{"entity":{"id":"graall-2005","kind":"trial","name":"GRAALL-2005","aka":["GRAALL 2005","GRAALL"],"tldr":"GRAALL-2005 treated adults with acute lymphoblastic leukaemia using an intensive protocol borrowed from children's medicine and asked whether giving cyclophosphamide in a more intense split schedule helped; it did not, and the trial also showed that people aged 55 and over tolerate the paediatric-style treatment poorly.","summary":"GRAALL-2005 was the French, Belgian and Swiss GRAALL group's randomised phase 3 protocol for adults aged 18 to 59 with newly diagnosed acute lymphoblastic leukaemia. Patients were assigned by immunophenotype and genetics to three linked trials (T-cell or Philadelphia-negative B-cell disease, CD20-positive B-cell disease with or without rituximab, and Philadelphia-positive disease under GRAAPH-2005). The paediatric-inspired backbone came from the earlier GRAALL-2003 study. The randomised question reported in 2018 was whether hyperfractionated cyclophosphamide in first induction and late intensification improved outcomes.\n\nAmong 787 evaluable patients the complete remission rate was 91.9 percent, five-year event-free survival 52.2 percent and overall survival 58.5 percent. Hyperfractionated cyclophosphamide did not raise the remission rate or lengthen event-free or overall survival, except in the minority aged 55 and over, who otherwise tolerated the whole programme poorly. The protocol is one of the reference paediatric-inspired regimens for younger adults, alongside CALGB 10403 and UKALL.","status":"completed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT00327678","url":"https://clinicaltrials.gov/study/NCT00327678"}],"tags":["soc-trials"],"related":[],"cancers":["all-leukemia","leukaemia"],"sections":[],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["cyclophosphamide"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-graall-2005-huguet-jco-2018"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00327678","phase":"3","setting":"Adults aged 18 to 59 with newly diagnosed Philadelphia-negative acute lymphoblastic leukaemia treated with a paediatric-inspired protocol: standard-dose or hyperfractionated cyclophosphamide during induction and late intensification","sponsor":"Assistance Publique - Hôpitaux de Paris","result":"Hyperfractionated cyclophosphamide did not improve remission, event-free or overall survival; five-year event-free survival was 52.2 percent overall and 55.7 percent under age 55 against 25.8 percent at 55 and over.","yearReported":2018,"enrolled":1080,"enrolledBasis":"registry","outcomes":[{"endpoint":"Complete remission","unit":"%","arms":[{"name":"All evaluable patients on the paediatric-inspired protocol","n":787,"value":91.9}],"source":"https://doi.org/10.1200/jco.2017.76.8192"},{"endpoint":"Event-free survival at 5 years","primary":true,"unit":"%","arms":[{"name":"All evaluable patients on the paediatric-inspired protocol","n":787,"value":52.2,"note":"95% CI 48.5 to 55.7; hyperfractionated cyclophosphamide did not change the rate"}],"source":"https://doi.org/10.1200/jco.2017.76.8192"},{"endpoint":"Overall survival at 5 years","unit":"%","arms":[{"name":"All evaluable patients on the paediatric-inspired protocol","n":787,"value":58.5,"note":"95% CI 54.8 to 61.9"}],"source":"https://doi.org/10.1200/jco.2017.76.8192"},{"endpoint":"Event-free survival at 5 years by age","unit":"%","arms":[{"name":"Age under 55","value":55.7},{"name":"Age 55 and over","value":25.8}],"hr":2.16,"p":"<0.001","source":"https://doi.org/10.1200/jco.2017.76.8192"}]},"route":"/trials/graall-2005/","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/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"cyclophosphamide","kind":"drug","name":"Cyclophosphamide","route":"/drugs/cyclophosphamide/"}],"paper":[{"id":"paper-graall-2005-huguet-jco-2018","kind":"paper","name":"GRAALL-2005: randomised hyperfractionated cyclophosphamide in a paediatric-inspired adult ALL protocol","route":"/key-papers/paper-graall-2005-huguet-jco-2018/"}]}}