{"entity":{"id":"study-0201","kind":"trial","name":"Study 0201","aka":["0201","MAXIM-MP-MA-0201","CWRU-MAXI-1998","Ceplene pivotal trial"],"tldr":"Study 0201 showed that histamine injections given with low-dose interleukin-2 after consolidation helped more adults with acute myeloid leukaemia in first remission stay free of leukaemia at three years than observation alone, and it was the main evidence for the EU authorisation of Ceplene.","summary":"Study 0201 was a multicentre, randomised, open-label phase 3 trial of post-consolidation immunotherapy with histamine dihydrochloride plus interleukin-2 in adults with acute myeloid leukaemia in complete remission. Three hundred and twenty patients (median age 57 years, range 18 to 84) were stratified by first complete remission or subsequent remission and assigned to histamine dihydrochloride 0.5 mg plus interleukin-2 16,400 units per kilogram, both injected under the skin twice daily for ten 21-day cycles, or to no further therapy. Study arms were balanced for age, sex, previous treatment, karyotype, time from remission to inclusion and secondary leukaemia.\n\nThree years after the last patient was enrolled, leukaemia-free survival was better with histamine plus interleukin-2 than with observation in the full population (n = 320, P less than .01, log-rank). In first complete remission (n = 261), three-year leukaemia-free survival was 40 percent with the combination against 26 percent with observation (P = .01). Side effects were typically mild to moderate (Blood 2006).\n\nThe EMA overview describes one main study of 320 adults with acute myeloid leukaemia in remission, in which Ceplene with interleukin-2 was compared with no treatment. The European Commission authorised Ceplene on 7 October 2008 under exceptional circumstances for maintenance with interleukin-2 in adults in first remission; the marketing authorisation holder is Laboratoires Delbert. The registry records the study as completed under secondary id MAXIM-MP-MA-0201 and posts no results.","status":"positive","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT00003991","url":"https://clinicaltrials.gov/study/NCT00003991"},{"label":"Blood 2006","url":"https://doi.org/10.1182/blood-2005-10-4073"},{"label":"Ceplene EPAR (EMA)","url":"https://www.ema.europa.eu/en/medicines/human/EPAR/ceplene"}],"tags":[],"related":[],"cancers":["aml"],"sections":[],"technologies":["cytokine-therapy"],"targets":[],"drugs":["histamine-dihydrochloride","aldesleukin"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-study-0201-blood-2006"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00003991","phase":"3","setting":"Adults with acute myeloid leukaemia in first or subsequent complete remission after consolidation: histamine dihydrochloride plus low-dose interleukin-2 against no further therapy","sponsor":"Maxim Pharmaceuticals","result":"Leukaemia-free survival improved over observation in the full population (n=320, P<.01); in first complete remission, 3-year leukaemia-free survival 40% with histamine plus interleukin-2 against 26% with observation (P=.01).","yearReported":2006,"enrolled":320,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov NCT00003991 posts an estimated enrolment of 360 and no actual count; the Blood 2006 abstract and the EMA overview both count 320 randomised patients.","outcomes":[{"endpoint":"Leukaemia-free survival at 3 years, first complete remission subgroup","unit":"%","arms":[{"name":"Histamine dihydrochloride plus interleukin-2","value":40,"note":"First-remission subgroup (n = 261 across both arms); the primary analysis in all 320 patients reported P < .01 without printed rates"},{"name":"No further therapy (observation)","value":26}],"p":"0.01","source":"https://doi.org/10.1182/blood-2005-10-4073"}]},"route":"/trials/study-0201/","neighbours":{"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"}],"technology":[{"id":"cytokine-therapy","kind":"technology","name":"Cytokines & engineered cytokines","route":"/technologies/cytokine-therapy/"}],"drug":[{"id":"aldesleukin","kind":"drug","name":"Aldesleukin (high-dose IL-2)","route":"/drugs/aldesleukin/"},{"id":"histamine-dihydrochloride","kind":"drug","name":"Histamine dihydrochloride","route":"/drugs/histamine-dihydrochloride/"}],"paper":[{"id":"paper-study-0201-blood-2006","kind":"paper","name":"Improved leukemia-free survival after postconsolidation immunotherapy with histamine dihydrochloride and interleukin-2 in acute myeloid leukemia: results of a randomized phase 3 trial","route":"/key-papers/paper-study-0201-blood-2006/"}]}}