Lenalidomide and Epcoritamab for the Treatment of Previously Untreated Follicular Lymphoma

NCT06112847 | Active Not Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: 22509NCI-2023-08814P30CA033572
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Follicular Lymphoma

Outcome Measures

Primary Outcomes (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.

  Up to 2 years

Secondary Outcomes (4)

• Incidence of adverse events (AEs)

  Up to 2 years

• Overall response rate (ORR)

  Up to 2 years

• Progression free survival (PFS)

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

• Duration of response (DOR)

  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

Study Arms (1)

Treatment (lenalidomide and epcoritamab)

EXPERIMENTAL

Patients 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.

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

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (lenalidomide and epcoritamab)

Bone Marrow Biopsy PROCEDURE

Undergo bone marrow biopsy

Also known as: Biopsy of Bone Marrow, Biopsy, Bone Marrow

Treatment (lenalidomide and epcoritamab)

Computed Tomography PROCEDURE

Undergo CT or PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, CT, CT Scan, tomography

Treatment (lenalidomide and epcoritamab)

Epcoritamab BIOLOGICAL

Given SC

Also known as: Anti-CD20/CD3 Bispecific Antibody GEN3013, DuoBody-CD3xCD20, Epcoritamab-bysp, Epkinly, GEN 3013, GEN-3013, GEN3013

Treatment (lenalidomide and epcoritamab)

Electronic Health Record Review OTHER

Ancillary studies

Treatment (lenalidomide and epcoritamab)

Lenalidomide DRUG

Given PO

Also known as: CC-5013, CC5013, CDC 501, Revlimid

Treatment (lenalidomide and epcoritamab)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Treatment (lenalidomide and epcoritamab)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Treatment (lenalidomide and epcoritamab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Specimen Handling; Biopsy; Lenalidomide; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Cytodiagnosis; Cytological Techniques; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Swetha Kambhampati

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: January 24, 2024
• Primary Completion (Estimated): July 17, 2026
• Study Completion (Estimated): July 17, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (2)