IRB #

STUDY00016493

Title

Phase 1b/2 Study of BI 836858 with Azacitidine in Previously Untreate AML Patients >60 Years With Unique Molecular Features

Principal Investigator

Uma Borate

Study Purpose

The purpose of this research study is to:

-Identify the maximum tolerated dose; that is, the highest dose of the study drug BI 836858 that does not cause unacceptable side effects, when given in combination with standard doses of azacitidine
-Obtain information on the safety and effectiveness in subjects given BI 836858 and azacitidine
-Determine the complete remission rate for older AML subjects given these drugs
-Measure and evaluate the behavior of BI 836858 in the blood: pharmacokinetics or PK testing (what the body does to the study drug) and pharmacodynamics (what the study drug does to the body)

Medical Condition(s)

Acute Myeloid Leukemia (AML)

Eligibility Criteria

-Participating in the Beat AML umbrella study master protocol (reference IRB# 16475)
-Newly diagnosed with AML
-Age 60 years or older at time of diagnosis

Age Range

60 - 99

Healthy Volunteers Needed

No

Duration of Participation

You may receive the study drug until you decide to stop or your investigator feel you should stop participating in the study. After you finish receiving the study drug, your investigator will continue to watch you for side effects and follow your condition for about 30 days.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Beat AML, LLC, a division of the Leukemia and Lymphoma Society, Inc

Supported by: Boerhinger Ingelhiem

Recruitment End

01/01/2036

Compensation Provided

No


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