{"entity":{"id":"morpho","kind":"trial","name":"MORPHO","aka":["BMT CTN 1506","2215-CL-0304"],"tldr":"MORPHO asked whether taking the FLT3 blocker gilteritinib for two years after a stem-cell transplant keeps leukaemia from returning; across everyone the benefit fell just short of statistical proof, but in the half of patients whose blood tests still showed traces of leukaemia the drug clearly cut relapses.","summary":"MORPHO (BMT CTN 1506) was a double-blind, placebo-controlled phase 3 trial run by Astellas with the Blood and Marrow Transplant Clinical Trials Network. Adults with FLT3-ITD acute myeloid leukaemia in first remission who had undergone allogeneic transplant were randomised to gilteritinib or placebo for 24 months. The primary endpoint was relapse-free survival; measurable residual disease (MRD) for FLT3-ITD was assessed before and after transplant with a highly sensitive assay.\n\nRelapse-free survival favoured gilteritinib but the difference was not statistically significant (hazard ratio 0.679, two-sided p 0.0518). About half of participants had detectable MRD before or after transplant, and in that prespecified subgroup gilteritinib halved the hazard of relapse or death, while patients without detectable MRD gained nothing. The trial is one of the first to support choosing post-transplant therapy by MRD, and the standard-of-care text for acute myeloid leukaemia describes FLT3 inhibitor maintenance after transplant for MRD-positive disease on this evidence.","status":"mixed","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02997202","url":"https://clinicaltrials.gov/study/NCT02997202"}],"tags":["soc-trials"],"related":[],"cancers":["aml-flt3","aml","leukaemia"],"sections":[],"technologies":["kinase-inhibitors","allogeneic-hsct","mrd-testing"],"targets":[],"drugs":["gilteritinib"],"companies":["astellas"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-morpho-gilteritinib-levis-jco-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02997202","phase":"3","setting":"FLT3-ITD acute myeloid leukaemia in first remission after allogeneic transplant: gilteritinib 120 mg or placebo daily for 24 months as post-transplant maintenance, with measurable residual disease measured before and after transplant","sponsor":"Astellas Pharma Global Development, Inc.","result":"Relapse-free survival hazard ratio 0.679 for gilteritinib against placebo, not statistically significant overall; in the prespecified MRD-positive half of patients the hazard ratio was 0.515, with no benefit in MRD-negative patients.","yearReported":2024,"enrolled":356,"enrolledBasis":"registry","outcomes":[{"endpoint":"Relapse-free survival","primary":true,"arms":[{"name":"Gilteritinib maintenance","note":"Median not reached in either arm; 356 randomised"},{"name":"Placebo"}],"hr":0.679,"ci":[0.459,1.005],"p":"0.0518","source":"https://doi.org/10.1200/jco.23.02474"},{"endpoint":"Relapse-free survival, MRD detectable before or after transplant (prespecified subgroup, 50.5% of participants)","arms":[{"name":"Gilteritinib maintenance"},{"name":"Placebo"}],"hr":0.515,"ci":[0.316,0.838],"p":"0.0065","source":"https://doi.org/10.1200/jco.23.02474"},{"endpoint":"Relapse-free survival, MRD not detectable","arms":[{"name":"Gilteritinib maintenance"},{"name":"Placebo"}],"hr":1.213,"ci":[0.616,2.387],"p":"0.575","source":"https://doi.org/10.1200/jco.23.02474"}]},"route":"/trials/morpho/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-flt3","kind":"cancer","name":"FLT3-mutated acute myeloid leukaemia","route":"/cancers/aml-flt3/"},{"id":"leukaemia","kind":"cancer","name":"Leukaemia (all types)","route":"/cancers/leukaemia/"}],"technology":[{"id":"allogeneic-hsct","kind":"technology","name":"Allogeneic stem cell transplantation","route":"/technologies/allogeneic-hsct/"},{"id":"mrd-testing","kind":"technology","name":"MRD / molecular residual disease testing","route":"/technologies/mrd-testing/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"gilteritinib","kind":"drug","name":"Gilteritinib","route":"/drugs/gilteritinib/"}],"company":[{"id":"astellas","kind":"company","name":"Astellas","route":"/companies/astellas/"}],"paper":[{"id":"paper-morpho-gilteritinib-levis-jco-2024","kind":"paper","name":"MORPHO: gilteritinib as post-transplant maintenance for FLT3-ITD acute myeloid leukaemia","route":"/key-papers/paper-morpho-gilteritinib-levis-jco-2024/"}]}}