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NCT05283720 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
A Phase 2 study of Non-Hodgkin Lymphoma, sponsored by Genmab.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 496
- Enrollment target
- 20
- Study locations
NCT05283720: Recruiting Phase 2 study of Non-Hodgkin Lymphoma, sponsored by Genmab.
NCT05283720 is a Phase 2 study of Non-Hodgkin Lymphoma that is actively recruiting participants, run by Genmab. The registered enrollment target is 496 participants, above the 163-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (204% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05283720, a Phase 2 study of Non-Hodgkin Lymphoma, is actively recruiting participants, sponsored by Genmab.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 496 participants
- Enrollment target
- 20
- Study locations
Study Summary
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymphoma (NHL). Adverse events and change in disease activity will be assessed. Epcoritamab is an investigational drug being developed for the treatment of NHL. Study doctors put the participants in groups called treatment arms. The combination of epcoritamab with anti-neoplastic agents will be explored. Each treatment arm receives a different treatment combination depending on eligibility. Approximately 496 adult participants with NHL will be enrolled in 100 sites globally. In both the dose escalation and dose expansion arms participants will receive subcutaneous (SC) epcoritamab in 28 day, 21 day, or 56 day cycles dependent on the arm in combination with the anti-neoplastic agents described below: 1: Oral lenalidomide in participants (PPTS) with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL); 2: Oral ibrutinib and oral lenalidomide in PPTS with R/R DLBCL; 3: Intravenous (IV) polatuzumab vedotin, IV rituximab, IV cyclophosphamide, IV doxorubicin hydrochloride (HCl), and oral prednisone (pola-R-CHP) in PPTS with newly diagnosed treatment-naïve DLBCL, or completion of treatment in 3B; 4: Oral CC-99282 in PPTS with R/R DLBCL; 5: Oral CC-99282 in PPTS with R/R follicular lymphoma (FL); 6A: Oral ibrutinib in PPTS with R/R mantle cell lymphoma (MCL). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Primary Outcome
DLT events are defined as clinically significant adverse events or abnormal laboratory values assessed as unrelated to disease progression, underlying disease, intercurrent illness, or concomitant medications.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Epcoritamab
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Ibrutinib
Study Locations (20)
North Carolina
- Novant Health Presbyterian Medical Center /ID# 242148 - Charlotte
- East Carolina University - Brody School of Medicine /ID# 242506 - Greenville
- Novant Health Forsyth Medical Center /ID# 242198 - Winston-Salem
New York
- Northwell Health - Monter Cancer Center /ID# 245435 - Lake Success
- Icahn School of Medicine at Mount Sinai /ID# 242123 - New York
Pennsylvania
- Thomas Jefferson University Hospital /ID# 242077 - Philadelphia
- Fox Chase Cancer Center /ID# 242106 - Philadelphia
Washington
- Swedish Medical Center - Seattle /ID# 242269 - Seattle
- MultiCare Institute for Research & Innovation /ID# 242127 - Tacoma
Arizona
- The University of Arizona Cancer Center - North Campus /ID# 242219 - Tucson
Connecticut
- Yale University School of Medicine /ID# 242089 - New Haven
Delaware
- Christiana Care Health Service /ID# 242301 - Newark
Florida
- Tampa General Hospital /ID# 246748 - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 496 participants |
| Start Date | 2022-06-14 |
| Est. Completion | 2032-11 |
| Phase | Phase 2 |
What NCT05283720 shows while recruiting
NCT05283720 is an interventional study that assigns participants to a tested intervention. The registered 496 participants enrollment target is mid-sized for trials with a published cap, above the 163-participant average among 106 other Non-Hodgkin Lymphoma trials with a reported enrollment target (204% higher).
The record links to 1 condition, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT05283720 names 20 study sites across 15 states, led by North Carolina, New York, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05283720 about?
NCT05283720 is a clinical study titled "A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma". B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections). The purpose of this study is to assess the safety and tolerability of epcoritamab in combination with anti-neoplastic agents in adult participants with Non-Hodgkin lymp...
What is the current status of trial NCT05283720?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 496 participants. The study started on 2022-06-14. Estimated completion is 2032-11.
What conditions does trial NCT05283720 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma.
What interventions are being tested in trial NCT05283720?
The interventions under investigation include: Cyclophosphamide (DRUG), Epcoritamab (DRUG), Rituximab (DRUG), Lenalidomide (DRUG), Ibrutinib (DRUG).
Who is sponsoring clinical trial NCT05283720?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05283720 being conducted?
This trial has 20 study locations across Arizona, Connecticut, Delaware, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05283720's enrollment target sits among peer trials
496 9th of 106 higher than 98 of 106 other Non-Hodgkin Lymphoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Hodgkin Lymphoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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