Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.
Identifieur interne : 001023 ( PubMed/Corpus ); précédent : 001022; suivant : 001024Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.
Auteurs : Andrew D. Zelenetz ; Jacqueline C. Barrientos ; Jennifer R. Brown ; Bertrand Coiffier ; Julio Delgado ; Mikl S Egyed ; Paolo Ghia ; Árpád Illés ; Wojciech Jurczak ; Paula Marlton ; Marco Montillo ; Franck Morschhauser ; Alexander S. Pristupa ; Tadeusz Robak ; Jeff P. Sharman ; David Simpson ; Lukáš Smolej ; Eugen Tausch ; Adeboye H. Adewoye ; Lyndah K. Dreiling ; Yeonhee Kim ; Stephan Stilgenbauer ; Peter HillmenSource :
- The Lancet. Oncology [ 1474-5488 ] ; 2017.
English descriptors
- KwdEn :
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Bendamustine Hydrochloride (administration & dosage), Double-Blind Method, Drug Resistance, Neoplasm (drug effects), Female, Follow-Up Studies, Humans, Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy), Leukemia, Lymphocytic, Chronic, B-Cell (pathology), Male, Middle Aged, Neoplasm Recurrence, Local (drug therapy), Neoplasm Recurrence, Local (pathology), Neoplasm Staging, Prognosis, Purines (administration & dosage), Quinazolinones (administration & dosage), Rituximab (administration & dosage), Salvage Therapy, Survival Rate.
- MESH :
- chemical , administration & dosage : Bendamustine Hydrochloride, Purines, Quinazolinones, Rituximab.
- drug effects : Drug Resistance, Neoplasm.
- drug therapy : Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasm Recurrence, Local.
- pathology : Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasm Recurrence, Local.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Adult, Aged, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neoplasm Staging, Prognosis, Salvage Therapy, Survival Rate.
Abstract
Bendamustine plus rituximab is a standard of care for the management of patients with relapsed or refractory chronic lymphocytic leukaemia. New therapies are needed to improve clinically relevant outcomes in these patients. We assessed the efficacy and safety of adding idelalisib, a first-in-class targeted phosphoinositide-3-kinase δ inhibitor, to bendamustine plus rituximab in this population.
DOI: 10.1016/S1470-2045(16)30671-4
PubMed: 28139405
Links to Exploration step
pubmed:28139405Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.</title><author><name sortKey="Zelenetz, Andrew D" sort="Zelenetz, Andrew D" uniqKey="Zelenetz A" first="Andrew D" last="Zelenetz">Andrew D. Zelenetz</name><affiliation><nlm:affiliation>Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: zeleneta@mskcc.org.</nlm:affiliation></affiliation></author><author><name sortKey="Barrientos, Jacqueline C" sort="Barrientos, Jacqueline C" uniqKey="Barrientos J" first="Jacqueline C" last="Barrientos">Jacqueline C. Barrientos</name><affiliation><nlm:affiliation>Hofstra Northwell School of Medicine, Hofstra University, New Hyde Park, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Brown, Jennifer R" sort="Brown, Jennifer R" uniqKey="Brown J" first="Jennifer R" last="Brown">Jennifer R. Brown</name><affiliation><nlm:affiliation>Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name><affiliation><nlm:affiliation>Department of Haematology, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.</nlm:affiliation></affiliation></author><author><name sortKey="Delgado, Julio" sort="Delgado, Julio" uniqKey="Delgado J" first="Julio" last="Delgado">Julio Delgado</name><affiliation><nlm:affiliation>Department of Haematology, Hospital Clínic, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Egyed, Mikl S" sort="Egyed, Mikl S" uniqKey="Egyed M" first="Mikl S" last="Egyed">Mikl S Egyed</name><affiliation><nlm:affiliation>Department of Haematology, Somogy County Kaposi Mór Hospital, Kaposvar, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Ghia, Paolo" sort="Ghia, Paolo" uniqKey="Ghia P" first="Paolo" last="Ghia">Paolo Ghia</name><affiliation><nlm:affiliation>Division of Experimental Oncology and Department of Onco-Haematology, IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Illes, Arpad" sort="Illes, Arpad" uniqKey="Illes A" first="Árpád" last="Illés">Árpád Illés</name><affiliation><nlm:affiliation>Department of Haematology, University of Debrecen, Debrecen, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Jurczak, Wojciech" sort="Jurczak, Wojciech" uniqKey="Jurczak W" first="Wojciech" last="Jurczak">Wojciech Jurczak</name><affiliation><nlm:affiliation>Department of Haematology, Jagiellonian University, Krakow, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Marlton, Paula" sort="Marlton, Paula" uniqKey="Marlton P" first="Paula" last="Marlton">Paula Marlton</name><affiliation><nlm:affiliation>Department of Haematology, Princess Alexandra Hospital, University of Queensland, School of Medicine, Brisbane, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Montillo, Marco" sort="Montillo, Marco" uniqKey="Montillo M" first="Marco" last="Montillo">Marco Montillo</name><affiliation><nlm:affiliation>Department of Haematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Morschhauser, Franck" sort="Morschhauser, Franck" uniqKey="Morschhauser F" first="Franck" last="Morschhauser">Franck Morschhauser</name><affiliation><nlm:affiliation>CHRU Lille, Unité GRITA, Department of Haematology, Université de Lille, Lille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Pristupa, Alexander S" sort="Pristupa, Alexander S" uniqKey="Pristupa A" first="Alexander S" last="Pristupa">Alexander S. Pristupa</name><affiliation><nlm:affiliation>Department of Haematology, Ryazan Regional Clinical Hospital, Ryazan, Russia.</nlm:affiliation></affiliation></author><author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><affiliation><nlm:affiliation>Department of Haematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Sharman, Jeff P" sort="Sharman, Jeff P" uniqKey="Sharman J" first="Jeff P" last="Sharman">Jeff P. Sharman</name><affiliation><nlm:affiliation>US Oncology Research, Willamette Valley Cancer Institute and Research Center, Eugene, OR, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Simpson, David" sort="Simpson, David" uniqKey="Simpson D" first="David" last="Simpson">David Simpson</name><affiliation><nlm:affiliation>North Shore Hospital, Takapuna, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Smolej, Lukas" sort="Smolej, Lukas" uniqKey="Smolej L" first="Lukáš" last="Smolej">Lukáš Smolej</name><affiliation><nlm:affiliation>4th Department of Internal Medicine-Haematology, University Hospital and Charles University in Prague, Faculty of Medicine in Hradec Králové, Hradec Králové, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Tausch, Eugen" sort="Tausch, Eugen" uniqKey="Tausch E" first="Eugen" last="Tausch">Eugen Tausch</name><affiliation><nlm:affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Adewoye, Adeboye H" sort="Adewoye, Adeboye H" uniqKey="Adewoye A" first="Adeboye H" last="Adewoye">Adeboye H. Adewoye</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dreiling, Lyndah K" sort="Dreiling, Lyndah K" uniqKey="Dreiling L" first="Lyndah K" last="Dreiling">Lyndah K. Dreiling</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Yeonhee" sort="Kim, Yeonhee" uniqKey="Kim Y" first="Yeonhee" last="Kim">Yeonhee Kim</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Stilgenbauer, Stephan" sort="Stilgenbauer, Stephan" uniqKey="Stilgenbauer S" first="Stephan" last="Stilgenbauer">Stephan Stilgenbauer</name><affiliation><nlm:affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Hillmen, Peter" sort="Hillmen, Peter" uniqKey="Hillmen P" first="Peter" last="Hillmen">Peter Hillmen</name><affiliation><nlm:affiliation>Department of Haematology/Oncology, St James's University Hospital, Leeds, UK.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2017">2017</date><idno type="RBID">pubmed:28139405</idno><idno type="pmid">28139405</idno><idno type="doi">10.1016/S1470-2045(16)30671-4</idno><idno type="wicri:Area/PubMed/Corpus">001023</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">001023</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.</title><author><name sortKey="Zelenetz, Andrew D" sort="Zelenetz, Andrew D" uniqKey="Zelenetz A" first="Andrew D" last="Zelenetz">Andrew D. Zelenetz</name><affiliation><nlm:affiliation>Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: zeleneta@mskcc.org.</nlm:affiliation></affiliation></author><author><name sortKey="Barrientos, Jacqueline C" sort="Barrientos, Jacqueline C" uniqKey="Barrientos J" first="Jacqueline C" last="Barrientos">Jacqueline C. Barrientos</name><affiliation><nlm:affiliation>Hofstra Northwell School of Medicine, Hofstra University, New Hyde Park, NY, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Brown, Jennifer R" sort="Brown, Jennifer R" uniqKey="Brown J" first="Jennifer R" last="Brown">Jennifer R. Brown</name><affiliation><nlm:affiliation>Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Coiffier, Bertrand" sort="Coiffier, Bertrand" uniqKey="Coiffier B" first="Bertrand" last="Coiffier">Bertrand Coiffier</name><affiliation><nlm:affiliation>Department of Haematology, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.</nlm:affiliation></affiliation></author><author><name sortKey="Delgado, Julio" sort="Delgado, Julio" uniqKey="Delgado J" first="Julio" last="Delgado">Julio Delgado</name><affiliation><nlm:affiliation>Department of Haematology, Hospital Clínic, Barcelona, Spain.</nlm:affiliation></affiliation></author><author><name sortKey="Egyed, Mikl S" sort="Egyed, Mikl S" uniqKey="Egyed M" first="Mikl S" last="Egyed">Mikl S Egyed</name><affiliation><nlm:affiliation>Department of Haematology, Somogy County Kaposi Mór Hospital, Kaposvar, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Ghia, Paolo" sort="Ghia, Paolo" uniqKey="Ghia P" first="Paolo" last="Ghia">Paolo Ghia</name><affiliation><nlm:affiliation>Division of Experimental Oncology and Department of Onco-Haematology, IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Illes, Arpad" sort="Illes, Arpad" uniqKey="Illes A" first="Árpád" last="Illés">Árpád Illés</name><affiliation><nlm:affiliation>Department of Haematology, University of Debrecen, Debrecen, Hungary.</nlm:affiliation></affiliation></author><author><name sortKey="Jurczak, Wojciech" sort="Jurczak, Wojciech" uniqKey="Jurczak W" first="Wojciech" last="Jurczak">Wojciech Jurczak</name><affiliation><nlm:affiliation>Department of Haematology, Jagiellonian University, Krakow, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Marlton, Paula" sort="Marlton, Paula" uniqKey="Marlton P" first="Paula" last="Marlton">Paula Marlton</name><affiliation><nlm:affiliation>Department of Haematology, Princess Alexandra Hospital, University of Queensland, School of Medicine, Brisbane, Australia.</nlm:affiliation></affiliation></author><author><name sortKey="Montillo, Marco" sort="Montillo, Marco" uniqKey="Montillo M" first="Marco" last="Montillo">Marco Montillo</name><affiliation><nlm:affiliation>Department of Haematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.</nlm:affiliation></affiliation></author><author><name sortKey="Morschhauser, Franck" sort="Morschhauser, Franck" uniqKey="Morschhauser F" first="Franck" last="Morschhauser">Franck Morschhauser</name><affiliation><nlm:affiliation>CHRU Lille, Unité GRITA, Department of Haematology, Université de Lille, Lille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Pristupa, Alexander S" sort="Pristupa, Alexander S" uniqKey="Pristupa A" first="Alexander S" last="Pristupa">Alexander S. Pristupa</name><affiliation><nlm:affiliation>Department of Haematology, Ryazan Regional Clinical Hospital, Ryazan, Russia.</nlm:affiliation></affiliation></author><author><name sortKey="Robak, Tadeusz" sort="Robak, Tadeusz" uniqKey="Robak T" first="Tadeusz" last="Robak">Tadeusz Robak</name><affiliation><nlm:affiliation>Department of Haematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland.</nlm:affiliation></affiliation></author><author><name sortKey="Sharman, Jeff P" sort="Sharman, Jeff P" uniqKey="Sharman J" first="Jeff P" last="Sharman">Jeff P. Sharman</name><affiliation><nlm:affiliation>US Oncology Research, Willamette Valley Cancer Institute and Research Center, Eugene, OR, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Simpson, David" sort="Simpson, David" uniqKey="Simpson D" first="David" last="Simpson">David Simpson</name><affiliation><nlm:affiliation>North Shore Hospital, Takapuna, Auckland, New Zealand.</nlm:affiliation></affiliation></author><author><name sortKey="Smolej, Lukas" sort="Smolej, Lukas" uniqKey="Smolej L" first="Lukáš" last="Smolej">Lukáš Smolej</name><affiliation><nlm:affiliation>4th Department of Internal Medicine-Haematology, University Hospital and Charles University in Prague, Faculty of Medicine in Hradec Králové, Hradec Králové, Czech Republic.</nlm:affiliation></affiliation></author><author><name sortKey="Tausch, Eugen" sort="Tausch, Eugen" uniqKey="Tausch E" first="Eugen" last="Tausch">Eugen Tausch</name><affiliation><nlm:affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Adewoye, Adeboye H" sort="Adewoye, Adeboye H" uniqKey="Adewoye A" first="Adeboye H" last="Adewoye">Adeboye H. Adewoye</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Dreiling, Lyndah K" sort="Dreiling, Lyndah K" uniqKey="Dreiling L" first="Lyndah K" last="Dreiling">Lyndah K. Dreiling</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Kim, Yeonhee" sort="Kim, Yeonhee" uniqKey="Kim Y" first="Yeonhee" last="Kim">Yeonhee Kim</name><affiliation><nlm:affiliation>Gilead Sciences, Foster City, CA, USA.</nlm:affiliation></affiliation></author><author><name sortKey="Stilgenbauer, Stephan" sort="Stilgenbauer, Stephan" uniqKey="Stilgenbauer S" first="Stephan" last="Stilgenbauer">Stephan Stilgenbauer</name><affiliation><nlm:affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</nlm:affiliation></affiliation></author><author><name sortKey="Hillmen, Peter" sort="Hillmen, Peter" uniqKey="Hillmen P" first="Peter" last="Hillmen">Peter Hillmen</name><affiliation><nlm:affiliation>Department of Haematology/Oncology, St James's University Hospital, Leeds, UK.</nlm:affiliation></affiliation></author></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2017" type="published">2017</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><term>Aged</term><term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term><term>Bendamustine Hydrochloride (administration & dosage)</term><term>Double-Blind Method</term><term>Drug Resistance, Neoplasm (drug effects)</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy)</term><term>Leukemia, Lymphocytic, Chronic, B-Cell (pathology)</term><term>Male</term><term>Middle Aged</term><term>Neoplasm Recurrence, Local (drug therapy)</term><term>Neoplasm Recurrence, Local (pathology)</term><term>Neoplasm Staging</term><term>Prognosis</term><term>Purines (administration & dosage)</term><term>Quinazolinones (administration & dosage)</term><term>Rituximab (administration & dosage)</term><term>Salvage Therapy</term><term>Survival Rate</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Bendamustine Hydrochloride</term><term>Purines</term><term>Quinazolinones</term><term>Rituximab</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Drug Resistance, Neoplasm</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Leukemia, Lymphocytic, Chronic, B-Cell</term><term>Neoplasm Recurrence, Local</term></keywords><keywords scheme="MESH" qualifier="pathology" xml:lang="en"><term>Leukemia, Lymphocytic, Chronic, B-Cell</term><term>Neoplasm Recurrence, Local</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Double-Blind Method</term><term>Female</term><term>Follow-Up Studies</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Neoplasm Staging</term><term>Prognosis</term><term>Salvage Therapy</term><term>Survival Rate</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Bendamustine plus rituximab is a standard of care for the management of patients with relapsed or refractory chronic lymphocytic leukaemia. New therapies are needed to improve clinically relevant outcomes in these patients. We assessed the efficacy and safety of adding idelalisib, a first-in-class targeted phosphoinositide-3-kinase δ inhibitor, to bendamustine plus rituximab in this population.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">28139405</PMID><DateCreated><Year>2017</Year><Month>01</Month><Day>31</Day></DateCreated><DateCompleted><Year>2017</Year><Month>06</Month><Day>08</Day></DateCompleted><DateRevised><Year>2017</Year><Month>09</Month><Day>08</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN><JournalIssue CitedMedium="Internet"><Volume>18</Volume><Issue>3</Issue><PubDate><Year>2017</Year><Month>Mar</Month></PubDate></JournalIssue><Title>The Lancet. Oncology</Title><ISOAbbreviation>Lancet Oncol.</ISOAbbreviation></Journal><ArticleTitle>Idelalisib or placebo in combination with bendamustine and rituximab in patients with relapsed or refractory chronic lymphocytic leukaemia: interim results from a phase 3, randomised, double-blind, placebo-controlled trial.</ArticleTitle><Pagination><MedlinePgn>297-311</MedlinePgn></Pagination><ELocationID EIdType="pii" ValidYN="Y">S1470-2045(16)30671-4</ELocationID><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(16)30671-4</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Bendamustine plus rituximab is a standard of care for the management of patients with relapsed or refractory chronic lymphocytic leukaemia. New therapies are needed to improve clinically relevant outcomes in these patients. We assessed the efficacy and safety of adding idelalisib, a first-in-class targeted phosphoinositide-3-kinase δ inhibitor, to bendamustine plus rituximab in this population.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">For this international, multicentre, double-blind, placebo-controlled trial, adult patients (≥18 years) with relapsed or refractory chronic lymphocytic leukaemia requiring treatment who had measurable lymphadenopathy by CT or MRI and disease progression within 36 months since their last previous therapy were enrolled. Patients were randomly assigned (1:1) by a central interactive web response system to receive bendamustine plus rituximab for a maximum of six cycles (bendamustine: 70 mg/m(2) intravenously on days 1 and 2 for six 28-day cycles; rituximab: 375 mg/m(2) on day 1 of cycle 1, and 500 mg/m(2) on day 1 of cycles 2-6) in addition to either twice-daily oral idelalisib (150 mg) or placebo until disease progression or intolerable study drug-related toxicity. Randomisation was stratified by high-risk features (IGHV, del[17p], or TP53 mutation) and refractory versus relapsed disease. The primary endpoint was progression-free survival assessed by an independent review committee in the intention-to-treat population. This trial is ongoing and is registered with ClinicalTrials.gov, number NCT01569295.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between June 26, 2012, and Aug 21, 2014, 416 patients were enrolled and randomly assigned to the idelalisib (n=207) and placebo (n=209) groups. At a median follow-up of 14 months (IQR 7-18), median progression-free survival was 20·8 months (95% CI 16·6-26·4) in the idelalisib group and 11·1 months (8·9-11·1) in the placebo group (hazard ratio [HR] 0·33, 95% CI 0·25-0·44; p<0·0001). The most frequent grade 3 or worse adverse events in the idelalisib group were neutropenia (124 [60%] of 207 patients) and febrile neutropenia (48 [23%]), whereas in the placebo group they were neutropenia (99 [47%] of 209) and thrombocytopenia (27 [13%]). An increased risk of infection was reported in the idelalisib group compared with the placebo group (grade ≥3 infections and infestations: 80 [39%] of 207 vs 52 [25%] of 209). Serious adverse events, including febrile neutropenia, pneumonia, and pyrexia, were more common in the idelalisib group (140 [68%] of 207 patients) than in the placebo group (92 [44%] of 209). Treatment-emergent adverse events leading to death occurred in 23 (11%) patients in the idelalisib group and 15 (7%) in the placebo group, including six deaths from infections in the idelalisib group and three from infections in the placebo group.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Idelalisib in combination with bendamustine plus rituximab improved progression-free survival compared with bendamustine plus rituximab alone in patients with relapsed or refractory chronic lymphocytic leukaemia. However, careful attention needs to be paid to management of serious adverse events and infections associated with this regimen during treatment selection.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Gilead Sciences Inc.</AbstractText><CopyrightInformation>Copyright © 2017 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Zelenetz</LastName><ForeName>Andrew D</ForeName><Initials>AD</Initials><AffiliationInfo><Affiliation>Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: zeleneta@mskcc.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barrientos</LastName><ForeName>Jacqueline C</ForeName><Initials>JC</Initials><AffiliationInfo><Affiliation>Hofstra Northwell School of Medicine, Hofstra University, New Hyde Park, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brown</LastName><ForeName>Jennifer R</ForeName><Initials>JR</Initials><AffiliationInfo><Affiliation>Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Coiffier</LastName><ForeName>Bertrand</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>Department of Haematology, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Delgado</LastName><ForeName>Julio</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Department of Haematology, Hospital Clínic, Barcelona, Spain.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Egyed</LastName><ForeName>Miklós</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Haematology, Somogy County Kaposi Mór Hospital, Kaposvar, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ghia</LastName><ForeName>Paolo</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Division of Experimental Oncology and Department of Onco-Haematology, IRCCS Ospedale San Raffaele and Università Vita-Salute San Raffaele, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Illés</LastName><ForeName>Árpád</ForeName><Initials>Á</Initials><AffiliationInfo><Affiliation>Department of Haematology, University of Debrecen, Debrecen, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jurczak</LastName><ForeName>Wojciech</ForeName><Initials>W</Initials><AffiliationInfo><Affiliation>Department of Haematology, Jagiellonian University, Krakow, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Marlton</LastName><ForeName>Paula</ForeName><Initials>P</Initials><AffiliationInfo><Affiliation>Department of Haematology, Princess Alexandra Hospital, University of Queensland, School of Medicine, Brisbane, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Montillo</LastName><ForeName>Marco</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Department of Haematology, Niguarda Cancer Center, Niguarda Hospital, Milan, Italy.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Morschhauser</LastName><ForeName>Franck</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>CHRU Lille, Unité GRITA, Department of Haematology, Université de Lille, Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Pristupa</LastName><ForeName>Alexander S</ForeName><Initials>AS</Initials><AffiliationInfo><Affiliation>Department of Haematology, Ryazan Regional Clinical Hospital, Ryazan, Russia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Robak</LastName><ForeName>Tadeusz</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Department of Haematology, Medical University of Lodz and Copernicus Memorial Hospital, Lodz, Poland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sharman</LastName><ForeName>Jeff P</ForeName><Initials>JP</Initials><AffiliationInfo><Affiliation>US Oncology Research, Willamette Valley Cancer Institute and Research Center, Eugene, OR, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Simpson</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>North Shore Hospital, Takapuna, Auckland, New Zealand.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Smolej</LastName><ForeName>Lukáš</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>4th Department of Internal Medicine-Haematology, University Hospital and Charles University in Prague, Faculty of Medicine in Hradec Králové, Hradec Králové, Czech Republic.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Tausch</LastName><ForeName>Eugen</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>Department of Internal Medicine III, Ulm University, Ulm, Germany.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Adewoye</LastName><ForeName>Adeboye H</ForeName><Initials>AH</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dreiling</LastName><ForeName>Lyndah K</ForeName><Initials>LK</Initials><AffiliationInfo><Affiliation>Gilead Sciences, Foster City, CA, 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Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2017</Year><Month>01</Month><Day>28</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Oncol</MedlineTA><NlmUniqueID>100957246</NlmUniqueID><ISSNLinking>1470-2045</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D011687">Purines</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D052999">Quinazolinones</NameOfSubstance></Chemical><Chemical><RegistryNumber>4F4X42SYQ6</RegistryNumber><NameOfSubstance UI="D000069283">Rituximab</NameOfSubstance></Chemical><Chemical><RegistryNumber>981Y8SX18M</RegistryNumber><NameOfSubstance 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dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D052999" MajorTopicYN="N">Quinazolinones</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000069283" MajorTopicYN="N">Rituximab</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D016879" MajorTopicYN="Y">Salvage Therapy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D015996" MajorTopicYN="N">Survival Rate</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2016</Year><Month>07</Month><Day>19</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2016</Year><Month>10</Month><Day>11</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2016</Year><Month>10</Month><Day>14</Day></PubMedPubDate><PubMedPubDate 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