Study on Glofitamab with Obinutuzumab, Venetoclax, and Lenalidomide for Treating Newly Diagnosed High Risk Mantle Cell Lymphoma
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT05861050
This clinical trial is testing a combination of drugs, including glofitamab, obinutuzumab, venetoclax, and lenalidomide, to see if they can effectively treat patients with newly diagnosed high risk mantle cell lymphoma. The study aims to determine the safety and effectiveness of this treatment combination.
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Program Overview
This study is exploring a new treatment for patients with high risk mantle cell lymphoma, a type of cancer. The treatment involves a combination of drugs: glofitamab and obinutuzumab, which are antibodies that may stop cancer cells from growing; venetoclax, which blocks a protein that helps cancer cells survive; and lenalidomide, which helps the immune system fight cancer and supports normal blood cell production. The goal is to see if this combination can kill more cancer cells in patients who have just been diagnosed with this high risk cancer.
Description
The main goal of this study is to see how well the combination of venetoclax, glofitamab, and lenalidomide works in patients with newly diagnosed high risk mantle cell lymphoma by measuring how long patients live without the cancer getting worse over 24 months.
Secondary goals include checking the safety of the treatment, how many patients respond to it, and how many achieve complete remission. The study will also look at how long the response lasts and how the treatment works in patients with specific genetic mutations.
Exploratory goals involve studying changes in immune cells and genetic features that might affect treatment response, as well as the impact of the treatment on certain side effects.
Participants will receive the study drugs orally and through IV, and will undergo various tests, including blood tests and scans, to monitor their health and the cancer's response to treatment. Follow-up visits will occur every 3 months for the first two years, then every 6 months until the cancer returns.
Eligibility Criteria
Inclusion Criteria
- Must provide informed consent to participate.
- Agree to use tissue samples from previous tumor biopsies.
- Aged between 18 and 80 years.
- Have a diagnosis of mantle cell lymphoma confirmed by specific tests.
- Show certain genetic markers associated with mantle cell lymphoma.
- Require treatment for mantle cell lymphoma and have not received prior systemic cancer treatments.
- Have high risk features such as specific genetic mutations or high tumor growth rates.
- Be able to swallow pills.
- Meet specific blood count and organ function requirements.
- Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for a specified period after.
- Must be registered in a specific safety program for one of the study drugs and comply with its requirements.
Exclusion Criteria
- Cannot take certain medications that interact with the study drugs.
- Cannot have ongoing high-dose steroid use unless stable for at least 4 weeks.
- Cannot have a history of substance abuse within the past year.
- Cannot have had a solid organ transplant requiring ongoing immunosuppression.
- Cannot have received a live vaccine recently or need one during the study.
- Cannot have allergies to similar drugs used in the study.
- Cannot have other cancers that could interfere with the study.
- Cannot have had major surgery recently.
- Cannot have certain viral infections or a history of specific immune system disorders.
- Cannot have active infections or significant heart disease.
- Cannot be pregnant or breastfeeding.
- Cannot have uncontrolled autoimmune diseases or require systemic treatment for them.
- Cannot have central nervous system lymphoma or certain neurological conditions.
- Cannot have severe liver disease or any condition that would make participation unsafe.
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