Study on the Effectiveness of ViPOR Combination Therapy for Patients with Difficult-to-Treat Aggressive B-cell Lymphoma
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06649812
This clinical trial is exploring a new combination of drugs called ViPOR to see if it can help treat patients with aggressive B-cell lymphoma that has either returned after treatment or hasn't responded to previous treatments. ViPOR includes a mix of targeted therapies and immunotherapy drugs that work together to attack cancer cells.
Patient Parameters
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Program Overview
This study is testing a combination of drugs known as ViPOR to see how well it works in treating patients with aggressive B-cell lymphoma that has come back or hasn't responded to other treatments. ViPOR includes venetoclax, ibrutinib, prednisone, obinutuzumab, and Revlimid. These drugs work in different ways to stop cancer cells from growing and help the immune system fight the cancer. The study aims to find out if this combination can be an effective treatment option for patients with specific types of aggressive B-cell lymphoma.
Description
The main goal of this study is to see if the ViPOR combination can lead to a complete response, meaning the cancer disappears, in patients with relapsed or refractory aggressive B-cell lymphoma. The study will also look at how long the response lasts, how long patients live without the cancer getting worse, and the overall safety of the treatment.
Patients in the study will take the ViPOR drugs in cycles, with each cycle lasting 21 days. The treatment includes taking venetoclax, ibrutinib, prednisone, and Revlimid by mouth, and receiving obinutuzumab through an IV. Patients will have regular check-ups, including blood tests and scans, to monitor their health and the cancer's response to the treatment.
After finishing the treatment, patients will have follow-up visits every six months for two years, then yearly for up to five years, and will be monitored for survival for up to ten years.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a confirmed diagnosis of aggressive B-cell lymphoma that has returned or not responded to previous treatments.
- Must not have a specific type of lymphoma called primary mediastinal large B-cell lymphoma.
- Must not be pregnant and must agree to use effective birth control during and after the study.
- Must have good blood counts and organ function based on recent tests.
- Must not have active infections or other serious health conditions.
- Must not have had more than three previous lines of chemotherapy.
- Must not have taken certain medications recently that could interfere with the study.
- Must be willing to provide a tumor sample for research purposes.
- Must be able to understand and agree to the study requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
| Cedars Sinai Medical Center | 90048 | Los Angeles | California |
| Smilow Cancer Hospital Care Center - Guilford | 06437 | Guilford | Connecticut |
| Yale University | 06520 | New Haven | Connecticut |
| Kootenai Health - Coeur d'Alene | 83814 | Coeur d'Alene | Idaho |
| Kootenai Clinic Cancer Services - Post Falls | 83854 | Post Falls | Idaho |
| Kootenai Clinic Cancer Services - Sandpoint | 83864 | Sandpoint | Idaho |
| Northwestern University | 60611 | Chicago | Illinois |
| Carle at The Riverfront | 61832 | Danville | Illinois |
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