IRB #

STUDY00016624

Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Bendamustine and Rituximab (BR) Alone Versus in Combination with Acalabrutinib (ACP-196) in Subjects with Previously Untreated Mantle Cell Lymphoma

Principal Investigator

Stephen Spurgeon

Study Purpose

The purpose of this study is to determine if giving an experimental drug called acalabrutinib (ACP-196) in combination with bendamustine and rituximab (BR) is safe and effective for treating people with mantle cell lymphoma (MCL) compared to BR with placebo. This is a randomized, double-blinded, and placebo-controlled study. Double-blinded means neither you nor the investigator will know whether you are taking the study drug or placebo. Placebo-controlled means you will be taking a capsule with no medicine in it but it will look like the study drug, acalabrutinib.

Medical Condition(s)

Previously untreated mantle cell lymphoma (MCL)

Eligibility Criteria

- Be 65 years of age or older
- Have been diagnosed with mantle cell lymphoma
- Have not received previous treatment for your mantle cell lymphoma

Age Range

65 - 99

Healthy Volunteers Needed

No

Duration of Participation

Your participation may last up to 68 months (approximately 5.6 years). The investigator will inform you if your participation will last longer than 68 months. You may continue to receive study drug as long as you and the investigator feel that you are tolerating the study drug and your disease is not getting worse.

Minors Included

No

Contact

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

Sponsor

Acerta Pharma, BV

Recruitment End

11/01/2020

Compensation Provided

No


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