Study on Acalabrutinib Alone or Combined with Other Treatments for B-cell Non-Hodgkin Lymphoma
Sponsor: Acerta Pharma BV
ClinicalTrials ID:NCT02180711
This clinical trial is exploring the safety and effectiveness of the drug acalabrutinib, used alone or with other medications, in treating different types of B-cell Non-Hodgkin Lymphoma that have returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The study aims to understand how safe and effective acalabrutinib is when used alone or with other drugs like rituximab and lenalidomide in patients with B-cell Non-Hodgkin Lymphoma. It focuses on patients whose cancer has come back or hasn't responded to past treatments.
Description
This study is testing the drug acalabrutinib, both by itself and in combination with other treatments, for patients with B-cell Non-Hodgkin Lymphoma. The study is divided into three parts:
- Part 1 looks at the safety of acalabrutinib alone or with rituximab in patients with a type of lymphoma called follicular lymphoma (FL) that has returned or not responded to treatment.
- Part 2 examines how well acalabrutinib works alone or with rituximab in patients with another type of lymphoma called marginal zone lymphoma (MZL).
- Part 3 focuses on the safety of using acalabrutinib with rituximab and lenalidomide in patients with FL.
The study is open-label, meaning both the researchers and participants know which treatment is being given.
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 or older.
- For Part 1: Diagnosed with follicular lymphoma (FL) Grade 1, 2, or 3a that has returned or not responded to at least one previous treatment, or has not been treated before but needs treatment.
- For Part 2: Diagnosed with marginal zone lymphoma (MZL) that has returned or not responded to treatment, including specific subtypes like splenic, nodal, and extranodal MZL.
- Patients with splenic MZL must have another measurable tumor.
- Patients with gastric MALT lymphoma must test negative for Helicobacter pylori.
- For Part 3: Diagnosed with FL Grade 1, 2, or 3a that has returned or not responded to at least one previous treatment and needs treatment.
- Must have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
- Must agree to use contraception during the study and for 30 days after the last dose if they are sexually active and can have children.
Exclusion Criteria
- Have a serious illness or medical condition that could affect safety or the study results.
- Have significant heart disease, such as uncontrolled heart rhythm problems, heart failure, or a recent heart attack.
- Have digestive system issues that affect how the body absorbs or processes the drug, such as certain bowel diseases or surgeries.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85719 | Tucson | Arizona |
| Research Site | 90241 | Downey | California |
| Research Site | 91010 | Duarte | California |
| Research Site | 92708 | Fountain Valley | California |
| Research Site | 90404 | Santa Monica | California |
| Research Site | 33146 | Coral Gables FL | Florida |
| Research Site | 60611 | Chicago | Illinois |
| Research Site | 60612 | Chicago | Illinois |
| Research Site | 60637 | Chicago | Illinois |
| Research Site | 40207 | Louisville | Kentucky |
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