Acute Myeloid Leukemia Clinical Trial
A Trial to Find and Investigate a Safe Dose of BI 836858 in Combination With Decitabine for Patients With Acute Myeloid Leukemia (AML)
Phase I Dose Escalation:
Primary objective is to determine the Maximum Tolerated Dose (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.
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
2) Histologically or cytologically confirmed AML according to the WHO classification 3) Patients must be eligible for treatment with decitabine 4) Eastern co-operative oncology group (ECOG) performance score =2 at screening Further inclusion criteria apply.
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 Myelodysplastic Syndrome (MDS).
Prior treatment with Cluster of differentiation 33 (CD33) antibody. Further exclusion criteria apply.
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There are 14 Locations for this study
Jacksonville Florida, 32224, United States
Chicago Illinois, 60611, United States
Lake Success New York, 11042, United States
Columbus Ohio, 43210, United States
Augsburg , 86156, Germany
Berlin , 10967, Germany
Dresden , 01307, Germany
Hamburg , 20246, Germany
Jena , 07740, Germany
Münster , 48149, Germany
Brescia , 25123, Italy
Barcelona , 08035, Spain
Barcelona , 08036, Spain
Valencia , 46026, Spain
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