz Gisslinger, Geralyn Gilotti, Haifa Kathrin Al-Ali, Francesca Palandri, Alexandr Myasnikov, Alessandro M. Vannucchi, Islam Sadek, Ranjan Tiwari, and Norio Komatsu

Subjects
Male, Cancer Research, Ruxolitinib, medicine.medical_specialty, Anemia, Phases of clinical research, Gastroenterology, Article, Myeloproliferative disease, Internal medicine, White blood cell, Nitriles, medicine, Humans, Chemotherapy, Dosing, Myelofibrosis, Adverse effect, Aged, Aged, 80 and over, Dose-Response Relationship, Drug, business.industry, Hematology, Middle Aged, medicine.disease, Pyrimidines, Treatment Outcome, medicine.anatomical_structure, Oncology, Primary Myelofibrosis, Pyrazoles, Female, Patient Safety, Hemoglobin, business, medicine.drug
Abstract

Anemia is a frequent manifestation of myelofibrosis (MF) and there is an unmet need for effective treatments in anemic MF patients. The REALISE phase 2 study (NCT02966353) evaluated the efficacy and safety of a novel ruxolitinib dosing strategy with a reduced starting dose with delayed up-titration in anemic MF patients. Fifty-one patients with primary MF (66.7%), post-essential thrombocythemia MF (21.6%), or post-polycythemia vera MF (11.8%) with palpable splenomegaly and hemoglobin

Published
2021

2. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis

Author

David Pohlreich, Lidia Oostvogels, Mohamed El Idrissi, Alemnew F Dagnew, Jaime Pérez de Oteyza, Maria Belen Navarro Matilla, Dong-Gun Lee, Lars Rombo, Osman Ilhan, Shelly A. McNeil, Aránzazu Alonso Alonso, Po Nan Wang, Anna Johnston, Marta López-Fauqued, Jae Yong Kwak, Raquel Oña Navarrete, Gianluca Gaidano, Javier de la Serna, Ariah Schattner, Philippe Rodon, Ahmed Masood, Teresa del Campo, Bruno Salaun, Terrance Comeau, Andrew Peniket, John Murphy, Boris Afanasyev, Hyeon Seok Eom, Pere Barba Suñol, Sam Milliken, Alessandro Lucchesi, Pierre Zachee, Aleksey Kuvshinov, Seok Jin Kim, Anna Carolina Miranda Castillo, Stella Bowcock, Tzeon Jye Chiou, Stephane Lepretre, Richard Eek, Veli-Jukka Anttila, Faisal Sultan, Sebastian Grosicki, Anne Schuind, Patricia Disperati, Jo Anne H. Young, William Hwang, Thierry Guillaume, Emmanuel Di Paolo, Philippe Quittet, Paul Turner, Dariusz Woszczyk, Dimas Quiel, Norbert Blesing, Naheed Mir, Lucrecia Yáñez San Segundo, Ching Yuan Kuo, Humphrey Pullon, Koen Theunissen, Jae Hoon Lee, Karlis Pauksens, Thomas C. Heineman, Wojciech Homenda, Nikolay Ilyin, Johan Sanmartin Berglund, Dominik Selleslag, Marjatta Sinisalo, Kathleen M. Mullane, Sang Kyun Sohn, Kadir Acar, Albert Kwok Wai Lie, Mickael Aoun, Won Sik Lee, Francesco Zaja, Alexandr Myasnikov, Gabriela Rodriguez Macías, Laura Campora, Je Jung Lee, Olga Samoylova, Peter Van den Steen, Dagnew, A. F., Ilhan, O., Lee, W. -S., Woszczyk, D., Kwak, J. -Y., Bowcock, S., Sohn, S. K., Rodriguez Macias, G., Chiou, T. -J., Quiel, D., Aoun, M., Navarro Matilla, M. B., de la Serna, J., Milliken, S., Murphy, J., Mcneil, S. A., Salaun, B., Di Paolo, E., Campora, L., Lopez-Fauqued, M., El Idrissi, M., Schuind, A., Heineman, T. C., Van den Steen, P., Oostvogels, L., Acar, K., Afanasyev, B., Alonso Alonso, A., Anttila, V. -J., Barba Sunol, P., Blesing, N., Comeau, T., del Campo, T., Disperati, P., Eek, R., Eom, H., Gaidano, G., Grosicki, S., Guillaume, T., Homenda, W., Hwang, W., Ilyin, N., Johnston, A., Kim, S. J., Kuo, C. -Y., Kuvshinov, A., Lee, D. -G., Lee, J. H., Lee, J. -J., Lepretre, S., Lie, A. K. -W., Lucchesi, A., Masood, A., Mir, N., Miranda Castillo, A. C., Mullane, K., Myasnikov, A., Ona Navarrete, R., Pauksens, K., Peniket, A., Perez de Oteyza, J., Pohlreich, D., Pullon, H., Quittet, P., Rodon, P., Rombo, L., Samoylova, O., Sanmartin Berglund, J., Schattner, A., Selleslag, D., Sinisalo, M., Sultan, F., Theunissen, K., Turner, P., Wang, P. -N., Yanez San Segundo, L., Young, J. -A., Zachee, P., and Zaja, F.

Subjects
Adult, Male, Herpesvirus 3, Human, medicine.medical_specialty, Adolescent, Population, Antineoplastic Agents, Antibodies, Viral, Placebo, Hematological malignancies, Immunocompromised Host, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Viral Envelope Proteins, Internal medicine, medicine, Herpes Zoster Vaccine, Humans, Single-Blind Method, 030212 general & internal medicine, education, Adverse effect, Fatigue, Immunity, Cellular, Vaccines, Synthetic, education.field_of_study, Vaccines, Reactogenicity, H. Zoster, business.industry, Immunogenicity, Middle Aged, CD4 Lymphocyte Count, Injection Site Reaction, Vaccination, Clinical trial, Infectious Diseases, Hematologic Neoplasms, 030220 oncology & carcinogenesis, Female, Zoster vaccine, business, Vaccine, medicine.drug
Abstract

BACKGROUND: The adjuvanted recombinant zoster vaccine (Shingrix) can prevent herpes zoster in older adults and autologous haemopoietic stem cell transplant recipients. We evaluated the safety and immunogenicity of this vaccine in adults with haematological malignancies receiving immunosuppressive cancer treatments. METHODS: In this phase 3, randomised, observer-blind, placebo-controlled study, done at 77 centres worldwide, we randomly assigned (1:1) patients with haematological malignancies aged 18 years and older to receive two doses of the adjuvanted recombinant zoster vaccine or placebo 1-2 months apart during or after immunosuppressive cancer treatments, and stratified participants according to their underlying diseases. The co-primary objectives of the study were the evaluation of safety and reactogenicity of the adjuvanted recombinant zoster vaccine compared with placebo from the first vaccination up to 30 days after last vaccination in all participants; evaluation of the proportion of participants with a vaccine response in terms of anti-glycoprotein E humoral immune response to the adjuvanted recombinant zoster vaccine at month 2 in all participants, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia; and evaluation of the anti-glycoprotein E humoral immune responses to the vaccine compared with placebo at month 2 in all participants, excluding those with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia. We assessed immunogenicity in the per-protocol cohort for immunogenicity and safety in the total vaccinated cohort. The study is registered with ClinicalTrials.gov, number NCT01767467, and with the EU Clinical Trials Register, number 2012-003438-18. FINDINGS: Between March 1, 2013, and Sept 10, 2015, we randomly assigned 286 participants to adjuvanted recombinant zoster vaccine and 283 to placebo. 283 in the vaccine group and 279 in the placebo group were vaccinated. At month 2, 119 (80·4%, 95% CI 73·1-86·5) of 148 participants had a humoral vaccine response to adjuvanted recombinant zoster vaccine, compared with one (0·8%, 0·0-4·2) of 130 participants in the placebo group, and the adjusted geometric mean anti-glycoprotein E antibody concentration was 23 132·9 mIU/mL (95% CI 16 642·8-32 153·9) in the vaccine group and 777·6 mIU/mL (702·8-860·3) in the placebo group (adjusted geometric mean ratio 29·75, 21·09-41·96; p

Published
2019

3. Prognostic value of end-of-induction PET response after first-line immunochemotherapy for follicular lymphoma (GALLIUM): secondary analysis of a randomised, phase 3 trial

Author

Judith Trotman, Sally F Barrington, David Belada, Michel Meignan, Robert MacEwan, Carolyn Owen, Václav Ptáčník, András Rosta, Günter R Fingerle-Rowson, Jiawen Zhu, Tina Nielsen, Deniz Sahin, Wolfgang Hiddemann, Robert E Marcus, Andrew Davies, Mark Hertzberg, Andrew Grigg, Paul Cannell, Hang Quach, Stephen Opat, Constantine Tam, Paula Marlton, Ann Janssens, Fritz Offner, Koen Van eygen, Randeep Sangha, Pam Mckay, Jonathan Wilson, Richard Van Der Jagt, Daryl Roitman, Marek Trneny, Jiri Mayer, Katell Le Du, Philippe Solal-Celigny, Guillaume Cartron, Charles Foussard, Norbert Frickhofen, Peter Schmidt, Ullrich Graeven, Tobias Gaska, Rudolf Schlag, Martin Sökler, Gabriele Prange-Krex, Axel Florschütz, Hans-Walter Lindemann, Christoph Schimmelpfennig, Solveig Tonndorf, Mathias Hänel, Georg Hess, Enrico Schalk, Heiko Hütten, Gottfried Doelken, Michael Pfreundschuh, Ulrich Keller, Michael Herold, Roswitha Forstpointner, Ursula Vehling-Kaiser, Martin Hoffmann, Zita Borbenyi, Miklos Udvardy, Judit Demeter, Alessandro Rambaldi, Enrica Morra, Federico Massimo, Ignazio Majolino, Monica Balzarotti, Gianpietro Semenzato, Miguel Angel Canales Albendea, Francisco Javier Peñalver Parraga, Alfonso Soler Campos, Juan Manuel Sancho Cia, Jose Antonio Marquez Navarro, Carlos Grande Garcia, Herman Nilsson-Ehle, Helen Mccarthy, Chris Pocock, Shalal Sadullah, Ram Malladi, John Radford, Ed Kanfer, Anton Kruger, Dominic Culligan, Martin Dyer, Ruth Pettengell, John Seymour, John Gribben, Saad Al-Ismail, Faris Al-Refaie, Norbert Blesing, Christopher Macnamara, Ann O'callaghan, Andrew Haynes, George Follows, Roderick Johnson, David Cunningham, Kristian Bowles, Graham Collins, Eve Gallop-Evans, Stephen Robinson, Chezhian Subash, James Bailey, Viran Holden, Jeffrey Neidhart, Moacyr De Oliveira, Haluk Tezcan, Kevin Kim, Suman Kambhampati, Keith Lanier, John Mcclean, Kensei Tobinai, Kiyohiko Hatake, Michinori Ogura, Toshiki Uchida, Kiyoshi Ando, Tomohiro Kinoshita, Thomas Höhler, Heribert Stauder, Andreas Kirsch, Michael Koenigsmann, Stephan Kremers, Thomas Illmer, Mathias Witzens-Harig, Paul La Roseé, Jan Dürig, Michael Kneba, Manfred Hensel, Stefan Fuxius, Lothar Bergmann, Kai Hübel, Christian Buske, Reinhard Marks, Gerald Wulf, Christian Lerchenmueller, Rudolf Schmits, Mark Reinwald, Eva Lengfelder, Fiona Scott, Takaaki Chou, Masafumi Taniwaki, Isao Yoshida, Kenichi Ishizawa, Naokuni Uike, Nobuhiko Uoshima, Yuri Kamitsuji, Shinsuke Iida, Ken Ohmine, Kisato Nosaka, Kazuhiko Ide, Takayuki Ishikawa, Pierre Desjardins, Nicholas Finn, Jun Zhu, Wei Li, Li Yu, Hanyun Ren, Yuan Kai Shi, Gang Wu, Xiaonan Hong, Qingyuan Zhang, Jifeng Feng, Rong Zhan, Tongyu Lin, Sirpa Leppa, Regis Costello, Adrian Tempescul, Laurence Sanhes, Olivier Tournilhac, Heinz Kirchen, Holger Hebart, Rudolf Weide, Kathleen Jentsch-Ullrich, Irit Avivi, Arnon Nagler, Ronit Gurion, Ofer Shpilberg, Pietro Leoni, Luca Baldini, Olga Samoylova, Alexandr Myasnikov, Tran-Der Tan, Hung Chang, Kyoya Kumagai, Norifumi Tsukamoto, Kunihiro Tsukasaki, Patrick Beatty, Noriko Usui, Koji Izutsu, Tohru Murayama, Tatsuo Ichinohe, Kohmei Kubo, Fumihiro Ishida, J. Thaddeus Beck, Frank Griesinger, Dzhelil Osmanov, Shaker Dakhil, Aline Clavert, Dai Maruyama, Yasuhito Terui, Kazuhito Yamamoto, Ekkehard Eigendorff, Tsutomu Kobayashi, Satoshi Ichikawa, Ilseung Choi, Katsuya Wada, Yoshitaka Kikukawa, Masao Matsuoka, Takayuki Yoshino, Yosuke Minami, Dürig, Jan (Beitragende*r), The University of Sydney, Service de médecine nucléaire [Créteil], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Prince of Wales Medical Research Institute, University of New South Wales [Sydney] (UNSW), University of Melbourne, Universiteit Gent = Ghent University [Belgium] (UGENT), Service d'hématologie et oncologie médicale, Hôpital Lapeyronie-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Université Montpellier 1 (UM1)-Université de Montpellier (UM), Semmelweis University of Medicine [Budapest], Queens Elizabeth Hospital [Birmingham], Queen Mary University of London (QMUL), IBM Thomas J. Watson Research Center, IBM, Department of Computing and Information Systems, and Université Montpellier 1 (UM1)-Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier)-Hôpital Lapeyronie-Université de Montpellier (UM)

Subjects
Male, Time Factors, [SDV]Life Sciences [q-bio], Follicular lymphoma, Medizin, chemistry.chemical_compound, 0302 clinical medicine, Antineoplastic Agents, Immunological, Obinutuzumab, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, Prospective Studies, Lymphoma, Follicular, Randomized Controlled Trials as Topic, education.field_of_study, Manchester Cancer Research Centre, Hazard ratio, Middle Aged, Progression-Free Survival, 3. Good health, Oncology, 030220 oncology & carcinogenesis, Female, Immunotherapy, Rituximab, medicine.drug, Bendamustine, medicine.medical_specialty, Population, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Predictive Value of Tests, Internal medicine, medicine, Humans, Progression-free survival, education, Aged, Neoplasm Staging, Retrospective Studies, business.industry, ResearchInstitutes_Networks_Beacons/mcrc, medicine.disease, chemistry, Clinical Trials, Phase III as Topic, Positron-Emission Tomography, business, Tomography, X-Ray Computed, Progressive disease, 030215 immunology
Abstract

BACKGROUND: Initial results from the ongoing GALLIUM trial have shown that patients with follicular lymphoma have a longer progression-free survival after first-line immunochemotherapy with obinutuzumab than with rituximab. The aim of this secondary analysis was to evaluate the prognostic value of PET-CT responses after first-line immunochemotherapy in the GALLIUM study.METHODS: GALLIUM is an open-label, parallel-group randomised, phase 3 trial, which recruited previously untreated patients with CD20-positive follicular lymphoma (grades 1-3a; disease stage III/IV, or stage II with largest tumour diameter ≥7 cm) who were aged 18 years or older and met the criteria for needing treatment. Eligible patients were randomly assigned in a 1:1 ratio to receive intravenous administration of obinutuzumab (1000 mg on days 1, 8, and 15 of cycle 1, then day 1 of subsequent cycles) or rituximab (375 mg/m2 on day 1 of each cycle), in six 21-day cycles with cyclophosphamide, doxorubicin, vincristine, and prednisone (known as CHOP; oral administration) followed by two 21-day cycles of antibody alone, or eight 21-day cycles cyclophosphamide, vincristine, and prednisone (known as CVP; oral administration), or six 28-day cycles with bendamustine, followed by maintenance antibody every 2 months for up to 2 years. The primary endpoint of the trial, investigator-assessed progression-free survival, has been reported previously. This secondary analysis reports PET and CT-based responses at end-of-induction therapy and explains their relation with progression-free and overall survival outcomes in patients with available scans. As per protocol, during the trial, PET scans (mandatory in the first 170 patients enrolled at sites with available PET facilities, and optional thereafter), acquired at baseline and end of induction (PET population), were assessed prospectively by investigators and an independent review committee (IRC) applying International Harmonisation Project (IHP) 2007 response criteria, and retrospectively by the IRC only applying current Lugano 2014 response criteria. IRC members (but not study investigators) were masked to treatment and clinical outcome when assessing response. The landmark analyses excluded patients who died or progressed (contrast enhanced CT-based assessment of progressive disease, or started next anti-lymphoma treatment) before or at end of induction. GALLIUM is registered at ClinicalTrials.gov, number NCT01332968.FINDINGS: 1202 patients were enrolled in GALLIUM between July 6, 2011, and Feb 4, 2014, of whom 595 were included in the PET population; 533 (IHP 2007; prospective analysis), and 508 (Lugano 2014; retrospective analysis) were analysed for progression-free survival (landmark analysis). At end of induction, 390 of 595 patients (65·5% [95% CI 61·6-69·4]) achieved PET complete response according to IHP 2007 criteria, and 450 (75·6% [95% CI 72·0-79·0]) obtained PET complete metabolic response according to Lugano 2014 criteria. With a median of 43·3 months of observation (IQR 36·2-51·8), 2·5-year progression-free survival from end of induction was 87·8% (95% CI 83·9-90·8) in PET complete responders and 72·0% (63·1-79·0) in non-complete responders according to IRC-assessed IHP 2007 criteria (hazard ratio [HR] 0·4, 95% CI 0·3-0·6, pINTERPRETATION: Our results suggest that PET is a better imaging modality than contrast-enhanced CT for response assessment after first-line immunochemotherapy in patients with follicular lymphoma. PET assessment according to Lugano 2014 response criteria provides a platform for investigation of response-adapted therapeutic approaches. Additional supportive data are welcomed.FUNDING: F Hoffmann-La Roche.

Published
2018
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