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NCT05409066 · ClinicalTrials.gov registry record · Phase 3
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
A Phase 3 study of Follicular Lymphoma (FL), sponsored by Genmab.
- Active
- Registry status
- Phase 3
- Development phase
- 549
- Enrollment target
- 20
- Study locations
NCT05409066: Active Phase 3 study of Follicular Lymphoma (FL), sponsored by Genmab.
NCT05409066 is a Phase 3 study of Follicular Lymphoma (FL) that is active but no longer recruiting, run by Genmab. The registered enrollment target is 549 participants, above the 477-participant average among 10 other Follicular Lymphoma (FL) trials with a reported enrollment target (15% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05409066, a Phase 3 study of Follicular Lymphoma (FL), is active but no longer recruiting, sponsored by Genmab.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 549 participants
- Enrollment target
- 20
- Study locations
Study Summary
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m\^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). 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 a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Primary Outcome
BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC.
Conditions Studied
Interventions
- DRUG Epcoritamab
- DRUG Rituximab
- DRUG Lenalidomide
Study Locations (20)
California
- Alta Bates Summit Medical Center for Research /ID# 229428 - Berkeley
- Beverly Hills Cancer Center /ID# 231535 - Beverly Hills
- Long Beach Memorial Medical Ct /ID# 228997 - Long Beach
- University of Southern California /ID# 227195 - Los Angeles
- Valkyrie Clinical Trials /ID# 268502 - Los Angeles
Indiana
- Goshen Center for Cancer Care /ID# 227189 - Goshen
- Community Health Network, Inc. /ID# 259756 - Indianapolis
Massachusetts
- Massachusetts General Hospital /ID# 245233 - Boston
- UMass Memorial Medical Center /ID# 227323 - Worcester
Arizona
- The University of Arizona Cancer Center - North Campus /ID# 228862 - Tucson
Arkansas
- University of Arkansas for Medical Sciences /ID# 227198 - Little Rock
Georgia
- Duplicate_Emory University /ID# 227299 - Atlanta
Hawaii
- Hawaii Cancer Care - Waterfront Plaza /ID# 262448 - Honolulu
Illinois
- Northwestern University Feinberg School of Medicine /ID# 227248 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 549 participants |
| Start Date | 2022-09-20 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
What the registry record for NCT05409066 still lists
NCT05409066 is an interventional study that assigns participants to a tested intervention. The registered 549 participants enrollment target is mid-sized for trials with a published cap, above the 477-participant average among 10 other Follicular Lymphoma (FL) trials with a reported enrollment target (15% higher).
The record links to 1 condition, with Follicular Lymphoma (FL) appearing as the primary indexed condition, and to 3 interventions - of which Epcoritamab is the first listed.
NCT05409066 names 20 study sites across 14 states, led by California, Indiana, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05409066 about?
NCT05409066 is a clinical study titled "Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma". Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in comb...
What is the current status of trial NCT05409066?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 549 participants. The study started on 2022-09-20. Estimated completion is 2029-12.
What conditions does trial NCT05409066 study?
This clinical trial studies the following conditions: Follicular Lymphoma (FL).
What interventions are being tested in trial NCT05409066?
The interventions under investigation include: Epcoritamab (DRUG), Rituximab (DRUG), Lenalidomide (DRUG).
Who is sponsoring clinical trial NCT05409066?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05409066 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Georgia, Hawaii. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Follicular Lymphoma (FL)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05409066's enrollment target sits among peer trials
549 6th of 10 higher than 5 of 10 other Follicular Lymphoma (FL) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Follicular Lymphoma (FL) 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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