Study on Adding Venetoclax to Usual Chemotherapy for High-Grade B-Cell Lymphomas
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT03984448
This clinical trial is exploring whether adding a new drug, venetoclax, to the standard chemotherapy can better prevent high-grade B-cell lymphomas from returning or worsening. Venetoclax works by blocking a protein that helps cancer cells survive, potentially making the treatment more effective.
Patient Parameters
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Program Overview
The purpose of this study is to see if adding venetoclax to the usual chemotherapy drugs can improve treatment outcomes for patients with high-grade B-cell lymphomas. Venetoclax may help stop cancer cells from growing by blocking a protein called Bcl-2. The standard chemotherapy includes drugs like rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, which work in different ways to kill cancer cells or stop them from spreading. The study aims to find out if this combination can increase the chances of the cancer going into remission and not coming back.
Description
The main goal of this study is to compare how long patients live without their cancer getting worse when treated with rituximab-based chemotherapy plus venetoclax versus rituximab-based chemotherapy alone. The study will also look at overall survival, event-free survival, and response rates between the two treatment groups. Researchers will assess the safety and side effects of the treatments and explore how different factors, like protein expression in the cancer cells, might affect outcomes.
Participants will be randomly assigned to one of two groups. In one group, patients will receive the standard chemotherapy regimen, while in the other group, patients will receive the same chemotherapy plus venetoclax. The treatment will be given in cycles, with each cycle lasting 21 days, and will continue for up to six cycles unless the cancer progresses or side effects become too severe.
Throughout the study, patients will undergo various tests, including PET and CT scans, blood tests, and possibly bone marrow biopsies and lumbar punctures, to monitor their response to treatment. After completing the treatment, patients will have regular follow-up visits to check their health and cancer status for up to 10 years.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL) that meets specific criteria.
- Have a type of lymphoma known as double hit lymphoma (DHL) or double expressing lymphoma (DEL).
- Have not received prior treatment for DLBCL/HGBCL, except for certain allowed treatments like corticosteroids or a single cycle of specific chemotherapy.
- Be between 18 and 80 years old.
- Have a performance status score of 0 to 2, indicating good overall health.
- Meet specific blood count and organ function requirements.
- Not be pregnant or nursing, and women of childbearing potential must have a negative pregnancy test before joining the study.
- Have no active heart disease, HIV, or hepatitis infections, with some exceptions for controlled conditions.
- Not be taking certain medications that interact with venetoclax.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | 35233 | Birmingham | Alabama |
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Anchorage Radiation Therapy Center | 99504 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
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