Triple Drug Therapy for Follicular Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the combined power of three drugs—obinutuzumab, ibrutinib, and venetoclax—to treat individuals with untreated stage II-IV follicular lymphoma. The goal is to determine if using these drugs together can more effectively halt cancer growth compared to using them individually. Participants with follicular lymphoma and symptoms such as large lymph nodes or weight loss are sought. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on a strong CYP3A4 inhibitor, you may need to stop it before starting the trial.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of obinutuzumab, ibrutinib, and venetoclax has been safe in earlier studies with cancers like chronic lymphocytic leukemia (CLL) and mantle cell lymphoma. These studies found that participants generally tolerated the combination well.
Obinutuzumab is already approved for treating certain cases of relapsed or hard-to-treat follicular lymphoma, indicating a known safety record for this condition.
The combination of ibrutinib and venetoclax has also demonstrated promising safety and effectiveness in other cancers. While some side effects may occur, as with any treatment, the evidence so far supports the safety of using these drugs together.12345Why are researchers excited about this trial's treatments?
Unlike the standard chemotherapy regimens for follicular lymphoma, this triple drug therapy combines ibrutinib, obinutuzumab, and venetoclax, each targeting the cancer cells in a unique way. Ibrutinib works by blocking a specific protein involved in the growth of cancer cells. Obinutuzumab is an antibody that targets and helps destroy lymphoma cells, while venetoclax disrupts the cells' ability to survive. Researchers are excited about this combination because together, these drugs may offer a more precise attack on lymphoma, potentially leading to better outcomes and fewer side effects compared to traditional treatments.
What evidence suggests that this triple drug therapy might be an effective treatment for follicular lymphoma?
Research shows that using the drugs obinutuzumab, ibrutinib, and venetoclax together may effectively treat follicular lymphoma. In this trial, participants will receive this combination therapy. One study found that this combination helped newly diagnosed patients control the disease well, with 80% not experiencing disease progression after five years. Another study found that using obinutuzumab and venetoclax together significantly boosts their ability to fight tumors compared to using each drug alone. Additionally, the combination of ibrutinib and venetoclax has been manageable for patients who have had previous treatments for follicular lymphoma. These findings suggest that using these drugs together could be more effective than using them individually for this type of lymphoma.12678
Who Is on the Research Team?
Joseph M. Tuscano
Principal Investigator
University of California, Davis
Are You a Good Fit for This Trial?
This trial is for adults with previously untreated stage II-IV follicular lymphoma. Participants must have measurable disease, not be pregnant or breastfeeding, and agree to use reliable contraception. They should not have severe illnesses that could interfere with the study, known HIV or hepatitis infections, significant heart conditions, or a history of certain other malignancies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive obinutuzumab, venetoclax, and ibrutinib. Obinutuzumab is administered intravenously on specific days across 24 cycles, while venetoclax and ibrutinib are taken orally daily.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
What Are the Treatments Tested in This Trial?
Interventions
- Ibrutinib
- Obinutuzumab
- Venetoclax
Ibrutinib is already approved in European Union, United States, Canada, Japan for the following indications:
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia/small lymphocytic lymphoma
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Graft-versus-host disease
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
- Marginal zone lymphoma
- Chronic lymphocytic leukemia
- Mantle cell lymphoma
- Waldenström's macroglobulinemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
Joseph Tuscano
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Pharmacyclics LLC.
Industry Sponsor
Dr. Maky Zanganeh
Pharmacyclics LLC.
Chief Executive Officer
Degree from Louis Pasteur University in Strasbourg, France; MBA from Schiller International University in France
Dr. Ellie Im
Pharmacyclics LLC.
Chief Medical Officer
MD from an unspecified institution
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD