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New treatment option for Follicular Lymphoma (FL)
Official title 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
ClinicalTrials.gov ID: NCT06191744
What this study is testing
What is Epcoritamab?
Epcoritamab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for follicular lymphoma (fl).
Also referred to as ABBV-GMAB-3013, GEN3013.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of follicular lymphoma (FL).
- Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology...
- Are willing and able to comply with procedures required in the protocol.
- Must have stage, III, IV or II with bulky disease \>= 7cm).
- Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF)...
You likely can't join if
- Had major surgery within 4 weeks prior to randomization.
- Have active cytomegalovirus (CMV) disease.
See the full eligibility criteria
- Diagnosis of follicular lymphoma (FL).
- Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most recent representative tumor biopsy based on the local pathology report, according to the 5th edition of World Health Organization...
- Are willing and able to comply with procedures required in the protocol.
- Must have stage, III, IV or II with bulky disease \>= 7cm).
- Must be in need of systemic treatment per investigator, as evidenced by meeting at least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
- Has one or more target lesions:
- A positron emission tomography (PET)/computerized tomography (CT) scan demonstrating PET-positive lesion(s), and
- \>=1 measurable nodal lesion (long axis \>1.5cm) or \>=1 measurable extra-nodal lesion (long axis \>1.0 cm) on CT scan or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Able to receive at least one of the standard of care chemoimmunotherapy (CIT) treatment regimens: [Arm B] at the discretion of the Investigator, and rituximab and lenalidomide (R2) [Arm C].
- Have laboratory values meeting the criteria in the protocol.
- Had major surgery within 4 weeks prior to randomization.
- Have active cytomegalovirus (CMV) disease.
The study team makes the final eligibility decision.
Where it's taking place
- Fresno, California, United States
- San Diego, California, United States
- Santa Barbara, California, United States
- Boulder, Colorado, United States
- Newark, Delaware, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Coeur d'Alene, Idaho, United States
- Chicago, Illinois, United States
- Decatur, Illinois, United States
- Maywood, Illinois, United States
- Peoria, Illinois, United States
- Fort Wayne, Indiana, United States
- Des Moines, Iowa, United States
- Louisville, Kentucky, United States
- Westbrook, Maine, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
- Chesterfield, Missouri, United States
+ 213 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fresno, California, United States; San Diego, California, United States; Santa Barbara, California, United States; Boulder, Colorado, United States; Newark, Delaware, United States; Jacksonville, Florida, United States and 227 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.