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T-cell bispecific antibody
Epcoritamab + Rituximab for Follicular Lymphoma
Phase 2
Recruiting
Research Sponsored by Reid Merryman, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will assess the efficacy and safety of rituximab-epcoritamab combination therapy in FL patients who have not received prior therapy.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include allergic reactions to the antibodies used in treatment. Since these drugs affect the immune system's response to cancer cells, there could be inflammation-related symptoms or changes in blood counts that might increase infection risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
End of Treatment (EOT) Complete Metabolic Response (CMR) Rate
Secondary study objectives
2-year Duration of Complete Response (DOCR)
2-year Duration of Response (DOR)
2-year Overall Survival (OS)
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rituximab
1999
Completed Phase 4
~2990
Find a Location
Who is running the clinical trial?
AbbVieIndustry Sponsor
1,022 Previous Clinical Trials
520,144 Total Patients Enrolled
Reid Merryman, MDLead Sponsor
2 Previous Clinical Trials
74 Total Patients Enrolled
GenmabIndustry Sponsor
70 Previous Clinical Trials
14,672 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.I am eligible for radiation therapy aimed at curing my condition.I have had a solid organ or bone marrow transplant.I have been cancer-free from another type for at least 2 years.I have not received any live vaccines in the last 28 days.I haven't taken any experimental drugs within the last 4 weeks or 5 half-lives before starting epcoritamab.I have large neck lymph nodes that are affecting my breathing.I have not had any drug treatments for follicular lymphoma, but I may have had radiation or steroids.I haven't had any live vaccines in the week before or during the study.My blood counts and organ functions are within normal ranges.I am willing to provide a tumor sample through a biopsy.I have not had CAR-T therapy in the last 100 days.My condition is stage I follicular lymphoma.I have a history of HLH.I do not have any current infections or significant infections in the last 2 weeks.I have no severe allergies to anti-CD20 therapy or epcoritamab components.I have active lymphoma in my brain or spinal cord.I am 18 years old or older.I have a history of serious heart or stroke issues.I haven't had chemotherapy or cancer drugs for at least 4 weeks or 5 half-lives before starting epcoritamab.My cancer is a type of non-Hodgkin lymphoma called follicular lymphoma.I am able to get out of my bed or chair and move around.I do not have severe nerve pain or damage.I need medication to suppress my immune system for another health issue.
Research Study Groups:
This trial has the following groups:- Group 1: Epcoritamab + Rituximab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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