Randomized Phase 2 Study Of Epcoritamab Vs Watch And Wait InPatients With Previously Untreated Low Tumor Burden FollicularLymphoma
2 other identifiers
interventional
40
1 country
1
Brief Summary
To compare the time to next treatment between patients with previously untreated, low tumor burden FL who receive the study drug epcoritamab versus those who do not receive epcoritamab and are monitored only.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2027
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2026
CompletedFirst Posted
Study publicly available on registry
August 25, 2026
CompletedStudy Start
First participant enrolled
February 12, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
Study Completion
Last participant's last visit for all outcomes
December 31, 2030
August 25, 2026
August 1, 2026
1.9 years
August 21, 2026
August 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Through study completion; an average of 1 year
Study Arms (2)
EPCORI Arm
EXPERIMENTALOBS Arm
EXPERIMENTALInterventions
Participant will be closely monitored until the disease gets worse and requires treatment, as determined by your treating doctor or at your request.
Eligibility Criteria
You may not qualify if:
- Known active central nervous system lymphoma or leptomeningeal disease
- Any prior history of other malignancy besides B-NHL, unless the participant has been free of disease for ≥ 3 years and felt to be at low risk for recurrence by the treating physician, except:
- Adequately treated localized skin cancer without evidence of disease.
- Adequately treated breast cancer without evidence of disease.
- Adequately treated prostate cancer or monitored with watch and wait for low risk disease without evidence of progressive disease.
- Adequately treated cervical carcinoma in situ without evidence of disease.
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
- Uncontrolled human immunodeficiency virus (HIV), or active Hepatitis C Virus, or active Hepatitis B Virus infection, or any uncontrolled active significant infection, including suspected or confirmed JC virus infection and SARS-CoV2
- Participants with inactive hepatitis B infection must adhere to hepatitis B reactivation prophylaxis unless contraindicated. Hepatitis B or C serologic status: subjects who are hepatitis B core antibody (anti-HBc) positive and who are surface antigen negative will need to have a negative polymerase chain reaction (PCR). Those who are hepatitis B surface antigen (HbsAg) positive or hepatitis B PCR positive will be excluded. Subjects who are hepatitis C antibody positive will need to have a negative PCR result. Those who are hepatitis C PCR positive will be excluded. Subjects with a history of Hepatitis C who received antiviral treatment are eligible as long as PCR is negative.
- History of immunodeficiency (with the exception of hypogammaglobulinemia) or concurrent systemic immunosuppressant therapy (e.g., cyclosporine, tacrolimus, etc., or chronic administration glucocorticoid equivalent of \>10mg/day of prednisone) within 28 days of the first dose of study drug
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification. Subjects with controlled, asymptomatic atrial fibrillation during screening can enroll on study
- Significant screening electrocardiogram (ECG) abnormalities including, 2nd degree atrioventricular (AV) block, type II AV block, or 3rd degree block.
- History of stroke, seizure disorder or participants requiring antiepileptic therapy or intracranial hemorrhage within 6 months prior to study entry.
- Participants with more than mild pericardial effusion confirmed by ECHO.
- Lactating or pregnant women
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- Genmabcollaborator
Study Sites (1)
UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dai Chihara, MD
UT MD Anderson Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2026
First Posted
August 25, 2026
Study Start (Estimated)
February 12, 2027
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2030
Last Updated
August 25, 2026
Record last verified: 2026-08