A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)


About this study

Phase I Dose Escalation: Primary objective is to determine the MTD and the recommended dose for Phase I Extension. Secondary objective is to investigate the safety, pharmacokinetics and efficacy of BI 836858 in combination with decitabine Phase I Extension: Primary objective is to collect additional data on safety, pharmacokinetics and efficacy and to define the Recommended Phase II Dose (RP2D) of BI 836858 in combination with decitabine. Phase II: Primary objective is to investigate efficacy, safety and pharmacokinetics of BI 836858 in combination with decitabine compared to decitabine monotherapy.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Phase I Dose Escalation:
    • Male or female patients >/= 18 years of age with relapsed or refractory AML;
    • Male or female patients >/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy.
  • Phase I Extension and Phase II:
    • Male or female patients >/= 65 years of age with previously untreated AML ineligible for receiving standard intensive therapy;
    • Histologically or cytologically confirmed AML according to the WHO classification;
    • Patients must be eligible for treatment with decitabine;
    • Eastern co-operative oncology group (ECOG) performance score.

Exclusion Criteria:

  • Acute promyelocytic leukemia (APL, French-American-British (FAB) subtype M3), according to WHO classification.
  • Patients who are candidates for allogeneic stem cell transplantation.
  • Active chronic graft versus host disease requiring immunosuppressive treatment.
  • Phase I extension and Phase II only: Prior treatment with a hypomethylating agent, such as prior treatment for MDS.
  • Prior treatment with Cluster of differentiation 33 (CD33) antibody Further exclusion criteria apply.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

James Foran, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information


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