At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Epcoritamab (drug), Prednisone (drug), Rituximab (drug), Lenalidomide (drug)
- How long the study runs
- Study runs about 165 months (dates as stated)
- About the drug or intervention
- Epcoritamab — drug: Subcutaneous (SC) Injection · Prednisone — drug: Oral Tablet · Rituximab — drug: Intravenous (IV) Infusion · Lenalidomide — drug: Oral Capsule · Doxorubicin — drug: IV Injection · Vincristine — drug: IV Injection · Cyclophosphamide — drug: IV Injection · Obinutuzumab — drug: IV Infusion · Bendamustine — drug: IV Infusion
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 1,095
- Started
- 2024-02-05
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for follicular lymphoma (fl)
- • Phase3 - 1,095 participants
- • Follicular lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with follicular lymphoma (fl)
Where?
- • Plymouth - University Hospitals Plymouth NHS Trust /ID# 262671
- • London - Hammersmith Hospital /ID# 261124
- • Portsmouth - Queen Alexandra Hospital /ID# 269708
- • Leeds - Leeds Teaching Hospitals NHS Trust /ID# 260466
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ in the protocol
- ✓ stage, III, IV or II with bulky disease \>= 7cm)
What the study is looking for
- ✓Diagnosis of follicular lymphoma (FL).
- ✓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...
- ✓Has one or more target lesions:
Who cannot take part
- ✗Had major surgery within 4 weeks prior to randomization.
- ✗Have active cytomegalovirus (CMV) disease.
See the full criteria
Where Is This Study? (6 UK sites)
University Hospitals Plymouth NHS Trust /ID# 262671
Plymouth PL6 8DH, United Kingdom
Hammersmith Hospital /ID# 261124
London W12 0HS, United Kingdom
Queen Alexandra Hospital /ID# 269708
Portsmouth PO6 3LY, United Kingdom
Leeds Teaching Hospitals NHS Trust /ID# 260466
Leeds LS9 7TF, United Kingdom
The Christie Hospital /ID# 260463
Manchester M20 4BX, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 260792
Newcastle upon Tyne NE3 3HD, United Kingdom