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Monoclonal Antibodies
Combination Therapy for Mantle Cell Lymphoma
Phase 1 & 2
Recruiting
Led By Tycel J Phillips
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up until 30 days after last dose of study drug
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a combo of drugs to treat mantle cell lymphoma, to stop cancer growth & help the immune system kill cancer cells.
Who is the study for?
This trial is for adults aged 18-80 with newly diagnosed, high-risk mantle cell lymphoma who haven't had cancer treatment before. Participants must be able to swallow pills, have certain blood counts and organ function levels, and agree to use effective birth control. People can't join if they've used certain drugs recently, have a history of other cancers or significant heart disease, active infections including hepatitis B/C or HIV, are pregnant/breastfeeding, or have CNS lymphoma.
What is being tested?
The trial tests the combination of glofitamab (a monoclonal antibody), venetoclax (BCL-2 inhibitor), and lenalidomide in treating high-risk mantle cell lymphoma. It aims to see if this drug combo is safe and more effective than current treatments by stopping cancer cells from growing.
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to monoclonal antibodies like glofitamab and obinutuzumab; low blood counts due to bone marrow suppression; digestive issues from lenalidomide; fatigue; increased risk of infection; liver problems; and possible allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline up until 30 days after last dose of study drug
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up until 30 days after last dose of study drug
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Incidence of dose limiting toxicity
Secondary study objectives
Best overall response
Incidence of adverse events of special interest
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (venetoclax, glofitamab, lenalidomide)Experimental Treatment9 Interventions
Patients receive venetoclax PO, obinutuzumab IV, glofitamab IV, and lenalidomide IV on study. Patients undergo bone marrow biopsy, blood sample collection, and CT scan and/or PET scan throughout the study. Patients may undergo tumor biopsy throughout the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2014
Completed Phase 3
~3470
Glofitamab
2021
Completed Phase 1
~60
Lenalidomide
2005
Completed Phase 3
~2240
Computed Tomography
2017
Completed Phase 2
~2740
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Biopsy
2014
Completed Phase 4
~1090
Biospecimen Collection
2004
Completed Phase 3
~2020
Positron Emission Tomography
2011
Completed Phase 2
~2200
Venetoclax
2019
Completed Phase 3
~2200
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,920 Previous Clinical Trials
41,017,066 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,530 Total Patients Enrolled
Tycel J PhillipsPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diagnosis of mantle cell lymphoma (MCL) is confirmed through specific tests.I have not eaten grapefruit, Seville oranges, or star fruit in the last 3 days.I am between 18 and 80 years old.I am currently taking warfarin.I am taking more than 30 mg/day of prednisone or its equivalent.I can perform all my self-care but cannot work.My blood clotting time is normal or managed if I'm on blood thinners.I need treatment for Mantle Cell Lymphoma and haven't had any cancer treatments before.I have no other cancers that could interfere with this study.I have an autoimmune disease that is not under control and requires treatment.I haven't taken drugs that weaken my immune system recently.I haven't taken strong medication that affects liver enzymes recently.My tests or symptoms indicate I have mantle cell lymphoma (MCL).I can swallow pills.My kidneys are functioning well, as shown by tests.My blood clotting time is normal or managed if I'm on blood thinners.I agree to use birth control or not have sex during and up to 4 months after treatment.I agree to follow the pregnancy testing schedule as required.I have serious heart problems.I have a history of certain autoimmune diseases or have been on immunosuppressive therapy recently.I have a specific type of cancer and feel no symptoms.I've had local radiotherapy of no more than 20 Gy at least 2 weeks before starting the study treatment.I do not have any current infections and haven't had a major infection in the last 4 weeks.I might have tuberculosis.I have or had lymphoma in my brain or spinal cord.I haven't had any live-virus vaccines in the last 28 days and won't need any during the study.I had an organ transplant within the last 5 years and am on immunosuppressants.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (venetoclax, glofitamab, lenalidomide)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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