{"id":"https://openalex.org/W4361815422","doi":"https://doi.org/10.1158/1078-0432.c.6530352.v1","title":"Data from Efficacy and Safety of Duvelisib Following Disease Progression on Ofatumumab in Patients with Relapsed/Refractory CLL or SLL in the DUO Crossover Extension Study","display_name":"Data from Efficacy and Safety of Duvelisib Following Disease Progression on Ofatumumab in Patients with Relapsed/Refractory CLL or SLL in the DUO Crossover Extension Study","publication_year":2023,"publication_date":"2023-03-31","ids":{"openalex":"https://openalex.org/W4361815422","doi":"https://doi.org/10.1158/1078-0432.c.6530352.v1"},"language":"en","primary_location":{"id":"doi:10.1158/1078-0432.c.6530352.v1","doi":"https://doi.org/10.1158/1078-0432.c.6530352.v1","is_oa":true,"landing_page_url":"https://doi.org/10.1158/1078-0432.c.6530352.v1","pdf_url":null,"source":null,"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"American Association for Cancer Research","raw_type":"posted-content"},"volume":null,"type":"other","is_traditional":false,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://doi.org/10.1158/1078-0432.c.6530352.v1","any_repository_has_fulltext":null},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5063755644","display_name":"Matthew Steven Davids","orcid":"https://orcid.org/0000-0003-4529-2003","observed_orcids":["https://orcid.org/0000-0003-4529-2003"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Matthew S. Davids","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5002467749","display_name":"Bryone Jean Kuss","orcid":"https://orcid.org/0000-0002-5811-1331","observed_orcids":["https://orcid.org/0000-0002-5811-1331"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Bryone J. Kuss","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5047631289","display_name":"Peter Hillmen","orcid":"https://orcid.org/0000-0001-5617-4403","observed_orcids":["https://orcid.org/0000-0001-5617-4403"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Peter Hillmen","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0001-5617-4403","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5039819830","display_name":"Marco Montillo","orcid":"https://orcid.org/0000-0003-0010-032X","observed_orcids":["https://orcid.org/0000-0003-0010-032X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Marco Montillo","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5056554686","display_name":"Carol Moreno","orcid":"https://orcid.org/0000-0003-3275-0271","observed_orcids":["https://orcid.org/0000-0003-3275-0271"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Carol Moreno","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5044422916","display_name":"James H. Essell","orcid":"https://orcid.org/0000-0002-9173-0310","observed_orcids":["https://orcid.org/0000-0002-9173-0310"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"James Essell","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5010100538","display_name":"Nicole Lamanna","orcid":"https://orcid.org/0000-0003-3331-9491","observed_orcids":["https://orcid.org/0000-0003-3331-9491"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Nicole Lamanna","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":null,"display_name":"Zsolt Nagy","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Zsolt Nagy","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5034517642","display_name":"Constantine Si Lun Tam","orcid":"https://orcid.org/0000-0002-9759-5017","observed_orcids":["https://orcid.org/0000-0002-9759-5017"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Constantine S. Tam","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5019866348","display_name":"Stephan Stilgenbauer","orcid":"https://orcid.org/0000-0002-6830-9296","observed_orcids":["https://orcid.org/0000-0002-6830-9296"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Stephan Stilgenbauer","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5087770514","display_name":"Paolo Ghia","orcid":"https://orcid.org/0000-0003-3750-7342","observed_orcids":["https://orcid.org/0000-0003-3750-7342"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Paolo Ghia","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0003-3750-7342","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5014405902","display_name":"Julio Delgado","orcid":"https://orcid.org/0000-0002-5157-4376","observed_orcids":["https://orcid.org/0000-0002-5157-4376"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Julio Delgado","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5006302059","display_name":"Stephanie Lustgarten","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Stephanie Lustgarten","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5074838425","display_name":"David T. Weaver","orcid":"https://orcid.org/0000-0001-8398-3919","observed_orcids":["https://orcid.org/0000-0001-8398-3919"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"David T. Weaver","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5065694446","display_name":"Hagop Youssoufian","orcid":"https://orcid.org/0009-0003-1673-8384","observed_orcids":["https://orcid.org/0009-0003-1673-8384"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Hagop Youssoufian","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5113865605","display_name":"Ulrich Jaeger","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ulrich J\u00e4ger","raw_affiliation_strings":[],"raw_orcid":null,"affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11157","display_name":"Chronic Lymphocytic Leukemia Research","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11157","display_name":"Chronic Lymphocytic Leukemia Research","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10185","display_name":"Lymphoma Diagnosis and Treatment","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2734","display_name":"Pathology and Forensic Medicine"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10950","display_name":"Acute Lymphoblastic Leukemia research","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/duvelisib","display_name":"duvelisib","score":0.996999979019165},{"id":"https://openalex.org/keywords/ofatumumab","display_name":"ofatumumab","score":0.9850000143051147},{"id":"https://openalex.org/keywords/relapsed-refractory-chronic-lymphocytic-leukemia","display_name":"relapsed/refractory chronic lymphocytic leukemia","score":0.9660000205039978},{"id":"https://openalex.org/keywords/small-lymphocytic-lymphoma","display_name":"small lymphocytic lymphoma","score":0.9940000176429749},{"id":"https://openalex.org/keywords/disease-progression","display_name":"disease progression","score":0.6320000290870667},{"id":"https://openalex.org/keywords/progression-free-survival","display_name":"progression-free survival","score":0.8180000185966492},{"id":"https://openalex.org/keywords/overall-response-rate","display_name":"overall response rate","score":0.9409999847412109},{"id":"https://openalex.org/keywords/duration-of-response","display_name":"duration of response","score":0.7570000290870667},{"id":"https://openalex.org/keywords/17p-deletion","display_name":"17p deletion","score":0.8130000233650208},{"id":"https://openalex.org/keywords/tp53-mutation","display_name":"TP53 mutation","score":0.9599999785423279},{"id":"https://openalex.org/keywords/diarrhea","display_name":"diarrhea","score":0.6169999837875366},{"id":"https://openalex.org/keywords/neutropenia","display_name":"neutropenia","score":0.9750000238418579},{"id":"https://openalex.org/keywords/thrombocytopenia","display_name":"thrombocytopenia","score":0.847000002861023},{"id":"https://openalex.org/keywords/treatment-emergent-adverse-events","display_name":"treatment-emergent adverse events","score":0.7419999837875366}],"concepts":[{"id":"https://openalex.org/C2778714382","wikidata":"https://www.wikidata.org/wiki/Q410656","display_name":"Ofatumumab","level":4,"score":0.9297627210617065},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7851920127868652},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.6879486441612244},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.6421929597854614},{"id":"https://openalex.org/C142424586","wikidata":"https://www.wikidata.org/wiki/Q7307572","display_name":"Refractory (planetary science)","level":2,"score":0.574157178401947},{"id":"https://openalex.org/C203092338","wikidata":"https://www.wikidata.org/wiki/Q1340863","display_name":"Clinical endpoint","level":3,"score":0.5718359351158142},{"id":"https://openalex.org/C2777938653","wikidata":"https://www.wikidata.org/wiki/Q1088156","display_name":"Chronic lymphocytic leukemia","level":3,"score":0.5114532709121704},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.4721387028694153},{"id":"https://openalex.org/C2780739268","wikidata":"https://www.wikidata.org/wiki/Q2112244","display_name":"Progression-free survival","level":3,"score":0.4108359217643738},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.3240496516227722},{"id":"https://openalex.org/C2778461978","wikidata":"https://www.wikidata.org/wiki/Q29496","display_name":"Leukemia","level":2,"score":0.2652566432952881},{"id":"https://openalex.org/C3019894029","wikidata":"https://www.wikidata.org/wiki/Q332823","display_name":"Overall survival","level":2,"score":0.19280269742012024},{"id":"https://openalex.org/C87355193","wikidata":"https://www.wikidata.org/wiki/Q411","display_name":"Astrobiology","level":1,"score":0.0},{"id":"https://openalex.org/C121332964","wikidata":"https://www.wikidata.org/wiki/Q413","display_name":"Physics","level":0,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1158/1078-0432.c.6530352.v1","doi":"https://doi.org/10.1158/1078-0432.c.6530352.v1","is_oa":true,"landing_page_url":"https://doi.org/10.1158/1078-0432.c.6530352.v1","pdf_url":null,"source":null,"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"American Association for Cancer Research","raw_type":"posted-content"}],"best_oa_location":{"id":"doi:10.1158/1078-0432.c.6530352.v1","doi":"https://doi.org/10.1158/1078-0432.c.6530352.v1","is_oa":true,"landing_page_url":"https://doi.org/10.1158/1078-0432.c.6530352.v1","pdf_url":null,"source":null,"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"acceptedVersion","is_accepted":true,"is_published":false,"raw_source_name":"American Association for Cancer Research","raw_type":"posted-content"},"sustainable_development_goals":[{"score":0.9940000176429749,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W3001171775","https://openalex.org/W2891876928","https://openalex.org/W2905375175","https://openalex.org/W2895287765","https://openalex.org/W2784823232","https://openalex.org/W2951349998","https://openalex.org/W2971027550","https://openalex.org/W2988180727","https://openalex.org/W4390273649","https://openalex.org/W7047470861"],"abstract_inverted_index":{"AbstractPurpose:":[0],"In":[1],"the":[2,77,133],"phase":[3],"III":[4],"DUO":[5,78,134],"trial,":[6],"duvelisib,":[7],"an":[8,140,163],"oral":[9],"dual":[10],"PI3K-\u03b4,\u03b3":[11],"inhibitor,":[12],"demonstrated":[13,225],"significantly":[14],"improved":[15],"efficacy":[16],"versus":[17],"ofatumumab":[18,70,89,198],"[median":[19],"(m)":[20],"progression-free":[21],"survival":[22],"(PFS),":[23],"13.3":[24],"vs.":[25,38],"9.9":[26],"months":[27,167],"(HR,":[28],"0.52;":[29],"P":[30],"<":[31,41],"0.0001);":[32],"overall":[33],"response":[34,118,227],"rate":[35],"[ORR],":[36],"74%":[37],"45%":[39],"(P":[40],"0.0001)],":[42],"with":[43,50,65,84,162,174,193,229,239,248],"a":[44,160,200,233],"manageable":[45,234],"safety":[46,235],"profile":[47,236],"in":[48,76,96,132,237],"patients":[49,64,131,157,191,238,247],"relapsed/refractory":[51],"(R/R)":[52],"chronic":[53],"lymphocytic":[54,57],"leukemia":[55],"(CLL)/small":[56],"lymphoma":[58],"(SLL).":[59],"We":[60],"report":[61],"results":[62],"from":[63],"progressive":[66],"disease":[67,194,250,252],"(PD)":[68],"after":[69,88],"who":[71,242],"crossed":[72],"over":[73],"to":[74,137,197,255],"duvelisib":[75,91],"trial.":[79],"Patients":[80,83,173],"and":[81,121,148,168,220,232,251],"Methods:":[82],"radiographically":[85],"confirmed":[86],"PD":[87],"received":[90],"25":[92],"mg":[93],"twice":[94],"daily":[95],"28-day":[97],"cycles":[98],"until":[99],"PD,":[100],"intolerance,":[101],"death,":[102],"or":[103],"study":[104],"withdrawal.":[105],"The":[106,202],"primary":[107],"endpoint":[108],"was":[109],"ORR":[110,141],"per":[111],"investigator.":[112],"Secondary":[113],"endpoints":[114],"included":[115],"duration":[116],"of":[117,125,142,145,150,156,165,170,190],"(DOR),":[119],"PFS,":[120],"safety.":[122],"Results:":[123],"As":[124],"December":[126],"14,":[127],"2018,":[128],"90":[129],"ofatumumab-treated":[130],"trial":[135],"prior":[136],"crossover":[138],"had":[139,179],"29%,":[143],"mDOR":[144,164],"10.4":[146],"months,":[147],"mPFS":[149,169],"9.4":[151],"months.":[152,172],"After":[153],"crossover,":[154],"77%":[155,183],"(69/90)":[158],"achieved":[159,199],"response,":[161],"14.9":[166],"15.7":[171],"del(17p)":[175],"and/or":[176],"TP53":[177],"mutations":[178],"similar":[180],"outcomes":[181],"[ORR,":[182],"(20/26);":[184],"mPFS,":[185],"14.7":[186],"months].":[187],"Notably,":[188],"73%":[189],"(47/64)":[192],"previously":[195,253],"refractory":[196,254],"response.":[201],"most":[203],"frequent":[204],"any-grade/grade":[205],"3/4":[206],"treatment-emergent":[207],"adverse":[208],"events":[209],"were":[210],"diarrhea":[211],"(47%/23%),":[212],"neutropenia":[213],"(26%/23%),":[214],"pyrexia":[215],"(24%/4%),":[216],"cutaneous":[217],"reactions":[218],"(23%/4%),":[219],"thrombocytopenia":[221],"(10%/6%).":[222],"Conclusions:":[223],"Duvelisib":[224],"high":[226],"rates":[228],"good":[230],"durability":[231],"R/R":[240],"CLL/SLL":[241],"progressed":[243],"on":[244],"ofatumumab,":[245],"including":[246],"high-risk":[249],"ofatumumab.":[256]},"counts_by_year":[],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2023-04-05T00:00:00"}