Epcoritamab + Rituximab for Follicular Lymphoma
Trial Summary
What is the purpose of this trial?
The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma. The names of the study drugs involved in this study are: * Rituximab (a type of monoclonal antibody therapy) * Epcoritamab (a T-cell bispecific antibody)
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressive therapy or taking more than 10 mg of prednisone daily, you may not be eligible to participate.
What data supports the effectiveness of the drug combination Epcoritamab and Rituximab for treating follicular lymphoma?
Rituximab, a key component of the treatment, has been shown to improve survival rates and increase the time patients live without their disease getting worse when combined with chemotherapy for follicular lymphoma. This suggests that combining Rituximab with other drugs, like Epcoritamab, could potentially enhance treatment effectiveness.12345
Is the combination of Epcoritamab and Rituximab safe for treating follicular lymphoma?
Rituximab has been used for many years in treating follicular lymphoma and is generally considered safe, though it can cause mild side effects like fever and chills, especially during the first infusion. Serious side effects are rare, but new safety alerts can arise, so it's important for doctors to monitor patients closely.678910
What makes the drug combination of Epcoritamab and Rituximab unique for treating follicular lymphoma?
The combination of Epcoritamab and Rituximab is unique because it pairs a novel bispecific antibody (Epcoritamab) that targets both CD3 and CD20 proteins on immune cells, with Rituximab, a well-established anti-CD20 antibody. This dual-targeting approach may enhance the immune system's ability to attack lymphoma cells more effectively than traditional treatments.35111213
Research Team
Reid W Merryman, MD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
Adults with untreated Follicular Lymphoma (FL) who are not in urgent need of chemotherapy can join this trial. They must have good organ function, no prior systemic therapy for FL except radiation or short steroids, and agree to use effective contraception. Exclusions include recent major surgery, active infections like hepatitis B/C or HIV, severe medical conditions affecting study participation, certain heart issues within the last 6 months, pregnancy, breastfeeding intentions during the study period.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Rituximab and Epcoritamab. Cycle 1 includes Rituximab on Days -14, -7, 1, 8 and Epcoritamab on Days 1, 8, 15, 22 of a 6-week cycle. Cycles 2-3 include Epcoritamab on Days 1, 8, 15, 22 of a 4-week cycle. Cycles 4-9 include Epcoritamab on Days 1 and 15 of a 4-week cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with surveillance imaging at months 13, 18, and 24, and follow-up visits for up to 5 years.
Long-term follow-up
Participants are monitored for long-term outcomes, including overall survival and incidence of histological transformation, for up to 10 years.
Treatment Details
Interventions
- Epcoritamab
- Rituximab
Epcoritamab is already approved in United States, European Union for the following indications:
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
- Diffuse large B-cell lymphoma after two or more lines of systemic therapy
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
- Relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Reid Merryman, MD
Lead Sponsor
AbbVie
Industry Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Genmab
Industry Sponsor
Dr. Jan van de Winkel
Genmab
Chief Executive Officer since 2010
PhD in Immunology, University of Utrecht
Dr. Judith Klimovsky
Genmab
Chief Medical Officer since 2019
MD, University of Copenhagen