{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,8]],"date-time":"2026-09-08T04:55:16Z","timestamp":1788843316466,"version":"build-2803163510"},"reference-count":24,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T00:00:00Z","timestamp":1766361600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2025,12,22]],"date-time":"2025-12-22T00:00:00Z","timestamp":1766361600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100020193","name":"Novartis Australia","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100020193","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100020537","name":"Merck Sharp and Dohme Australia","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100020537","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Br J Haematol"],"published-print":{"date-parts":[[2026,2]]},"abstract":"<jats:title>Summary<\/jats:title>\n                  <jats:p>\n                    We evaluated the tolerability and efficacy of pegylated interferon alfa\u20102B (peg\u2010IFN\u03b1; PegIntron, MSD) combined with nilotinib in the Australasian Leukaemia and Lymphoma Group CML11 (Pinnacle) study. This phase II study started patients on nilotinib 300\u2009mg twice daily. Subcutaneous peg\u2010IFN\u03b1 was added at 30\u201350 50\u2009\u03bcg\/week from 3\u2009months until 24\u2009months as tolerated. Sixty patients were enrolled with a median age of 48.5\u2009years (range 19\u201372); 45% were female. With a median follow\u2010up of 60\u2009months, 40 patients (67%) remain on study. The proportion of patients who received \u226550% and \u226585% of their assigned peg\u2010IFN\u03b1 doses were 58% and 35% respectively. Common reasons for peg\u2010IFN\u03b1 discontinuation were mood disturbance (5), thyroid disease (4) and myalgia (4). The cumulative incidence of Major Molecular Response\u00a0(MMR,\n                    <jats:italic>BCR::ABL1<\/jats:italic>\n                    \u22640.1%) was 87% by 12\u2009months; Molecular Response 4.5 (MR4.5,\n                    <jats:italic>BCR::ABL1<\/jats:italic>\n                    \u22640.0032%) incidence at 24 and 60\u2009months was 55% and 82% respectively. Thirty\u2010seven patients (62%) had MR4.5 for &gt;24\u2009months, 14 of whom attempted treatment\u2010free remission (TFR); 13 remained in TFR at a median follow\u2010up of 32\u2009months. CML11 demonstrated that peg\u2010IFN\u03b1 with nilotinib leads to high rates of molecular response, with tolerability similar to prior studies. Trial registration ANZCTRN12612000851864.\n                  <\/jats:p>","DOI":"10.1111\/bjh.70276","type":"journal-article","created":{"date-parts":[[2025,12,23]],"date-time":"2025-12-23T07:46:01Z","timestamp":1766475961000},"page":"599-607","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["The\n                    <scp>PINNACLE<\/scp>\n                    study: A multicentre phase\n                    <scp>II<\/scp>\n                    trial of nilotinib in combination with pegylated interferon\u2010\u03b12b in newly diagnosed chronic phase chronic myeloid leukaemia"],"prefix":"10.1111","volume":"208","author":[{"given":"David T.","family":"Yeung","sequence":"first","affiliation":[{"name":"Department of Haematology Royal Adelaide Hospital  Adelaide South Australia Australia"},{"name":"South Australian Health &amp; Medical Research Institute &amp; University of Adelaide  Adelaide South Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew P.","family":"Grigg","sequence":"additional","affiliation":[{"name":"Department of Haematology Austin Health &amp; University of Melbourne  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Reynolds","sequence":"additional","affiliation":[{"name":"Department of Haematology, the Alfred Hospital and Department of Biostatistics Monash University  Clayton Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Branford","sequence":"additional","affiliation":[{"name":"Genetics &amp; Molecular Pathology, SA Pathology &amp; Centre for Cancer Biology University of South Australia  Adelaide South Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Deepmala","family":"Mazumdar","sequence":"additional","affiliation":[{"name":"Australasian Leukaemia &amp; Lymphoma Group  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilona","family":"Cunningham","sequence":"additional","affiliation":[{"name":"Department of Haematology Concord Hospital &amp; University of Sydney  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jake","family":"Shortt","sequence":"additional","affiliation":[{"name":"Department of Haematology Monash Medical Centre &amp; Monash Medical Centre  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Rowlings","sequence":"additional","affiliation":[{"name":"Department of Haematology Calvary Mater Hospital and University of Newcastle  Newcastle New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9770-2791","authenticated-orcid":false,"given":"Rosemary","family":"Harrup","sequence":"additional","affiliation":[{"name":"Department of Haematology Royal Hobart Hospital &amp; University of Tasmania  Hobart Tasmania Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M.","family":"Ross","sequence":"additional","affiliation":[{"name":"Genetics &amp; Molecular Pathology, SA Pathology &amp; Centre for Cancer Biology University of South Australia  Adelaide South Australia Australia"},{"name":"Department of Haematology Flinders Medical Centre &amp; Flinders University  Adelaide South Australia Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Kipp","sequence":"additional","affiliation":[{"name":"Department of Haematology University Hospital Geelong (Barwon Health) &amp; Deakin University  Geelong Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony K.","family":"Mills","sequence":"additional","affiliation":[{"name":"Department of Haematology Princess Alexandra Hospital &amp; University of Queensland  Brisbane Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher K.","family":"Arthur","sequence":"additional","affiliation":[{"name":"Department of Haematology Royal North Shore Hospital &amp; University of Sydney  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Schwarer","sequence":"additional","affiliation":[{"name":"Department of Haematology Box Hill Hospital &amp; Monash University  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kathryn","family":"Jackson","sequence":"additional","affiliation":[{"name":"Department of Haematology Sunshine Coast University Hospital  Birtinya Queensland Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Viiala","sequence":"additional","affiliation":[{"name":"Department of Haematology Liverpool Hospital &amp; University of New South Wales  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert","family":"Weinkove","sequence":"additional","affiliation":[{"name":"Department of Haematology Te Rerenga Ora Blood &amp; Cancer Centre &amp; Malaghan Institute of Medical Research  Wellington New Zealand"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnes S. 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