IRB #

STUDY00015680

Title

A Phase Ib/II, Open label, Single Arm, Multi-center, Dose Escalation Trial of Intravenous BI 836826 in Combination with Ibrutinib in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

Principal Investigator

Alexey Danilov

Study Purpose

This is a two part study that will be exploring the safety and effectiveness of combining the study drug, BI 836826, with ibrutinib in participants with relapsed/refractory CLL.

The purpose of the first part of the study is to:
• To determine the recommended dose of the study drug in combination with ibrutinib in participants with relapsed/refractory CLL
• Test the safety and effectiveness of the study drug in combination with ibrutinib

The purpose of the second part of the study is to:
• Investigate the number of participants who respond to the combination of ibrutinib and the study drug based on the investigator’s assessment

Medical Condition(s)

Chronic lymphocytic leukemia (CLL)

Eligibility Criteria

• At least 18 years of age
• Diagnosed with CLL, have relapsed/refractory disease pre-treated with at least one prior line of systemic treatment and qualify for treatment with ibrutinib
• No prior treatment with ibrutinib or another BTK-inhibitor

Age Range

18 - 99

Healthy Volunteers Needed

No

Duration of Participation

Your participation will last approximately 14 months, with the possibility of the study drug treatment period being extended if you are tolerating and responding to the combination treatments. After the study treatment is finished, you will have long-term follow-up visits to assess your disease.

Minors Included

No

Contact

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

Sponsor

Boehringer Ingelheim Pharmaceuticals, Inc.

Recruitment End

01/01/2020

Compensation Provided

No


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