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NCT06191744 · 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 Previously Untreated Follicular Lymphoma
A Phase 3 study of Follicular Lymphoma (FL), sponsored by Genmab.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,095
- Enrollment target
- 20
- Study locations
NCT06191744: Recruiting Phase 3 study of Follicular Lymphoma (FL), sponsored by Genmab.
NCT06191744 is a Phase 3 study of Follicular Lymphoma (FL) that is actively recruiting participants, run by Genmab. The registered enrollment target is 1,095 participants, above the 423-participant average among 10 other Follicular Lymphoma (FL) trials with a reported enrollment target (159% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06191744, a Phase 3 study of Follicular Lymphoma (FL), is actively recruiting participants, sponsored by Genmab.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,095 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 previously untreated 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 5 groups, called treatment arms. Each group receives a different treatment. Around 1095 adult participants with previously untreated FL will be enrolled in approximately 250 sites across the world. Participants will receive R2 (intravenous \[IV\] infusion of rituximab (R) and oral capsules of lenalidomide) alone or in combination with subcutaneous injections of epcoritamab. Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV injections of vincristine, oral tablets of prednisone (CHOP) \[G-CHOP\]/ R-CHOP or G and IV infusion of bendamustine (Benda) \[G-Benda\]/R-Benda. The total treatment duration will be 120 weeks for all arms except A2, which is 24 weeks of treatment. 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
CR30 will be determined by positron emission tomography-computerized tomography (cat scan) \[PET-CT\] per Lugano 2014 criteria, as assessed by independent review committee (IRC).
Conditions Studied
Interventions
- DRUG Doxorubicin
- DRUG Epcoritamab
- DRUG Rituximab
- DRUG Lenalidomide
- DRUG Prednisone
Study Locations (20)
Florida
- Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 262445 - Jacksonville
- Advent Health /ID# 261578 - Orlando
- Orlando Health Cancer Institute /ID# 260983 - Orlando
- Moffitt Cancer Center /ID# 259487 - Tampa
Illinois
- Northwestern University- Robert H. Lurie Comprehensive Cancer Center /ID# 259814 - Chicago
- Cancer Care Specialists Of Central Illinois /ID# 272464 - Decatur
- Loyola University /ID# 259462 - Maywood
- Illinois Cancer Care, PC /ID# 261526 - Peoria
California
- UCSF Fresno /ID# 264712 - Fresno
- Scripps Mercy Hospital /ID# 265393 - San Diego
- Sansum Clinic Research /ID# 261596 - Santa Barbara
Kentucky
- University of Louisville Hospital /ID# 260544 - Louisville
- Norton Cancer Institute - St. Matthews /ID# 261076 - Louisville
Colorado
- Rocky Mountain Cancer Centers - Boulder /ID# 261203 - Boulder
Delaware
- Christiana Care Health Service /ID# 261207 - Newark
Idaho
- Beacon Cancer Care /ID# 260670 - Coeur d'Alene
Indiana
- Fort Wayne Medical Oncology and Hematology- South Office /ID# 259583 - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,095 participants |
| Start Date | 2024-02-05 |
| Est. Completion | 2037-11 |
| Phase | Phase 3 |
What NCT06191744 shows while recruiting
NCT06191744 is an interventional study that assigns participants to a tested intervention. Its 1,095 participants enrollment target places it among the larger protocols in the corpus, above the 423-participant average among 10 other Follicular Lymphoma (FL) trials with a reported enrollment target (159% higher).
The record links to 1 condition, with Follicular Lymphoma (FL) appearing as the primary indexed condition, and to 5 interventions - of which Doxorubicin is the first listed.
NCT06191744 names 20 study sites across 11 states, led by Florida, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT06191744 about?
NCT06191744 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 Previously Untreated 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 NCT06191744?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,095 participants. The study started on 2024-02-05. Estimated completion is 2037-11.
What conditions does trial NCT06191744 study?
This clinical trial studies the following conditions: Follicular Lymphoma (FL).
What interventions are being tested in trial NCT06191744?
The interventions under investigation include: Doxorubicin (DRUG), Epcoritamab (DRUG), Rituximab (DRUG), Lenalidomide (DRUG), Prednisone (DRUG).
Who is sponsoring clinical trial NCT06191744?
This trial is sponsored by Genmab, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06191744 being conducted?
This trial has 20 study locations across California, Colorado, Delaware, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06191744's enrollment target sits among peer trials
1,095 1st of 10 higher than 10 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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