{"entity":{"id":"esphall","kind":"trial","name":"EsPhALL (EsPhALL2004 and EsPhALL2010)","aka":["EsPhALL","ESPHALL","EsPhALL2004","EsPhALL2010"],"tldr":"EsPhALL is the European intergroup study that brought the leukaemia pill imatinib into treatment for children with Philadelphia-positive acute lymphoblastic leukaemia; the first version gave it in short bursts after induction and the second gave it continuously, and together they set the chemotherapy backbone that the standard of care still uses.","summary":"EsPhALL was an intergroup study across ten European groups, Chile and Hong Kong for children with Philadelphia chromosome-positive acute lymphoblastic leukaemia identified on national front-line trials. In EsPhALL2004 (2004 to 2009) good-risk patients, defined by early response, were randomised to post-induction imatinib with chemotherapy or chemotherapy alone, and all poor-risk patients received imatinib; the backbone was a Berlin-Frankfurt-Munster high-risk regimen with transplant after four post-induction blocks. Four-year disease-free survival in good-risk patients was 72.9 percent with imatinib against 61.7 percent without, a difference that was not statistically significant in the intention-to-treat analysis, and four-year event-free survival in poor-risk patients was 53.5 percent.\n\nEsPhALL2010 (2010 to 2014) gave imatinib continuously from day 15 of induction and through chemotherapy, with transplant reserved for poor early responders: 155 patients had five-year event-free survival of 57.0 percent and overall survival of 71.8 percent, similar to EsPhALL2004 despite transplanting fewer patients, at the cost of more toxicity during intensive blocks. The paediatric Philadelphia-positive leukaemia page describes imatinib given through induction and continued throughout EsPhALL-type chemotherapy on this evidence.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00287105","url":"https://clinicaltrials.gov/study/NCT00287105"}],"tags":["soc-trials"],"related":[],"cancers":["all-paediatric-ph-positive","all-leukemia","leukaemia"],"sections":[],"technologies":["kinase-inhibitors","cytotoxic-chemotherapy","allogeneic-hsct"],"targets":[],"drugs":["imatinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-esphall-imatinib-biondi-lancet-oncol-2012","paper-esphall2010-continuous-imatinib-biondi-lancet-haematol-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00287105","phase":"2","setting":"Children and adolescents aged 1 to 17 with Philadelphia chromosome-positive acute lymphoblastic leukaemia treated on national front-line trials: imatinib with a BFM high-risk chemotherapy backbone and transplant for the higher-risk, first as short discontinuous courses after induction (EsPhALL2004, randomised in good-risk patients) and then continuously from day 15 of induction (EsPhALL2010, single arm)","sponsor":"Rennes University Hospital","result":"Imatinib with BFM chemotherapy gave four-year disease-free survival of 72.9 percent against 61.7 percent without imatinib in good-risk children (not significant); continuous imatinib from day 15 in EsPhALL2010 gave five-year event-free survival of 57.0 percent and overall survival of 71.8 percent with fewer transplants.","yearReported":2018,"enrolled":178,"enrolledBasis":"registered","enrolledNote":"The registry lists 49 patients because most were registered through their national front-line trials; the EsPhALL2004 report enrolled 178 patients (108 good risk, 70 poor risk) and the single-arm EsPhALL2010 amendment a further 155.","outcomes":[{"endpoint":"Disease-free survival at 4 years, good-risk patients (EsPhALL2004)","primary":true,"unit":"%","arms":[{"name":"Post-induction imatinib + chemotherapy","n":46,"value":72.9,"note":"95% CI 56.1 to 84.1"},{"name":"Chemotherapy alone","n":44,"value":61.7,"note":"95% CI 45.0 to 74.7"}],"hr":0.63,"ci":[0.28,1.41],"p":"0.24","source":"https://doi.org/10.1016/S1470-2045(12)70377-7"},{"endpoint":"Event-free survival at 4 years, poor-risk patients (EsPhALL2004, all given imatinib)","primary":true,"unit":"%","arms":[{"name":"Post-induction imatinib + chemotherapy","n":70,"value":53.5,"note":"95% CI 40.4 to 65.0"}],"source":"https://doi.org/10.1016/S1470-2045(12)70377-7"},{"endpoint":"Event-free survival at 5 years (EsPhALL2010, continuous imatinib)","primary":true,"unit":"%","arms":[{"name":"Imatinib from day 15 of induction + chemotherapy","n":155,"value":57,"note":"95% CI 48.5 to 64.6; 38% transplanted in first remission"}],"source":"https://doi.org/10.1016/S2352-3026(18)30173-X"},{"endpoint":"Overall survival at 5 years (EsPhALL2010, continuous imatinib)","primary":true,"unit":"%","arms":[{"name":"Imatinib from day 15 of induction + chemotherapy","n":155,"value":71.8,"note":"95% CI 63.5 to 78.5"}],"source":"https://doi.org/10.1016/S2352-3026(18)30173-X"}]},"route":"/trials/esphall/","neighbours":{"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"leukaemia","kind":"cancer","name":"Leukaemia (all types)","route":"/cancers/leukaemia/"},{"id":"all-paediatric-ph-positive","kind":"cancer","name":"Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL)","route":"/cancers/all-paediatric-ph-positive/"}],"technology":[{"id":"allogeneic-hsct","kind":"technology","name":"Allogeneic stem cell transplantation","route":"/technologies/allogeneic-hsct/"},{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"imatinib","kind":"drug","name":"Imatinib","route":"/drugs/imatinib/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"paper":[{"id":"paper-esphall-imatinib-biondi-lancet-oncol-2012","kind":"paper","name":"EsPhALL: imatinib after induction for children and adolescents with Philadelphia chromosome-positive acute lymphoblastic leukaemia","route":"/key-papers/paper-esphall-imatinib-biondi-lancet-oncol-2012/"},{"id":"paper-esphall2010-continuous-imatinib-biondi-lancet-haematol-2018","kind":"paper","name":"EsPhALL2010: continuous imatinib with chemotherapy in paediatric Philadelphia chromosome-positive ALL","route":"/key-papers/paper-esphall2010-continuous-imatinib-biondi-lancet-haematol-2018/"}]}}