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Protein Kinase Inhibitor

Epcoritamab Combo for Non-Hodgkin's Lymphoma

Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
DLBCL, not otherwise specified (NOS).
Diagnosis of Diffuse large B-cell lymphoma (DLBCL) (de novo or histologically transformed from follicular lymphoma (FL) or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to World Health Organization (WHO) 2016 classification and documented in pathology report:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights

Study Summary

This trial is assessing the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Approximately 132 adult participants with NHL will be enrolled in 100 sites globally.

Who is the study for?
Adults with Non-Hodgkin lymphoma (NHL) including various subtypes like diffuse large B-cell lymphoma and mantle cell lymphoma. Participants must have a certain level of physical fitness, measurable disease sites, and no unresolved toxicities from previous cancer therapies above a mild grade, except for hair loss.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of Epcoritamab when combined with other anti-cancer drugs in treating NHL. Patients are grouped to receive different combinations based on their specific type of NHL, either as new patients or those who've relapsed after prior treatments.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site due to Epcoritamab being given under the skin, plus typical chemotherapy-related effects such as nausea, fatigue, blood disorders, increased infection risk and possible organ inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition is diagnosed as DLBCL, not otherwise specified.
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I have been diagnosed with a specific type of lymphoma (DLBCL) that tests positive for CD20.
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My condition is Grade 3B Follicular Lymphoma.
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My lymphoma is classified as 'double-hit' or 'triple-hit' according to WHO 2016.
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My follicular lymphoma is CD20+ Grade 1-3a without turning aggressive.
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I have a tumor that can be measured on a scan.
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I can care for myself but may not be able to do heavy physical work.
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My lymphoma is CD20+ and shows specific genetic features.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 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
Number of Participants with Dose-Limiting Toxicities (DLT)
Secondary outcome measures
Best Overall Response (BOR) per Investigator
Duration of response (DOR) per Investigator
Number of Participants with Progression-free survival (PFS)
+5 more

Trial Design

15Treatment groups
Experimental Treatment
Group I: Arm 7: Dose ExpansionExperimental Treatment2 Interventions
Participants with newly diagnosed treatment-naïve MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Group II: Arm 7: Dose EscalationExperimental Treatment1 Intervention
Participants with newly diagnosed treatment-naïve MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Group III: Arm 6B: Dose EscalationExperimental Treatment3 Interventions
Participants with R/R MCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib, and oral venetoclax in 28 day cycles.
Group IV: Arm 6A: Dose EscalationExperimental Treatment2 Interventions
Participants with R/R mantle cell lymphoma (MCL) will receive escalating doses of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
Group V: Arm 6: Dose ExpansionExperimental Treatment2 Interventions
Participants with R/R MCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib in 28 day cycles.
Group VI: Arm 5: Dose ExpansionExperimental Treatment1 Intervention
Participants with R/R FL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Group VII: Arm 5: Dose EscalationExperimental Treatment2 Interventions
Participants with R/R follicular lymphoma (FL) will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Group VIII: Arm 4: Dose ExpansionExperimental Treatment1 Intervention
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Group IX: Arm 4: Dose EscalationExperimental Treatment2 Interventions
Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral CC-99282 in 28 day cycles.
Group X: Arm 3: Dose ExpansionExperimental Treatment6 Interventions
Participants newly diagnosed treatment-naïve DLBCL will receive the recommended dose of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.
Group XI: Arm 3: Dose EscalationExperimental Treatment6 Interventions
Participants with newly diagnosed treatment-naïve DLBCL will receive escalating doses of SC epcoritamab in combination with intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in 21 day cycles.
Group XII: Arm 2: Dose ExpansionExperimental Treatment3 Interventions
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Group XIII: Arm 2: Dose EscalationExperimental Treatment3 Interventions
Participants with R/R DLBCL will receive escalating doses of SC epcoritamab in combination with oral ibrutinib and oral lenalidomide in 28 day cycles.
Group XIV: Arm 1: Dose ExpansionExperimental Treatment2 Interventions
Participants with R/R DLBCL will receive the recommended dose of SC epcoritamab in combination with oral lenalidomide in 28 day cycles.
Group XV: Arm 1: Dose EscalationExperimental Treatment2 Interventions
Participants with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) will receive escalating doses of subcutaneous (SC) epcoritamab in combination with oral lenalidomide in 28 day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Polatuzumab Vedotin
2019
Completed Phase 2
~820
Venetoclax
2019
Completed Phase 3
~1990
CC-99282
2017
Completed Phase 2
~70
Lenalidomide
2005
Completed Phase 3
~1480
Ibrutinib
2014
Completed Phase 3
~1880
Rituximab
1999
Completed Phase 4
~1880
Cyclophosphamide
1995
Completed Phase 3
~3780
Prednisone
2014
Completed Phase 4
~2370

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
950 Previous Clinical Trials
496,534 Total Patients Enrolled
GenmabIndustry Sponsor
56 Previous Clinical Trials
11,838 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
390 Previous Clinical Trials
141,325 Total Patients Enrolled

Media Library

CC-99282 (Protein Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05283720 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Arm 3: Dose Expansion, Arm 6: Dose Expansion, Arm 4: Dose Escalation, Arm 5: Dose Expansion, Arm 1: Dose Escalation, Arm 5: Dose Escalation, Arm 6A: Dose Escalation, Arm 6B: Dose Escalation, Arm 7: Dose Escalation, Arm 4: Dose Expansion, Arm 7: Dose Expansion, Arm 2: Dose Escalation, Arm 3: Dose Escalation, Arm 1: Dose Expansion, Arm 2: Dose Expansion
Non-Hodgkin's Lymphoma Clinical Trial 2023: CC-99282 Highlights & Side Effects. Trial Name: NCT05283720 — Phase 2
CC-99282 (Protein Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05283720 — Phase 2

Frequently Asked Questions

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

Does Epcoritamab have a lot of harmful side effects?

"Because this is a Phase 2 trial, meaning that while there is some safety data, there is no efficacy data, our team at Power has given Epcoritamab a score of 2."

Answered by AI

How many locations are conducting this research project?

"Currently, this trial has 29 enrolling patients at locations such as Roswell Park Comprehensive Cancer Center /ID# 242129 in Buffalo, Johns Hopkins University /ID# 242193 in Baltimore, and Memorial Sloan Kettering Cancer Center-Koch Center /ID# 242305 in New york.This question is asking for your opinion:Answer: I believe that the safety of psilocybin should be rated a 3 on Power's scale.Rewritten Answer: In my estimation, the team at Power was right to rate the safety of psilocybin as a 3."

Answered by AI

How many people will be included in this experiment at most?

"Indeed, the listing on clinicaltrials.gov verifies that this trial is looking for more patients. The study was first posted on June 14th, 2022 and updated most recently on November 9th, 2022. They are hoping to enroll 132 people total from 29 different sites."

Answered by AI

Are there any available slots for participants in this trial?

"Correct. The information available on clinicaltrials.gov affirms that this trial is presently looking for volunteers. This study was originally advertised on 6/14/2022, with the most recent update being 11/9/2022. In total, 132 patients are needed across 29 different sites."

Answered by AI
~263 spots leftby Nov 2032