# OnCo record study-0201 (trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/trials/study-0201/>
  a schema:MedicalTrial ;
  onco:kind "trial" ;
  schema:identifier "study-0201", "NCT00003991" ;
  schema:name "Study 0201"@en ;
  schema:alternateName "0201"@en, "MAXIM-MP-MA-0201"@en, "CWRU-MAXI-1998"@en, "Ceplene pivotal trial"@en ;
  schema:description "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."@en ;
  schema:url <https://onco.cc/trials/study-0201/> ;
  schema:dateModified "2026-09-24"^^xsd:date ;
  schema:citation <https://clinicaltrials.gov/study/NCT00003991>, <https://doi.org/10.1182/blood-2005-10-4073>, <https://www.ema.europa.eu/en/medicines/human/EPAR/ceplene> ;
  onco:status "positive" ;
  onco:phase "3" ;
  onco:cancers <https://onco.cc/cancers/aml/> ;
  onco:technologies <https://onco.cc/technologies/cytokine-therapy/> ;
  onco:drugs <https://onco.cc/drugs/histamine-dihydrochloride/>, <https://onco.cc/drugs/aldesleukin/> ;
  onco:keyPapers <https://onco.cc/key-papers/paper-study-0201-blood-2006/> .