Phase 2 Study of ACP-196 for Treating Waldenström Macroglobulinemia

Sponsor: Acerta Pharma BV

Sponsor score: 0

ClinicalTrials ID:NCT02180724

This study is testing the safety and effectiveness of a new drug, acalabrutinib, for treating Waldenström Macroglobulinemia (WM), a type of blood cancer. The study aims to understand how the drug works in the body and its impact on the disease.

Patient Parameters

Parameter	Options

Program Overview

The study is focused on evaluating a new treatment called acalabrutinib for patients with Waldenström Macroglobulinemia (WM), a type of non-Hodgkin lymphoma. Acalabrutinib is designed to target a specific pathway in cancer cells, potentially offering benefits for patients with WM. The study will assess how safe the drug is, how it behaves in the body, and how effective it is in treating WM.

Description

Acalabrutinib is a new drug developed to target a specific protein in cancer cells called Bruton tyrosine kinase (BTK). This protein is involved in the growth of certain types of cancer, including Waldenström Macroglobulinemia (WM). The drug is taken orally and has shown promise in early studies for treating WM and other similar cancers. This study will look at how safe acalabrutinib is, how it is processed by the body, and how well it works in reducing cancer symptoms. Participants will take the drug and undergo various tests to monitor their health and the drug's effects.

Eligibility Criteria

Inclusion Criteria

Adults aged 18 and older.
For those who have been treated before: Must have a confirmed diagnosis of WM that has returned or not responded to at least one previous treatment and needs further treatment.
For those who have not been treated before: Must have a confirmed diagnosis of WM that requires treatment and either do not want chemotherapy or cannot have it due to other health issues.
Must have certain levels of IgM in the blood or measurable lymph nodes affected by WM.
Must be in relatively good health with an ECOG performance status of 0 to 2.
Women who can become pregnant must use effective birth control during the study and for 2 days after the last dose.
Must be willing to participate in all study procedures and evaluations, including taking capsules.
Must understand the study and agree to provide informed consent.

Exclusion Criteria

Have had another type of cancer, except for certain skin cancers or other cancers that have been in remission for at least 2 years.
Have a serious illness or medical condition that could interfere with the study or the drug's absorption.
Have significant heart disease or recent heart attack.
Have digestive issues that affect the stomach or intestines.
Have received immunotherapy within 4 weeks before starting the study drug.
Have taken certain cancer drugs recently.
Have used other BTK or BCL-2 inhibitors before.
Are on ongoing immunosuppressive therapy, except for certain low-dose steroids.
Have ongoing side effects from previous cancer treatments.
Have a history of HIV, hepatitis C, or hepatitis B, or any active infection.
Have had major surgery within 4 weeks before starting the study drug.
Have certain blood disorders or bleeding conditions.
Have had a stroke or brain bleed within 6 months before starting the study drug.
Are taking blood thinners like warfarin.
Need to take proton-pump inhibitors.
Have low blood cell counts or high levels of creatinine, bilirubin, AST, or ALT.
Are pregnant or breastfeeding.
Are participating in another clinical trial.

Locations

FACILITY	ZIP	CITY	STATE
Research Site	93105	Santa Barbara	California
Research Site	80012	Aurora	Colorado
Research Site	20007	Washington D.C.	District of Columbia
Research Site	55404	Minneapolis	Minnesota
Research Site	10021	New York	New York
Research Site	37203	Nashville	Tennessee
Research Site	78705	Austin	Texas
Research Site	76022	Bedford	Texas
Research Site	77030	Houston	Texas
Research Site	98684	Vancouver	Washington

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.