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Obinutuzumab + CC-99282 for Follicular Lymphoma

Phase 2

Waitlist Available

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

This trial tests a combination of drugs to see if it can stop the growth of an aggressive form of lymphoma.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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

2015

Completed Phase 3

~3250

CC-99282

2017

Completed Phase 2

~70

0 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbIndustry Sponsor

2,642 Previous Clinical Trials

4,130,087 Total Patients Enrolled

M.D. Anderson Cancer CenterLead Sponsor

2,975 Previous Clinical Trials

1,789,473 Total Patients Enrolled

Dai Chihara, M D, PhDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the combination of Obinutuzumab and CC-99282 gained regulatory approval?

"Our experts at Power judged the safety of Obinutuzumab+CC-99282 to be a 2 on their 1-3 scale, as this is just a Phase 2 trial with some evidence demonstrating security but none asserting efficacy."

Answered by AI

Is this research currently recruiting participants?

"As indicated by clinicaltrials.gov, this investigation is no longer recruiting participants; its original posting was on March 31st 2024 and the final edit to it occurred October 25th 2023. However, there are still 1,747 other trials actively enrolling individuals at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma

2024. "Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06108232.

All > Follicular Lymphoma