Study on Acalabrutinib Combined with R-CHOP for Untreated Non-GCB Diffuse Large B-Cell Lymphoma
Sponsor: Acerta Pharma BV
ClinicalTrials ID:NCT04529772
This clinical trial is testing whether adding the drug acalabrutinib to the standard R-CHOP chemotherapy regimen is safe and effective for patients aged 75 or younger with a specific type of untreated diffuse large B-cell lymphoma (DLBCL).
Patient Parameters
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Program Overview
The purpose of this study is to evaluate if combining acalabrutinib with the standard chemotherapy treatment R-CHOP can improve outcomes for patients with a type of diffuse large B-cell lymphoma (DLBCL) that has not been treated before. The study will compare this combination to the standard R-CHOP treatment alone in patients aged 75 or younger.
Description
This study is a Phase 3 trial, which means it is testing the effectiveness and safety of a new treatment approach in a larger group of patients. The trial is designed to see if adding acalabrutinib to the standard chemotherapy regimen known as R-CHOP can help patients with a specific type of diffuse large B-cell lymphoma (DLBCL) that has not been treated before. R-CHOP includes the drugs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone. Participants will be randomly assigned to receive either the new combination treatment or the standard treatment with a placebo. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the new treatment or the placebo until the study is completed.
Eligibility Criteria
Inclusion Criteria
- Men and women aged 18 to 75 years old.
- Diagnosed with diffuse large B-cell lymphoma (DLBCL) and have enough diagnostic material for further testing.
- Have not received any prior treatment for DLBCL.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Have an International Prognostic Index (IPI) score between 1 and 5.
- Have cancer that is classified as Stage II to IV.
- Have adequate organ and bone marrow function.
- Agree to use effective contraception during the study and for 12 months after the last dose of rituximab.
Exclusion Criteria
- Have severe or uncontrolled systemic diseases.
- Have a known bleeding disorder like hemophilia or von Willebrand disease.
- Have had a stroke or brain bleed in the past 6 months.
- Have cancer that has spread to the brain or spinal cord.
- Have primary mediastinal lymphoma.
- Have high-grade B-cell lymphoma with specific genetic changes.
- Have a history of slow-growing lymphoma or chronic lymphocytic leukemia (CLL).
- Have a history of or ongoing progressive multifocal leukoencephalopathy (PML).
- Have significant heart disease, such as uncontrolled arrhythmias or recent heart attack.
- Have digestive issues that affect absorption, like inflammatory bowel disease or previous stomach surgery.
- Have an uncontrolled active infection.
- Have used anthracycline drugs at high doses before.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Research Site | 85711 | Tucson | Arizona |
| Research Site | 72205 | Little Rock | Arkansas |
| Research Site | 92618 | Irvine | California |
| Research Site | 80012 | Aurora | Colorado |
| Research Site | 06360 | Norwich | Connecticut |
| Research Site | 33901 | Fort Myers | Florida |
| Research Site | 32804 | Orlando | Florida |
| Research Site | 33705-1449 | St. Petersburg | Florida |
| Research Site | 32308-5304 | Tallahassee | Florida |
| Research Site | 33401 | West Palm Beach | Florida |
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