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RECRUITING 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

NCT06191744 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 1,095 participants
Start Date 2024-02-05
Est. Completion 2037-11
Phase Phase 3

Sponsor

Genmab

59 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06191744

The ClinicalTrials.gov registry entry for NCT06191744 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,095 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genmab, which has 59 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06191744 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Illinois, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06191744?

The interventions under investigation include: Doxorubicin (DRUG), Epcoritamab (DRUG), Rituximab (DRUG), Lenalidomide (DRUG), Prednisone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06191744?

This trial is sponsored by Genmab, which has 59 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial