A Phase IB/II Study of BI 836858 plus Azacitidine in Patients 60 and Older with Newly Diagnosed Acute Myeloid Leukemia

Full Title

BAML-16-001-S2: Phase Ib/II1b/2 Study of BI 836858 with Azacitidine in Previously Untreated Acute Myeloid Leukemia (AML) Patients >60 Years With Unique Molecular Features (WIRB)


Azacitidine is a drug used to treat acute myeloid leukemia (AML). In this study, researchers are finding the highest dose of the investigational drug BI 836858 that can be given with azacitidine in patients age 60 and older newly diagnosed with AML that has certain genetic mutations. They also want to see how effective this therapy is in these patients.

BI 836858 works by inhibiting a protein on some AML cells called CD33. Both BI 836858 and azacitidine are given intravenously (by vein).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have previously untreated AML with a mutation in the TET2, IDH1, or WT1 genes.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 60 and older.

For more information about this study and to inquire about eligibility, please contact Dr Eytan Stein at 212-639-3314.