Study Phase 3

A Randomized Phase 2/3 Study of DACOGEN® (Decitabine) Plus Talacotuzumab (JNJ-56022473; Anti CD123) Versus DACOGEN (Decitabine) Alone in Patients With AML Who Are Not Candidates for Intensive Chemotherapy

Trial Information

Generic NameDecitabineProduct NameDACOGEN®Therapeutic AreaAntineoplastic and Immunomodulating AgentsProduct ClassAntineoplastic AgentsPharmacological SubgroupAntimetabolitesChemical SubgroupPyrimidine AnaloguesCondition StudiedLeukemia, Myeloid, Acute
Sponsor Protocol Number56022473AML2002Enrollment326Data PartnerJohnson & Johnson% Female45.7%Mean/Median Age (Years)74.8% White87.4%

Supporting Documentation

  • Collected Datasets Available
  • Data Definition Specification Available
  • Protocol with Amendments Available
  • Statistical Analysis Plan Available
  • Clinical Study Report Available

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