Obinutuzumab + Ibrutinib for Indolent Non-Hodgkin's Lymphomas
Trial Summary
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot use warfarin, other vitamin K antagonists, or strong CYP3A inhibitors. You should also be off corticosteroids 2 weeks before starting the trial.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are using warfarin, other vitamin K antagonists, or require treatment with a strong CYP3A inhibitor. You should also be off corticosteroids for 2 weeks before joining the study.
What data supports the idea that Obinutuzumab + Ibrutinib for Indolent Non-Hodgkin's Lymphomas is an effective treatment?
The available research does not provide specific data on the combination of Obinutuzumab and Ibrutinib for Indolent Non-Hodgkin's Lymphomas. However, it does mention that Ibrutinib, when combined with another drug called Rituximab, showed positive results in treating a similar condition called follicular lymphoma. In this study, a high percentage of patients responded well to the treatment, with many experiencing complete responses. This suggests that Ibrutinib can be effective in treating certain types of lymphomas, but there is no direct data on its combination with Obinutuzumab for Indolent Non-Hodgkin's Lymphomas in the provided information.12345
What data supports the effectiveness of the drug combination of Obinutuzumab and Ibrutinib for Indolent Non-Hodgkin's Lymphomas?
Research shows that Ibrutinib, when combined with another similar drug, Rituximab, was effective in treating follicular lymphoma, a type of non-Hodgkin's lymphoma, with high response rates and good survival outcomes. Additionally, Obinutuzumab has been approved for use in chronic lymphocytic leukemia, indicating its potential effectiveness in related conditions.12345
What safety data exists for the treatment of Obinutuzumab and Ibrutinib in indolent non-Hodgkin's lymphomas?
Existing safety data for Obinutuzumab and Ibrutinib in indolent non-Hodgkin's lymphomas includes findings from several studies. Obinutuzumab, when used in combination with bendamustine, showed a generally manageable tolerability profile with mild to moderate infusion-related reactions and neutropenia as common adverse events. In the GAUDI study, Obinutuzumab combined with chemotherapy (G-CHOP or G-FC) resulted in high response rates and an acceptable safety profile, with infusion-related reactions and neutropenia being the most common adverse events. Ibrutinib, when studied in combination with nivolumab, was assessed for safety in relapsed or refractory B-cell malignancies, indicating ongoing evaluation of its safety profile in combination therapies.23678
Is the combination of Obinutuzumab and Ibrutinib generally safe for humans?
Obinutuzumab and Ibrutinib have been studied for safety in various conditions. Obinutuzumab is generally well-tolerated, with mild to moderate infusion-related reactions being common, and neutropenia (low white blood cell count) as a more serious side effect. Ibrutinib has been tested in combination with other drugs and is considered safe, but specific safety data for the combination of Obinutuzumab and Ibrutinib is limited.23678
Is the drug combination of Obinutuzumab and Ibrutinib promising for treating indolent non-Hodgkin's lymphomas?
Yes, the drug combination of Obinutuzumab and Ibrutinib is promising for treating indolent non-Hodgkin's lymphomas. Obinutuzumab has shown to significantly extend the time patients live without the disease getting worse, especially in those who did not respond well to previous treatments. This makes it a valuable option for patients with this type of lymphoma.236910
How is the drug combination of Obinutuzumab and Ibrutinib unique for treating indolent non-Hodgkin's lymphomas?
The combination of Obinutuzumab and Ibrutinib is unique because Obinutuzumab is a specially engineered antibody that targets CD20 on cancer cells, while Ibrutinib blocks a protein that helps cancer cells grow. This dual approach may offer a new option for patients who have not responded to other treatments.236910
What is the purpose of this trial?
This phase II trial studies how well obinutuzumab and ibrutinib work as front line therapy in treating patients with indolent non-Hodgkin's lymphoma. Monoclonal antibodies, such as obinutuzumab, may interfere with the ability of cancer cells to grow and spread. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving obinutuzumab and ibrutinib may work better in treating patients with non-Hodgkin's lymphomas.
Research Team
Ubaldo Martinez-Outschoorn, MD
Principal Investigator
Sidney Kimmel Cancer Center at Thomas Jefferson University
Eligibility Criteria
This trial is for adults with untreated indolent non-Hodgkin's lymphoma, including various types of marginal zone and follicular lymphomas. Participants must have measurable disease, be able to swallow pills, and not have severe liver failure or other serious health conditions. Women of childbearing potential need a negative pregnancy test and agree to use effective contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ibrutinib orally once daily and obinutuzumab intravenously on specified days, repeating every 28 days for up to 6 cycles
Maintenance
Participants with stable disease continue to receive obinutuzumab every 2 months for a total of 12 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment completion
Treatment Details
Interventions
- Ibrutinib
- Obinutuzumab
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?
Sidney Kimmel Cancer Center at Thomas Jefferson University
Lead Sponsor
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
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