What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Follicular Lymphoma include monoclonal antibodies like Obinutuzumab and Rituximab, as well as newer agents like CC-99282. Obinutuzumab, a CD20-targeting monoclonal antibody, can cause infusion-related reactions, neutropenia, thrombocytopenia, and infections. CC-99282, a Cereblon E3 ligase modulator, is still under investigation, but similar agents often cause cytopenias, gastrointestinal disturbances, and fatigue. These treatments aim to target cancer cells specifically, but they can also affect normal cells, leading to the aforementioned side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for Follicular Lymphoma that are similar to the ones being studied in the trial involving Obinutuzumab and CC-99282. Obinutuzumab, a monoclonal antibody targeting CD20, has been approved for use in combination with chemotherapy for previously untreated Follicular Lymphoma and as maintenance therapy for patients who respond to treatment. Other CD20-targeting monoclonal antibodies approved for Follicular Lymphoma include Rituximab and Ofatumumab. While specific approvals for Cereblon E3 ligase modulators like CC-99282 in Follicular Lymphoma are not detailed, the combination of targeted therapies and monoclonal antibodies represents a significant advancement in treatment options.

What other types of research exist?

Promising alternatives for Follicular Lymphoma treatment include: 1) Tositumomab and Iodine 131 tositumomab (Bexxar) and Ibritumomab tiuxetan (Zevalin), which are radioimmunoconjugates with high response rates in relapsed B-cell non-Hodgkin's lymphoma. 2) Inotuzumab ozogamicin, a CD22-specific immunoconjugate, which has shown significant anti-tumor activity. 3) Bendamustine combined with Rituximab, which has demonstrated high response rates and prolonged progression-free survival in various studies.

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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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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

0 / 20Eligibility criteria met

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.