# EsPhALL (EsPhALL2004 and EsPhALL2010)

Source: https://onco.cc/trials/esphall/  
OnCo record `esphall` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

EsPhALL2010 (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.

## Fields

- Kind: Trial
- Status: completed
- Last checked: 2026-09-22
- Also known as: EsPhALL; ESPHALL; EsPhALL2004; EsPhALL2010
- Tags: soc-trials
- Registry id: 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
- Enrolled: 178
- 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.
- Outcomes: Disease-free survival at 4 years, good-risk patients (EsPhALL2004): Post-induction imatinib + chemotherapy 72.9% vs Chemotherapy alone 61.7%, HR 0.63; Event-free survival at 4 years, poor-risk patients (EsPhALL2004, all given imatinib): Post-induction imatinib + chemotherapy 53.5%; Event-free survival at 5 years (EsPhALL2010, continuous imatinib): Imatinib from day 15 of induction + chemotherapy 57%; Overall survival at 5 years (EsPhALL2010, continuous imatinib): Imatinib from day 15 of induction + chemotherapy 71.8%

## Sources

- ClinicalTrials.gov NCT00287105: https://clinicaltrials.gov/study/NCT00287105

## Connected records

- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Leukaemia (all types)](https://onco.cc/cancers/leukaemia/), [Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL)](https://onco.cc/cancers/all-paediatric-ph-positive/)
- technologies: [Allogeneic stem cell transplantation](https://onco.cc/technologies/allogeneic-hsct/), [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Imatinib](https://onco.cc/drugs/imatinib/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- key papers: [EsPhALL: imatinib after induction for children and adolescents with Philadelphia chromosome-positive acute lymphoblastic leukaemia](https://onco.cc/key-papers/paper-esphall-imatinib-biondi-lancet-oncol-2012/), [EsPhALL2010: continuous imatinib with chemotherapy in paediatric Philadelphia chromosome-positive ALL](https://onco.cc/key-papers/paper-esphall2010-continuous-imatinib-biondi-lancet-haematol-2018/)

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