{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,27]],"date-time":"2026-05-27T13:24:04Z","timestamp":1779888244804,"version":"3.53.1"},"reference-count":29,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T00:00:00Z","timestamp":1761782400000},"content-version":"vor","delay-in-days":29,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["HemaSphere"],"published-print":{"date-parts":[[2025,10]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    Children with relapsed acute leukemia have a poor prognosis; current relapse treatments are toxic, and novel treatments are needed. The anti\u2010CD38 antibody isatuximab is approved for relapsed\u2010refractory multiple myeloma in adults. We present results of the ISAKIDS study (NCT03860844) investigating isatuximab in children with relapsed\u2010refractory acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML). This Phase 2, single\u2010arm, multicenter, open\u2010label study enrolled children aged 28 days to &lt;18 years. Patients received isatuximab 20\u2009mg\/kg induction on Day 1, then weekly for 5 weeks (ALL) or 3 weeks (AML). Standard salvage chemotherapy was added on Day 8. Participants showing possible response could receive consolidation with every\u2010other\u2010week isatuximab (two doses) plus chemotherapy (T\u2010ALL, B\u2010ALL) or optional second induction (AML). The primary endpoint was the complete response (CR) rate (proportion with CR or CR with incomplete peripheral recovery [CRi]). CR\/CRi was observed for 32\/59 (54%) evaluable patients (B\u2010ALL, 13\/25 [52%]; T\u2010ALL, 5\/11 [45%]; and AML, 14\/23 [61%]). Secondary endpoints included minimal residual disease (MRD) status and safety. Based on local and central analysis, 56% (18\/32) of CR\/CRi patients reached MRD negativity using 10\n                    <jats:sup>\u22124<\/jats:sup>\n                    sensitivity threshold for ALL and 10\n                    <jats:sup>\u22123<\/jats:sup>\n                    sensitivity threshold for AML. One event of fatal cytokine release syndrome was reported in a patient with a high baseline white blood cell count, leading to trial adaptation. The toxicity of isatuximab with chemotherapy was otherwise manageable. Despite initial evidence of efficacy of isatuximab combined with intensive chemotherapy, CR\/CRi rates did not meet stringent prespecified criteria to proceed to ISAKIDS Stage 2 (\u226560% [T\u2010ALL] and \u226570% [B\u2010ALL and AML]).\n                  <\/jats:p>","DOI":"10.1002\/hem3.70245","type":"journal-article","created":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T09:54:27Z","timestamp":1761818067000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Isatuximab in combination with chemotherapy for pediatric patients with relapsed\/refractory acute lymphoblastic leukemia or acute myeloid leukemia: The ISAKIDS study"],"prefix":"10.1002","volume":"9","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-0120-6089","authenticated-orcid":false,"given":"Andr\u00e9","family":"Baruchel","sequence":"first","affiliation":[{"name":"Robert Debr\u00e9 University Hospital (APHP and Universit\u00e9 Paris Cit\u00e9) Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2935-0058","authenticated-orcid":false,"given":"Karsten","family":"Nysom","sequence":"additional","affiliation":[{"name":"Department of Paediatrics &amp; Adolescent Medicine Copenhagen University Hospital\u2013Rigshospitalet Copenhagen Denmark"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1009-6002","authenticated-orcid":false,"given":"Hyoung Jin","family":"Kang","sequence":"additional","affiliation":[{"name":"Department of Pediatrics Seoul National University Cancer Research Institute, Wide River Institute of Immunology, Seoul National University College of Medicine, Seoul National University Children's Hospital Seoul Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7505-6549","authenticated-orcid":false,"given":"Maria S.","family":"Felice","sequence":"additional","affiliation":[{"name":"Hematology and Oncology Department Hospital de Pediatr\u00eda Prof. Dr. Juan P. Garrahan Buenos Aires Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9482-0776","authenticated-orcid":false,"given":"Mariana Bohns","family":"Michalowski","sequence":"additional","affiliation":[{"name":"Hospital de Cl\u00ednicas de Porto Alegre, Unidade de Pesquisa em Hematologia Porto Alegre Rio Grande do Sul Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Freigeiro","sequence":"additional","affiliation":[{"name":"Hospital de Ni\u00f1os Ricardo Gutierrez Capital Federal Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6656-2992","authenticated-orcid":false,"given":"Sidnei","family":"Epelman","sequence":"additional","affiliation":[{"name":"Hospital Santa Marcelina S\u00e3o Paulo S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8479-6322","authenticated-orcid":false,"given":"Ana Virginia","family":"Lopes de Sousa","sequence":"additional","affiliation":[{"name":"Grupo de Apoio \u00e0 Crian\u00e7a e ao Adolescente com C\u00e2ncer\u2013GRAACC\/UNIFESP S\u00e3o Paulo S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4434-429X","authenticated-orcid":false,"given":"Elvis Terci","family":"Valera","sequence":"additional","affiliation":[{"name":"Unidade de Pesquisa Cl\u00ednica do HC FMRP\u2013USP, Hospital da Cl\u00ednicas Ribeir\u00e3o Preto Ribeir\u00e3o Preto S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Larissa","family":"Moreira","sequence":"additional","affiliation":[{"name":"Fundacao Dr Amaral Carvalho\u2010Hospital Dr Amaral Carvalho Jau S\u00e3o Paulo Brazil"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4157-0793","authenticated-orcid":false,"given":"Guy","family":"Leverger","sequence":"additional","affiliation":[{"name":"INSERM, Centre de Recherche Saint\u2010Antoine, UMR\u2010S938, AP\u2010HP, Groupe Hospitalier Sorbonne Universit\u00e9, H\u00f4pital Armand Trousseau APHP Sorbonne Universit\u00e9 Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1048-1517","authenticated-orcid":false,"given":"Brigitte","family":"Nelken","sequence":"additional","affiliation":[{"name":"CHU de Lille, H\u00f4pital Jeanne de Flandre Lille France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5178-0655","authenticated-orcid":false,"given":"Antonis","family":"Kattamis","sequence":"additional","affiliation":[{"name":"Pediatric Hematology\u2010Oncology Unit, First Department of Pediatrics National and Kapodistrian University of Athens Athens Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4828-3893","authenticated-orcid":false,"given":"Carmelo","family":"Rizzari","sequence":"additional","affiliation":[{"name":"Pediatric Haematology Oncology Unit, Foundation IRCCS San Gerardo dei Tintori University of Milano\u2010Bicocca Monza Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9257-900X","authenticated-orcid":false,"given":"Franca","family":"Fagioli","sequence":"additional","affiliation":[{"name":"Ospedale Regina Margherita Centro Torino Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8698-9547","authenticated-orcid":false,"given":"Simone","family":"Cesaro","sequence":"additional","affiliation":[{"name":"Pediatric Hematology Oncology Azienda Ospedaliera Universitaria Integrata Verona Verona Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7638-5590","authenticated-orcid":false,"given":"Oscar","family":"Gonz\u00e1lez\u2010Llano","sequence":"additional","affiliation":[{"name":"Madero y Gonzalitos S\/N, Col. Mitras Centro Monterrey Nuevo Le\u00f3n Mexico"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5848-4501","authenticated-orcid":false,"given":"Jochen","family":"Buechner","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology and Oncology Oslo University Hospital Oslo Norway"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1601-5648","authenticated-orcid":false,"given":"Willy Qui\u00f1ones","family":"Choque","sequence":"additional","affiliation":[{"name":"Centro M\u00e9dico Monte Carmelo Arequipa Peru"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5332-0284","authenticated-orcid":false,"given":"Joaquin","family":"Duarte","sequence":"additional","affiliation":[{"name":"Pediatric Oncology Department Instituto Portugu\u00eas de Oncologia de Lisboa Lisbon Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9240-3522","authenticated-orcid":false,"given":"Jonas","family":"Abrahamsson","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Institution for Clinical Sciences, Sahlgrenska University Hospital University of Gothenburg Gothenburg Sweden"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ada","family":"Alarc\u00f3n","sequence":"additional","affiliation":[{"name":"Hematology and Oncology Department Hospital de Pediatr\u00eda Prof. Dr. Juan P. Garrahan Buenos Aires Buenos Aires Argentina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynn","family":"Wang","sequence":"additional","affiliation":[{"name":"Sanofi Cambridge Massachusetts United\u00a0States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9263-6994","authenticated-orcid":false,"given":"Sandrine","family":"Mac\u00e9","sequence":"additional","affiliation":[{"name":"Sanofi Vitry\u2010sur\u2010Seine France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corina","family":"Oprea","sequence":"additional","affiliation":[{"name":"Sanofi Vitry\u2010sur\u2010Seine France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0007-2823-1870","authenticated-orcid":false,"given":"Giovanni","family":"Abbadessa","sequence":"additional","affiliation":[{"name":"Sanofi Cambridge Massachusetts United\u00a0States"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6892-8268","authenticated-orcid":false,"given":"C. Michel","family":"Zwaan","sequence":"additional","affiliation":[{"name":"Princess M\u00e1xima Centre for Pediatric Oncology Utrecht The Netherlands"},{"name":"Department of Pediatric Oncology Erasmus MC\u2010Sophia Children's Hospital Rotterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,10,30]]},"reference":[{"key":"e_1_2_13_2_1","unstructured":"Key statistics for childhood leukemia. American Cancer Society. Accessed August 29 2023.https:\/\/www.cancer.org\/content\/dam\/CRC\/PDF\/Public\/8693.00.pdf"},{"key":"e_1_2_13_3_1","volume-title":"SEER Cancer Statistics Review (CSR) 1975\u20132018, Childhood Cancer by the ICCC","author":"Howlader N","year":"2021"},{"key":"e_1_2_13_4_1","unstructured":"Survival rates for childhood leukemias. American Cancer Society. Accessed January 24 2023.https:\/\/www.cancer.org\/cancer\/leukemia-in-children\/detection-diagnosis-staging\/survival-rates.html"},{"issue":"11","key":"e_1_2_13_5_1","doi-asserted-by":"crossref","first-page":"2316","DOI":"10.1038\/s41375-018-0094-0","article-title":"Outcome of children with multiply relapsed B\u2010cell acute lymphoblastic leukemia: a therapeutic advances in childhood leukemia & lymphoma study","volume":"32","author":"Sun W","year":"2018","journal-title":"Leukemia"},{"issue":"18","key":"e_1_2_13_6_1","doi-asserted-by":"crossref","first-page":"2174","DOI":"10.1200\/JCO.23.01841","article-title":"Mitoxantrone versus liposomal daunorubicin in induction of pediatric AML with risk stratification based on flow cytometry measurement of residual disease","volume":"42","author":"Tierens A","year":"2024","journal-title":"J Clin Oncol"},{"issue":"27","key":"e_1_2_13_7_1","doi-asserted-by":"crossref","first-page":"2949","DOI":"10.1200\/JCO.2015.62.8289","article-title":"Collaborative efforts driving progress in pediatric acute myeloid leukemia","volume":"33","author":"Zwaan CM","year":"2015","journal-title":"J Clin Oncol"},{"issue":"1","key":"e_1_2_13_8_1","first-page":"2655","article-title":"Pre\u2010clinical efficacy of the anti\u2010CD38 monoclonal antibody (mAb) isatuximab in acute myeloid leukemia (AML)","volume":"130","author":"Jelinek T","year":"2017","journal-title":"Blood"},{"issue":"10","key":"e_1_2_13_9_1","doi-asserted-by":"crossref","first-page":"1916","DOI":"10.1158\/1535-7163.MCT-21-0058","article-title":"Evaluation of preclinical activity of isatuximab in patients with acute lymphoblastic leukemia","volume":"20","author":"Wang A","year":"2021","journal-title":"Mol Cancer Ther"},{"issue":"17","key":"e_1_2_13_10_1","doi-asserted-by":"crossref","first-page":"4574","DOI":"10.1158\/1078-0432.CCR-14-0695","article-title":"SAR650984, a novel humanized CD38\u2010targeting antibody, demonstrates potent antitumor activity in models of multiple myeloma and other CD38+ hematologic malignancies","volume":"20","author":"Deckert J","year":"2014","journal-title":"Clin Cancer Res"},{"issue":"12","key":"e_1_2_13_11_1","doi-asserted-by":"crossref","DOI":"10.3390\/cells8121522","article-title":"Therapeutic opportunities with pharmacological inhibition of CD38 with isatuximab","volume":"8","author":"Martin TG","year":"2019","journal-title":"Cells"},{"issue":"1","key":"e_1_2_13_12_1","doi-asserted-by":"crossref","first-page":"13","DOI":"10.1182\/blood-2017-06-740944","article-title":"CD38 antibodies in multiple myeloma: back to the future","volume":"131","author":"Donk NWCJ","year":"2018","journal-title":"Blood"},{"key":"e_1_2_13_13_1","doi-asserted-by":"crossref","DOI":"10.3389\/fimmu.2020.01771","article-title":"Isatuximab acts through Fc\u2010dependent, independent, and direct pathways to kill multiple myeloma cells","volume":"11","author":"Zhu C","year":"2020","journal-title":"Front Immunol"},{"key":"e_1_2_13_14_1","unstructured":"Sarclisa\u00ae (isatuximab\u2010irfc) injection for intravenous use. Prescribing information. Sanofi\u2010Aventis U.S. LLC. Accessed May 9 2025.https:\/\/products.sanofi.us\/sarclisa\/sarclisa.pdf"},{"key":"e_1_2_13_15_1","unstructured":"Sarclisa\u2014isatuximab. European Medicines Agency. Accessed May 9 2025.https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/sarclisa"},{"key":"e_1_2_13_16_1","unstructured":"Sanofi K.K. Pharmaceuticals and Medical Devices Agency. 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A retrospective observational Campus ALL study","volume":"107","author":"Cerrano M","year":"2022","journal-title":"Haematologica"},{"issue":"5","key":"e_1_2_13_30_1","doi-asserted-by":"crossref","first-page":"e200","DOI":"10.1097\/MPH.0b013e318290c3d6","article-title":"Outcome of children and adolescents with a second or third relapse of acute lymphoblastic leukemia (ALL): a population\u2010based analysis of the Austrian ALL\u2010BFM (Berlin\u2010Frankfurt\u2010Munster) study group","volume":"35","author":"Reismuller B","year":"2013","journal-title":"J Pediatr Hematol Oncol"}],"container-title":["HemaSphere"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/hem3.70245","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,30]],"date-time":"2025-10-30T12:15:55Z","timestamp":1761826555000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/hem3.70245"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10]]},"references-count":29,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2025,10]]}},"alternative-id":["10.1002\/hem3.70245"],"URL":"https:\/\/doi.org\/10.1002\/hem3.70245","archive":["Portico"],"relation":{},"ISSN":["2572-9241","2572-9241"],"issn-type":[{"value":"2572-9241","type":"print"},{"value":"2572-9241","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10]]},"assertion":[{"value":"2025-02-17","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-07-02","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70245"}}