RandomizedPhase 2NCT07783594
Randomized Phase 2 Study Of Epcoritamab Vs Watch And Wait InPatients With Previously Untreated Low Tumor Burden FollicularLymphoma
A Phase 2 study testing Epcoritamab and Observation in people with Randomized and Phase 2, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Randomized, Phase 2, Epcoritamab
- What is being tested?
- Epcoritamab and Observation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2027to 31 Dec 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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
- Administration of any investigational agent within 28 days of first dose of study drug.
- Participants who have undergone major surgery within 28 days or minor surgery within 3 days of first dose of study drug.
- Participants taking chronic corticosteroids for other diseases, unless administered at a dose equivalent to < 10 mg/day prednisone. For corticosteroids, prednisolone >20 mg daily (or equivalent) qualifies as immunosuppressive and thus is excluded for this use. Note:
- corticosteroids at any dose are permitted for control of lymphoma-related symptoms, including during screening, and for prophylaxis or AE management during the trial.
- Life expectancy < 6 months
- Prior exposure to epcoritamab or other CD3X CD20 bispecific, independently from indication
- Participants who have an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Participants who have a history of (non-infectious) pneumonitis that require steroids or has current pneumonitis.
- Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson Cancer Center
Houston, Texas, 77030
Dai Chihara, MD, 713-563-5426, DChihara@mdanderson.org
Dai Chihara, MD
About this study
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.
Read the detailed description
PRIMARY OBJECTIVE
- To compare time to next treatment (TTNT), defined as the time from randomization to initiation of new lymphoma directed systemic therapy, between participants with previously untreated, low tumor burden follicular lymphoma treated with epcoritamab versus watchful waiting.
- Conditions
- Randomized, Phase 2, Epcoritamab, Watch & Wait, Untreated, Tumor Burden
- Being tested
- Epcoritamab, Observation
- Medical subject headings
- Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpcoritamabDrug
Given by Injection
ObservationOther
Participant will be closely monitored until the disease gets worse and requires treatment, as determined by your treating doctor or at your request.
| Study group | Role | What they receive |
|---|---|---|
| EPCORI Arm | Experimental | Not described Receives: Drug: Epcoritamab |
| OBS Arm | Experimental | Not described Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start12 Feb 2027 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RandomizedStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genmab
- Responsible party
- Sponsor
- Investigators
- Dai Chihara, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07783594
- Sponsor's protocol ID
- 2025-1839
- Other IDs
- NCI-2026-06280
- Status last verified
- Sep 2026
- First submitted
- 21 Aug 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase 2 Study Of Epcoritamab Vs Watch And Wait InPatients With Previously Untreated Low Tumor Burden FollicularLymphoma
- ClinicalTrials.gov ID
- NCT07783594
- Acronym / sponsor ID
- 2025-1839
- Conditions
- Randomized, Phase 2, Epcoritamab, Watch & Wait, Untreated, Tumor Burden
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Genmab
- Study start
- 12 Feb 2027 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE
- To compare time to next treatment (TTNT), defined as the time from randomization to initiation of new lymphoma directed systemic therapy, between participants with previously untreated, low tumor burden follicular lymphoma treated with epcoritamab versus watchful waiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPCORI Arm | Experimental | Drug: Epcoritamab |
| OBS Arm | Experimental | Other: Observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpcoritamabGiven by Injection | Drug | EPCORI Arm |
| ObservationParticipant will be closely monitored until the disease gets worse and requires treatment, as determined by your treating doctor or at your request. | Other | OBS Arm |
Primary outcome
Safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dai Chihara, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epcoritamab and Observation in people with Randomized and Phase 2, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dai Chihara, MD ((713) 563-5426, DChihara@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs). (time frame: Through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.