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Immunomodulatory Agent

Iberdomide + CC-99282 for Lymphoma

Phase 1
Recruiting
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have measurable disease defined by at least one FDG-avid lesion for FDG-avid subtype and one bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification (Cheson, 2014).
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L or ≥ 1.0 x 109/L in case of documented bone marrow involvement (> 50% or tumor cells), without growth factor support for 7 days (14 days if peg-G-CSF).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years
Awards & highlights

Study Summary

This trial is testing two new drugs, CC-220 and CC-99282, to see if they are effective in treating a-BCL (a type of cancer). The trial has two parts: first, a dose escalation to find the best dose of the new drugs to use, and second, a randomized expansion to test the new drugs at the recommended dose.

Who is the study for?
Adults over 18 with a specific type of untreated lymphoma (a-BCL) can join this trial. They must have certain blood and organ function levels, no serious health issues, and agree to pregnancy prevention measures if applicable. People with other lymphoma types, CNS involvement by lymphoma, significant medical conditions or infections like COVID-19, recent major surgery, inability to swallow tablets, HIV or active hepatitis B/C are excluded.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of two drugs (Iberdomide [CC-220] and CC-99282) combined with R-CHOP chemotherapy in treating lymphoma. It has two parts: first determining safe doses (dose escalation), then giving these doses to more people to see how well they work (dose expansion).See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system's response to the drugs which could affect various organs; blood disorders; digestive issues; fatigue; increased risk of infection due to lowered immunity; nerve damage that might cause numbness or tingling.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be measured and seen on a scan.
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My white blood cell count is within the required range.
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I have a new, untreated type of aggressive B-cell lymphoma.
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My kidneys work well enough, with a creatinine clearance of 50 mL/min or more.
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I am able to care for myself and perform daily activities.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 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 (MTD) - Part 1
Maximum Tolerated Dose (MTD) - Part 2A
Recommended Phase 2 Dose (RP2D) - Part 1
+2 more
Secondary outcome measures
Best overall response rate (ORR)
Complete Metabolic Response Rate (CMRR)
Duration of Response (DOR)
+9 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Administration of CC-99282 with polatuzumab-R-CHPExperimental Treatment6 Interventions
CC-99282 to be administered orally in combination with Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (polatuzumab-R-CHP) for 6 cycles of treatment
Group II: Administration of CC-99282 with R-CHOP-21Experimental Treatment6 Interventions
CC-99282 to be administered orally in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP-21) for 6 cycles of treatment
Group III: Administration of CC-220 with polatuzumab-R-CHPExperimental Treatment6 Interventions
CC-220 to be administered orally in combination with Polatuzumab vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (polatuzumab-R-CHP) for 6 cycles of treatment
Group IV: Administration of CC-220 with R-CHOP-21Experimental Treatment6 Interventions
CC-220 to be administered orally in combination with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (R-CHOP-21) for 6 cycles of treatment
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Doxorubicin
2012
Completed Phase 3
~7940
Vincristine
2003
Completed Phase 4
~2910
CC-220
2016
Completed Phase 2
~620
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3770
Prednisone
2014
Completed Phase 4
~2370
CC-99282
2017
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,797 Total Patients Enrolled
Vijaya Kesanakurthy, MDStudy DirectorCelgene Corporation
1 Previous Clinical Trials
47 Total Patients Enrolled
Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb
1,507 Previous Clinical Trials
3,369,823 Total Patients Enrolled

Media Library

CC-220 (Immunomodulatory Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04884035 — Phase 1
B-Cell Lymphoma Research Study Groups: Administration of CC-220 with R-CHOP-21, Administration of CC-220 with polatuzumab-R-CHP, Administration of CC-99282 with polatuzumab-R-CHP, Administration of CC-99282 with R-CHOP-21
B-Cell Lymphoma Clinical Trial 2023: CC-220 Highlights & Side Effects. Trial Name: NCT04884035 — Phase 1
CC-220 (Immunomodulatory Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04884035 — Phase 1

Frequently Asked Questions

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

Are there various facilities in the United States that are facilitating this clinical study?

"This medical trial has been approved to operate out of the Mayo Clinic Jacksonville - PPDS in Jacksonville, Florida, Mayo Clinic Rochester in Minnesota and Vanderbilt University Medical Center in Tennessee. Additionally, there are 10 more sites across America authorized for recruitment."

Answered by AI

Are there any recruitment opportunities for this medical experiment?

"Clinicaltrials.gov provides evidence that this clinical trial is still in search of participants, having been initially published on September 15th 2021 and last updated October 11th 2022."

Answered by AI

Is there a documented history of research with Rituximab?

"Since 1993, there have been 2583 studies conducted on the efficacy of rituximab from National Institutes of Health Clinical Center in Rockville Pike. Presently, 1478 trials are still ongoing with many based out of Jacksonville, Florida."

Answered by AI

What goals is the trial attempting to attain?

"According to Celgene, the primary objective of this clinical trial will be measured in a 21-day time period and is focused on safety and tolerance for CC-220 and CC-99282. Aside from the main aim, researchers are assessing other pharmacokinetic parameters such as Area under the plasma concentration-time curve (AUC), Time to maximum plasma concentration (Tmax) and Apparent volume of distribution (V/F)."

Answered by AI

What impact does Rituximab have on a person's overall health?

"As it is a Phase 1 clinical trial, our team at Power rates Rituximab's safety as low (1), due to limited evidence of its effectiveness and safety."

Answered by AI

What is the current enrollment size for this investigation?

"Celgene, the sponsor of this trial, needs 116 qualified participants to proceed. The study will be conducted in both Mayo Clinic Jacksonville - PPDS situated in Jacksonville, Florida and Mayo Clinic Rochester located in Minnesota's largest city."

Answered by AI

How is Rituximab usually deployed to treat patients?

"Rituximab is widely used to treat ulcerative colitis and has also been shown to be effective in the management of conditions like acute retinal necrosis due to varicella-zoster virus, multiple myeloma, and tuberculous meningitis."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
2021. "Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04884035.
~5 spots leftby Jun 2024
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