Venetoclax + Chemotherapy for B-Cell Lymphoma
Trial Summary
What is the purpose of this trial?
This phase II/III trial tests whether it is possible to decrease the chance of high-grade B-cell lymphomas returning or getting worse by adding a new drug, venetoclax to the usual combination of drugs used for treatment. Venetoclax may stop the growth of cancer cells by blocking a protein called Bcl-2. Drugs used in usual chemotherapy, such as rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving venetoclax together with usual chemotherapy may work better than usual chemotherapy alone in treating patients with high-grade B-cell lymphomas, and may increase the chance of cancer going into remission and not returning.
Will I have to stop taking my current medications?
The trial requires that you stop taking any strong CYP3A4 inhibitors or inducers at least 14 days before starting venetoclax. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Venetoclax combined with chemotherapy for B-cell lymphoma?
Research shows that combining Venetoclax with chemotherapy drugs like R-CHOP in patients with non-Hodgkin lymphoma, including diffuse large B-cell lymphoma, resulted in high overall response rates of 87.5% and complete response rates of around 79%. This suggests that Venetoclax can enhance the effectiveness of standard chemotherapy in treating aggressive B-cell lymphomas.12345
Is the combination of Venetoclax and chemotherapy safe for humans?
What makes the drug Venetoclax combined with chemotherapy unique for treating B-cell lymphoma?
Research Team
Jeremy S Abramson
Principal Investigator
Alliance for Clinical Trials in Oncology
Eligibility Criteria
This trial is for patients with high-grade B-cell lymphomas, including those with certain genetic markers like MYC and BCL2 translocations. It's not open to individuals who have had previous treatments for this cancer, except possibly one round of specific chemotherapy or corticosteroids. Pregnant or nursing women can't participate due to unknown risks to fetuses and newborns.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive R-CHOP or DA-EPOCH-R chemotherapy regimen with or without venetoclax for 6 cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cyclophosphamide
- Doxorubicin Hydrochloride
- Etoposide
- Prednisone
- Rituximab
- Venetoclax
- Vincristine Sulfate
Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
- Rheumatoid arthritis
- Breast cancer
- Ovarian cancer
- Multiple myeloma
- Leukemia
- Lymphoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Cancer Institute (NCI)
Lead Sponsor