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Obinutuzumab + CC-99282 for Follicular Lymphoma
Phase 2
Recruiting
Led By Dai Chihara, M D, PhD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Bulky disease is defined as > 10 cm in its greater diameter
Stage II, III or IV disease
Must not have
Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection and SARS-CoV2
Known active central nervous system lymphoma or leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of two drugs, obinutuzumab and CC-99282, to treat patients with untreated, high tumor burden follicular lymphoma. Obinutuzumab helps the immune system identify cancer cells, while CC-99282 enhances the immune response to destroy these cells. The goal is to see if this combination can effectively control the cancer and improve patient outcomes.
Who is the study for?
This trial is for adults with previously untreated, high tumor burden follicular lymphoma. Participants must have certain blood count levels, no prior cancer treatments, and be in a specific disease stage. They should not be pregnant or breastfeeding and must agree to contraception measures.
What is being tested?
The study tests the effectiveness of obinutuzumab combined with CC-99282 in controlling high tumor burden follicular lymphoma that hasn't been treated before. It's a Phase 2 trial focusing on these two drugs' impact on this type of lymphoma.
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to obinutuzumab, as well as any risks associated with new drug CC-99282 which could range from mild symptoms like nausea to more serious conditions affecting organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor is larger than 10 cm in its biggest size.
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My condition is at stage II, III, or IV.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I have a tumor larger than 7 cm outside of my spleen.
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I have at least 3 large tumors that are 3 cm or bigger.
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My spleen is enlarged or causing symptoms.
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My cancer is near or affecting my organs like kidneys, eyes, or digestive system.
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My lymphoma has caused a decrease in my blood cell counts.
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I have a cancerous lesion that is large enough to be measured accurately.
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My kidneys are functioning well, with a creatinine clearance over 50 ml/min.
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I have experienced symptoms like fever, weight loss, or night sweats.
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I have had a fever over 38℃, night sweats, and lost more than 10% of my weight in the past 6 months.
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I have fluid buildup in my chest or abdomen.
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My lymphoma is confirmed to be follicular grade 1-3a.
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I have not received any systemic treatment for lymphoma.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled HIV, Hepatitis B or C, or any significant active infection.
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I have active brain or spinal cord lymphoma.
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My cervical cancer was treated successfully and shows no signs of returning.
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My skin cancer was treated successfully and shows no signs of returning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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: Obinutuzumab+CC-99282Experimental Treatment2 Interventions
Participants will receive obinutuzumab and CC-99282 together for up to 12 study cycles. Each study cycle is 28 days.
Participants will first receive the study drugs for Cycles 1-6. Then after participants complete Cycle 6, the study doctor will decide based on the status of the disease if participant will continue to receive the study drugs for Cycles 7-12 or if participant will stop receiving them.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obinutuzumab
2014
Completed Phase 3
~3470
CC-99282
2020
Completed Phase 2
~80
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Follicular Lymphoma (FL) include targeted therapies like Obinutuzumab and CC-99282. Obinutuzumab is a monoclonal antibody that targets the CD20 protein on B-cells, leading to their destruction through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
CC-99282 is a Cereblon E3 ligase modulator that promotes the degradation of proteins essential for cancer cell survival and proliferation. These targeted mechanisms are significant for FL patients as they aim to selectively eliminate malignant B-cells, potentially offering more effective and less toxic treatment options.
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Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,695 Previous Clinical Trials
4,098,427 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,071 Previous Clinical Trials
1,803,194 Total Patients Enrolled
Dai Chihara, M D, PhDPrincipal InvestigatorM.D. Anderson Cancer Center