35 Participants Needed

Epcoritamab + Rituximab for Follicular Lymphoma

Recruiting at 3 trial locations
RM
CC
HA
Overseen ByHeather A Walker, MPH
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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 - Dana-Farber ...

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

Examples of contraceptive methods with a failure rate of <1% per year.
I have not had any drug treatments for follicular lymphoma, but I may have had radiation or steroids.
Willingness to remain abstinent or to use two effective contraceptive methods.
See 6 more

Exclusion Criteria

I have severe heart failure or my heart pumps less blood than normal.
I have not had major surgery or significant injury in the last 4 weeks.
I do not have any severe or uncontrolled medical conditions.
See 23 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

9-10 months
Multiple visits per cycle for drug administration and evaluations

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.

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.

10 years

Treatment Details

Interventions

  • Epcoritamab
  • Rituximab
Trial Overview The trial is testing a combination of two drugs: Rituximab (a monoclonal antibody) and Epcoritamab (a T-cell bispecific antibody), to see how safe and effective they are together as a first-line treatment for patients with Follicular Lymphoma who haven't been treated before.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Epcoritamab + RituximabExperimental Treatment2 Interventions
Participants will undergo study procedures as outlined: * PET/CT scans at baseline and after cycles 2, 5, and 9 of treatment. * Cycle 1: * Days -14, -7, 1, 8 of 6 week cycle: Predetermined dose of Rituximab. * Days 1, 8, 15, 22 of 6 week cycle: Predetermined dose of Epcoritamab. (Day 15 of Epcoritamab dosage will be administered in the hospital.) * Cycles 2 - 3: --Days 1, 8, 15, 22 of 4 week cycle: Predetermined dose of Epcoritamab. * Cycles 4 - 9: * Day 1 of 4 week cycle: Predetermined dose of Epcoritamab. * Day 15 of 4 week cycle: Predetermined dose of Epcoritamab. * Surveillance imaging (PT/CT scans) at months 13, 18, and 24 after initiation of treatment. * Follow up visits for up to 5 years.

Epcoritamab is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Epkinly for:
  • 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
🇪🇺
Approved in European Union as Tepkinly for:
  • 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

Trials
3
Recruited
110+

AbbVie

Industry Sponsor

Trials
1,079
Recruited
535,000+
Founded
2013
Headquarters
North Chicago, USA
Known For
Immunology treatments
Top Products
Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Genmab

Industry Sponsor

Trials
76
Recruited
15,300+

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

Findings from Research

Rituximab combined with chemotherapy significantly improves response rates and progression-free survival (PFS) in patients with advanced stage symptomatic follicular non-Hodgkin's lymphoma (NHL), without increasing toxicity, based on data from large-scale phase III trials.
Patients with follicular NHL should receive rituximab plus chemotherapy as first-line treatment, and maintenance therapy with rituximab has been shown to further prolong PFS in both relapsed and newly diagnosed patients.
Use of rituximab in patients with follicular lymphoma.Marcus, R.[2019]
The use of the anti-CD20 monoclonal antibody rituximab has significantly improved survival rates in patients with follicular lymphoma (FL), especially when used in combination with chemotherapy for both induction and maintenance therapy.
Radioimmunotherapy (RIT) using radiolabelled anti-CD20 mAbs, such as (90)Y Ibritumomab tiuxetan and (131)I Tositumomab, has shown high response rates and durable remissions, particularly when used as consolidation therapy after initial treatment.
How have outcomes for patients with follicular lymphoma changed with the addition of monoclonal antibodies?Illidge, T., Chan, C.[2019]
Rituximab is highly effective for treating low-grade CD20+ lymphoma, especially when combined with chemotherapy, which is the standard treatment for follicular lymphoma (FL).
The efficacy of rituximab can be enhanced by combining it with biological agents like interferon-alpha-2a, bortezomib, or lenalidomide, but more research is needed to determine the best combinations and timing of these treatments.
Biological therapy doublets: pairing rituximab with interferon, lenalidomide, and other biological agents in patients with follicular lymphoma.Kimby, E.[2021]

References

Use of rituximab in patients with follicular lymphoma. [2019]
How have outcomes for patients with follicular lymphoma changed with the addition of monoclonal antibodies? [2019]
Biological therapy doublets: pairing rituximab with interferon, lenalidomide, and other biological agents in patients with follicular lymphoma. [2021]
Phase II trial of short-course CHOP-R followed by 90Y-ibritumomab tiuxetan and extended rituximab in previously untreated follicular lymphoma. [2016]
[Therapy of follicular lymphoma]. [2018]
Critical appraisal of rituximab in the maintenance treatment of advanced follicular lymphoma. [2022]
Phase 2 multicentre study of single-agent ofatumumab in previously untreated follicular lymphoma: CALGB 50901 (Alliance). [2021]
Efficacy and safety of new anti-CD20 monoclonal antibodies versus rituximab for induction therapy of CD20+ B-cell non-Hodgkin lymphomas: a systematic review and meta-analysis. [2023]
The combination of ibrutinib and rituximab demonstrates activity in first-line follicular lymphoma. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Phase 2 study of a combined immunochemotherapy using rituximab and fludarabine in patients with chronic lymphocytic leukemia. [2022]
Update on front-line therapy for follicular lymphoma: chemo-immunotherapy with rituximab and survival. [2015]
12.United Statespubmed.ncbi.nlm.nih.gov
A phase 2 trial of extended induction epratuzumab and rituximab for previously untreated follicular lymphoma: CALGB 50701. [2021]
Treatment of follicular lymphoma--a review. [2016]