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Follicular LymphomaPhase 2NCT06112847

Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma

A Phase 2 study testing Biospecimen Collection, Bone Marrow Biopsy and Computed Tomography in people with Follicular Lymphoma, run by City of Hope Medical Center at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial tests how well lenalidomide and epcoritamab works in treating patients with follicular lymphoma that has not been previously treated. Although follicular lymphoma is incurable, prognosis has improved for both early and advanced stage disease, largely attributed to therapeutic advances. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma
What is being tested?
Biospecimen Collection, Bone Marrow Biopsy and Computed Tomography
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
2 sitesUnited States
Study dates
24 Jan 2024to 10 Aug 2027
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

  • Documented informed consent of the participant and/or legally authorized representative
  • Assent, when appropriate, will be obtained per institutional guidelines
  • Age: ≥ 18 years
  • Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Histologically confirmed previously untreated FL grade 1-3a, requiring therapy per Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria
  • Radiologically measurable lymphadenopathy (> 1.5 cm) or extranodal involvement (including spleen, bone marrow or other extranodal site)
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  • Without bone marrow involvement: Absolute neutrophil count (ANC) ≥ 1,000/mm^3 With bone marrow involvement: ANC ≥ 500/mm^3
  • NOTE: Growth factor is not permitted within 14 days of ANC assessment unless cytopenia is secondary to disease involvement
  • Without bone marrow involvement: Platelets ≥ 50,000/mm^3 With bone marrow involvement: Platelets ≥ 25,000/mm^3
  • NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement.
  • Total bilirubin ≤ 2 x upper limit of normal (ULN) (unless has Gilbert's disease)
  • Aspartate aminotransferase (AST) ≤ 2.5 x ULN
  • Alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Creatinine clearance of ≥ 45 mL/min per 24 hour urine test or the Cockcroft-Gault formula or creatinine level < 1.5 mg/dL
  • If not receiving anticoagulants: International normalized ratio (INR) OR prothrombin (PT) ≤ 1.5 x ULN
  • If not receiving anticoagulants: Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
  • Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test
  • If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
  • Agreement by females and males of childbearing potential* to use an effective method of birth control (i.e., failure rate of < 1% per year) or abstain from heterosexual activity for the course of the study treatment period through at least 30 days after the last dose of lenalidomide, and 2 months after the last dose of epcoritamab, or 4 months after the last dose of tocilizumab (if applicable) whichever is longer
  • Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from .menses for > 1 year (women only)
  • All study participants must be registered into the mandatory Revlimid Risk Evaluation and Mitigation Strategy (REMS)® program and be willing and able to comply with the requirements of the REMS program (including use of aspirin [ASA]/Food and Drug Administration [FDA] approved blood thinner)
  • Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS program

Who cannot join

  • Prior therapeutic intervention with any anti-cancer agents; localized radiotherapy ≤ 20 Gy total dose is permissible if occurred ≥ 4 weeks prior to first dose of study medication.
  • Participants must have at least one non-irradiated target lesion
  • Concurrent enrollment in another therapeutic investigational study
  • Vaccinated with live vaccines within 4 weeks of the first dose of study drug
  • Current evidence of central nervous system involvement by the lymphoma
  • Grade 3b or transformed FL
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  • History of prior malignancy except:
  • Malignancy treated with curative intent and no known active disease present for ≥ 2 years prior to initiation of therapy on current study
  • Adequately treated non-melanoma skin cancer or lentigo maligna (melanoma in situ) without evidence of disease
  • Asymptomatic prostate cancer managed with "watch and wait" strategy or hormonal therapy
  • Uncontrolled active systemic infection
  • Absolute lymphocyte count > 5,000/uL
  • Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Patients with past HBV infection (defined as negative hepatitis B virus surface protein antigen [HbsAg] and positive hepatitis B core antibody [HbcAb]) are eligible if HBV deoxyribonucleic acid (DNA) is undetectable. Patients who are positive for HCV antibody are eligible if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). Testing to be done only in patients suspected of having infections or exposures
  • Known active human immunodeficiency virus (HIV) infection. Subjects who have an undetectable or unquantifiable HIV viral load with CD4 > 200 and are on highly active antiretroviral therapy (HAART) medication are allowed. Testing to be done only in patients suspected of having infections or exposures
  • Currently active, clinically significant cardiovascular disease, such as uncontrolled arrhythmia or class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification; or a history of myocardial infarction, unstable angina, or acute coronary syndrome within 6 months of screening
  • Females only: Pregnant or breastfeeding or intending to become pregnant during the study or within 6 months after the final dose of all study drugs
  • Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study drug
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • City of Hope Medical Center

    Duarte, California, 91010

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

Other trials in United States

About this study

Official title: A Phase 2 Study of Epcoritamab and Lenalidomide (E-Len) in Patients With Previously Untreated Follicular Lymphoma (FL)

This phase II trial tests how well lenalidomide and epcoritamab works in treating patients with follicular lymphoma that has not been previously treated. Although follicular lymphoma is incurable, prognosis has improved for both early and advanced stage disease, largely attributed to therapeutic advances. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Epcoritamab is a bispecific monoclonal antibody that binds to two different antigens (the part of the target that the antibody attaches to), at the same time. This dual action allows bispecific antibodies to improve target specificity by binding two antigens on the same cell to recruit and activate immune cells to kill cancer cells. Lenalidomide and epcoritamab, when given together, may be more effective in treating patients with follicular lymphoma than if they were given alone.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To assess efficacy (complete response [CR] rate) of epcoritamab and lenalidomide (E-Len) in patients with de novo follicular lymphoma (FL).

SECONDARY OBJECTIVES:

  1. To further assess efficacy of the combination (objective response rate [ORR], progression free survival [PFS], duration of response).

II. To characterize the adverse event profile of the combination.

EXPLORATORY OBJECTIVES:

  1. To characterize the T-cell population balance in patients treated with E-Len.

II. To evaluate the predictive role of genetic mutations on durability of response to E-Len (including m7 Follicular Lymphoma International Prognostic Index [FLIPI] score).

III. To evaluate minimal residual disease (MRD) dynamics on treatment.

OUTLINE:

Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21 of each cycle and epcoritamab subcutaneously (SC) on days 1, 8, 15, and 21 of cycles 1-3 and on day 1 of each subsequent cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients may be re-treated with study treatment at any point during the follow-up period as long as they did not progress during treatment or stop due to unacceptable toxicity. Patients also undergo computed tomography (CT), positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI) as well as bone marrow biopsy throughout the trial. Patients undergo blood sample collection on trial and during follow-up.

After completion of study treatment, patients are followed for safety on days 7, 30, and 60, for active response every 6 months for up to 2 years, and then for survival every 6 months.

Being tested
Biospecimen Collection, Bone Marrow Biopsy, Computed Tomography, Electronic Health Record Review, Epcoritamab
Medical subject headings
Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of Bone Marrow, Biopsy, Bone Marrow

    Undergo bone marrow biopsy

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT or PET/CT

  • Electronic Health Record ReviewOther

    Ancillary studies

  • EpcoritamabBiological

    Also called Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20, Epcoritamab-bysp, Epkinly

    Given SC

  • LenalidomideDrug

    Also called CC-5013, CC5013, CDC 501, Revlimid

    Given PO

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET/CT

Study groups in NCT06112847
Study groupRoleWhat they receive
Treatment (lenalidomide and epcoritamab)ExperimentalPatients receive lenalidomide PO QD on days 1-21 of each cycle and epcoritamab SC on days 1, 8, 15, and 21 of cycles 1-3 and on day 1 of each subsequent cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients may be re-treated with study treatment at any point during the follow-up period as long as they did not progress during treatment or stop due to unacceptable toxicity. Patients also undergo CT, PET/CT, or MRI as well as bone marrow biopsy throughout the trial. Patients undergo blood sample collection on trial and during follow-up.
Receives: Procedure: Biospecimen Collection; Procedure: Bone Marrow Biopsy; Procedure: Computed Tomography; Other: Electronic Health Record Review; Biological: Epcoritamab; Drug: Lenalidomide; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete response (CR) rate

    Defined as the proportion of response evaluable patients who achieve a complete response according to Lugano criteria on study before any documented disease progression or any subsequent non-Hodgkin lymphoma (NHL) treatment. Disease assessment will be performed by positron emission tomography (PET)-computed tomography (CT), CT, magnetic resonance imaging and/or bone marrow biopsy. PET-CT and CT results will be read by a radiologist and investigator response assessment will be performed. CR rate will be estimated along with the 95% exact binomial confidence interval.

    Measured: Up to 2 years

Secondary outcomes (4)

  1. Incidence of adverse events (AEs)

    Toxicity will be evaluated by Common Terminology Criteria for Adverse Events version 5 AE terms and grades. Observed toxicities will be summarized by type, severity, and attribution.

    Measured: Up to 2 years

  2. Overall response rate (ORR)

    The proportion of response evaluable patients who achieve CR or partial response (PR) according to Lugano 2016 guidelines on study before any documented disease progression or any subsequent NHL treatment. ORR will be estimated along with the 95% exact binomial confidence interval.

    Measured: Up to 2 years

  3. Progression free survival (PFS)

    PFS will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median PFS will be estimated when possible.

    Measured: From start of protocol treatment to disease relapse/progression or death due to any cause, whichever is earlier, assessed up to 2 years

  4. Duration of response (DOR)

    Response will be graded by the Lugano 2016 criteria. DOR will be estimated using the product-limit method of Kaplan and Meier along with the Greenwood estimator of standard error; 95% confidence interval will be constructed based on log-log transformation. Median DOR will be estimated when possible.

    Measured: From the first achievement of CR or PR to disease progression/relapse or death due to any cause, whichever is earlier, assessed up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2023
  2. Study start24 Jan 2024
  3. Primary completion10 Aug 2027 (estimated)
  4. Study completion10 Aug 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06112847
Sponsor's protocol ID
22509
Other IDs
NCI-2023-08814, 22509, P30CA033572
Status last verified
Aug 2026
First submitted
27 Oct 2023
Last updated
26 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Biospecimen Collection, Bone Marrow Biopsy and Computed Tomography in people with Follicular Lymphoma, run by City of Hope Medical Center at 2 sites 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 22 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete response (CR) rate (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06112847.

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 26 Aug 2026.

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