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Monoclonal Antibodies

Treatment (rituximab, CC-99282) for Lymphoma

Phase 1

Recruiting

Led By Nathan Denlinger, DO, MS

Research Sponsored by Nathan Denlinger

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Eastern Cooperative Oncology Group (ECOG) Score = 0-2

Evidence of sub-optimal response to CD19.CAR-T as defined in this trial by Deauville Score ≥ 3 on PET/CT at 30 days post CART infusion (+15/-5 days)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of a combination of CC-99282 and rituximab for the treatment of patients with non-Hodgkin's lymphoma who have not responded well

Who is the study for?

This trial is for patients with various types of Non-Hodgkin's Lymphoma who have had a less than ideal response to CAR T-cell therapy. It's important that participants haven't responded well to this prior treatment and are now looking for additional options.Check my eligibility

What is being tested?

The trial is testing the combination of a new immunotherapy drug, CC-99282, with an established cancer drug called Rituximab. The study aims to find the safest dose and observe how these drugs affect the immune system in attacking lymphoma cells post CAR-T therapy.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system such as fever or fatigue, issues where CC-99282 is injected, and possible complications from Rituximab like infections or heart problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am able to care for myself and perform daily activities.

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My cancer did not respond well to a specific immune therapy, as shown by a special scan.

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My kidney function, measured by eGFR, is sufficient for the study.

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I agree to follow strict birth control or abstinence guidelines while on CC-99282 treatment.

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I have been diagnosed with a type of B-cell Non-Hodgkin's lymphoma.

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I can swallow and absorb pills.

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I have previously received a specific CAR-T cell therapy for my condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum tolerated dose

Secondary outcome measures

Freedom from progression

Incidence of adverse events

Number of patients with response to treatment as assessed by CT imaging

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (rituximab, CC-99282)Experimental Treatment6 Interventions

Patients receive rituximab IV on day 1 of each cycle and CC-99282 PO QD on days 1-14 of each cycle. Treatment repeats every 28 days for up to 6 cycles of rituximab and up to 24 cycles of CC-99282 in the absence of disease progression or unacceptable toxicity. Patients also undergo PET/CT and collection of blood samples throughout the trial. Patients may undergo biopsy at screening.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biopsy

2014

Completed Phase 4

~1090

Positron Emission Tomography

2008

Completed Phase 2

~2240

Biospecimen Collection

2004

Completed Phase 2

~1700

Computed Tomography

2017

Completed Phase 2

~2720

Rituximab

1999

Completed Phase 4

~1880

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nathan DenlingerLead Sponsor

Bristol-Myers SquibbIndustry Sponsor

2,641 Previous Clinical Trials

4,130,046 Total Patients Enrolled

61 Trials studying Lymphoma

6,573 Patients Enrolled for Lymphoma

Nathan Denlinger, DO, MSPrincipal InvestigatorOhio State University Comprehensive 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 treatment of rituximab and CC-99282 received official approval from the FDA?

"Since this is a Phase 1 trial, the safety of Treatment (rituximab, CC-99282) is estimated to be at level 1. This indicates that there is limited data available to support its safety and efficacy."

Answered by AI

Are there any available vacancies for potential participants in this research study?

"As per the current information provided by clinicaltrials.gov, this particular study is not currently seeking participants. The trial was initially posted on January 21st, 2024 and last updated on January 8th, 2024. However, it's worth noting that there are presently 2559 other ongoing studies actively recruiting participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma

Nathan Denlinger 2024. "CC-99282 + Rituximab Early Post CART for Non-Hodgkin's Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06209619.

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