Study on Acalabrutinib for Treating Relapsed or Hard-to-Treat Mantle Cell Lymphoma
Sponsor: Acerta Pharma BV
ClinicalTrials ID:NCT02213926
This clinical trial is testing the safety and effectiveness of a drug called acalabrutinib in patients with Mantle Cell Lymphoma (MCL) that has returned after treatment or did not respond to previous treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The aim of this study is to evaluate how safe and effective acalabrutinib is for patients with Mantle Cell Lymphoma (MCL) that has either come back after treatment or did not respond to previous treatments. Participants will take acalabrutinib twice a day in 28-day cycles, and the treatment will continue until the disease progresses or side effects become unacceptable.
Description
This Phase 2 clinical trial involves multiple centers around the world and is open to patients with Mantle Cell Lymphoma (MCL) that has returned or is resistant to treatment. Participants will take 100 mg of acalabrutinib twice daily in 28-day cycles. The treatment will continue until the cancer worsens or side effects become too severe.
Participants will undergo regular health checks, including blood tests and urine tests, to monitor safety. These checks will be weekly for the first month, every two weeks in the second month, every four weeks from the third to the twelfth month, and every 24 weeks after that. Tumor assessments will be conducted every 8 to 24 weeks to track the cancer's response to the treatment.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 and older.
- Confirmed diagnosis of Mantle Cell Lymphoma (MCL) with specific genetic markers.
- Able to perform daily activities with some limitations (ECOG performance status of 0 to 2).
- Agree to use effective birth control during the study and for 30 days after the last dose if sexually active and capable of having children.
Exclusion Criteria
- Have a serious illness or medical condition that could affect safety or the study's results.
- Have significant heart disease, such as uncontrolled heart rhythm problems, heart failure, or recent heart attack.
- Have digestive system issues that affect the absorption of the medication.
- Are pregnant or breastfeeding.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 33612 | Tampa | Florida |
| Research Site | 60612 | Chicago | Illinois |
| Research Site | 60714 | Niles | Illinois |
| Research Site | 61615 | Peoria | Illinois |
| Research Site | 2215 | Boston | Massachusetts |
| Research Site | 07601 | Hackensack | New Jersey |
| Research Site | 10021 | New York | New York |
| Research Site | 77030 | Houston | Texas |
| Research Site | 98109 | Seattle | Washington |
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