TriangleNCT05409066 · CITED IN SOURCE DOCUMENTS
Study of Subcutaneous Epcoritamab in Combination With Intravenous Rituximab and Oral Lenalidomide (R2) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Follicular Lymphoma
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-07-08
Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m\^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
No posted result sections were captured. Registered plans do not establish that a treatment works.
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status score 0 to 2. * Participant has: * Fluorodeoxyglucose-positron emission tomography (FDG-PET) scan demonstrating positive lesion compatible with computed tomography (CT) or magnetic resonance image (MRI)-defined anatomical tumor sites AND * \>= 1 measurable nodal lesion (long axis \> 1.5 cm) or \>= 1 measurable extra-nodal lesion (long axis \> 1.0 cm) on CT scan or MRI. * Histologically confirmed classic follicular lymphoma (FL) \[previously Grade 1 to 3a FL\] stage II, III, or IV with no evidence of histologic transformation to an aggressive lymphoma and CD20+ disease on most recent representative tumor biopsy based on the pathology report. * Relapsed or refractory (R/R) disease to at least one prior systemic regimen that contained an anti-CD20 monoclonal antibody (mAb) in combination with chemotherapy. (Participant who received only prior anti-CD20 mAb monotherapy and/or radiation therapy is not eligible.) * Eligible to receive R2 per investigator determination. * Estimated Creatinine Clearance (CrCl) \>= 50 mL/min. Exclusion Criteria: * Documented refractoriness to lenalidomide. * Have lenalidomide exposure within 12 months prior to randomization.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Participants will receive epcoritamab Dose A in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
- intervention Names
- Drug: Epcoritamab
- Drug: Rituximab
- Drug: Lenalidomide
- label
- Epcoritamab Dose A in Combination With R2
- type
- EXPERIMENTAL
- description
- Participants will receive epcoritamab Dose B in combination with lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days). Enrollment is closed for this arm.
- intervention Names
- Drug: Epcoritamab
- Drug: Rituximab
- Drug: Lenalidomide
- label
- Epcoritamab Dose B in Combination With R2
- type
- EXPERIMENTAL
- description
- Participants will receive lenalidomide and rituximab (R2) for 12 cycles (each cycle is 28 days).
- intervention Names
- Drug: Rituximab
- Drug: Lenalidomide
- label
- Lenalidomide and Rituximab (R2)
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Epcoritamab Dose A in Combination With R2
- Epcoritamab Dose B in Combination With R2
- description
- Subcutaneous Injection
- name
- Epcoritamab
- type
- DRUG
- arm Group Labels
- Epcoritamab Dose A in Combination With R2
- Epcoritamab Dose B in Combination With R2
- Lenalidomide and Rituximab (R2)
- description
- Intravenous Infusion
- name
- Rituximab
- type
- DRUG
- arm Group Labels
- Epcoritamab Dose A in Combination With R2
- Epcoritamab Dose B in Combination With R2
- Lenalidomide and Rituximab (R2)
- description
- Oral Capsules
- name
- Lenalidomide
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 549
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- BOR is defined as Complete Response (CR) or Partial Response (PR), determined by Lugano criteria, as assessed by an IRC.
- measure
- Percentage of Participants Achieving Best Overall Response (BOR)
- time Frame
- Up to approximately 2 years and 3 months
- description
- PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by independent review committee (IRC) or death (whichever occurs first).
- measure
- Progression-Free Survival (PFS)
- time Frame
- Up to approximately 2 years and 3 months
- secondary Outcomes
- description
- Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.
- measure
- Percentage of Participants Achieving CR
- time Frame
- Up to approximately 5 years
- description
- Overall survival is defined as the duration from the date of randomization to the date of the participant's death.
- measure
- Overall Survival (OS)
- time Frame
- Up to approximately 8 years from randomization
- description
- MRD negativity rate is defined as the percentage of participants who achieve MRD negative status prior to the initiation of subsequent anti-lymphoma therapy.
- measure
- Percentage of Participants Achieving Minimal Residual Disease (MRD) Negativity
- time Frame
- Up to approximately 5 years
- description
- The objective of the FACT-Lym patient-reported outcome (PRO) is to address health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Like-type scale, with a higher score signifying a higher quality of life.
- measure
- Change in Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
- time Frame
- Up to approximately 8 years
- description
- PFS is defined as duration from the date of randomization to the date of disease progression determined by Lugano criteria by investigator or death (whichever occurs first).
- measure
- PFS as Assessed by Investigator
- time Frame
- Up to approximately 5 years
- description
- BOR is defined as CR PR, determined by Lugano criteria, as assessed by an investigator.
- measure
- Percentage of Participants Achieving BOR as Assessed by Investigator
- time Frame
- Up to approximately 5 years
- description
- Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the investigator prior to the initiation of subsequent anti-lymphoma therapy.
- measure
- Percentage of Participants Achieving CR as Assessed by Investigator
- time Frame
- Up to approximately 5 years
- description
- DOR is defined as the time from the first occurrence of response (CR or PR) to disease progression or death, whichever occurs first.
- measure
- Duration of Response (DOR)
- time Frame
- Up to approximately 8 years
- description
- DOR is defined as the time from the first occurrence of CR to disease progression or death, whichever occurs first.
- measure
- Duration of Complete Response (DOCR)
- time Frame
- Up to approximately 8 years
- description
- Time to progression is defined as the number of days from the date of study drug start to the date of the first documented disease progression or relapse.
- measure
- Time to Progression (TTP)
- time Frame
- Up to approximately 8 years
- description
- Time to next anti-lymphoma treatment is defined as the number of days from the date of the first documented disease progression or relapse to the date of next anti-lymphoma treatment.
- measure
- Time to Next Anti-Lymphoma Treatment (TTNLT)
- time Frame
- Up to approximately 8 years
- description
- Percentage of participants who achieve a CR determined per Lugano criteria, as assessed by the IRC prior to the initiation of subsequent anti-lymphoma therapy.
- measure
- Percentage of Participants Achieving CR at the End of Treatment
- time Frame
- Up to approximately 5 years
Full study description
- brief Summary
- Follicular Lymphoma (FL) is the second most common B-cell cancer and the most common type of cancer of lymphocytes. Unfortunately, this disease is incurable with conventional treatment and the disease recurs in almost all patients. This study will assess how safe and effective epcoritamab is in combination with lenalidomide and rituximab (R2) in treating adult participants with relapsed or refractory (R/R) FL. Adverse events and change in disease condition will be assessed. Epcoritamab is an investigational drug being developed for the treatment of FL. Study doctors put the participants in 1 of 3 groups, called treatment arms. Each group receives a different treatment. Enrollment to one of the groups is closed. Around 500 adult participants with R/R FL will be enrolled in approximately 300 sites across the world. Participants will receive R2 (375 mg/m\^2 intravenous infusion of rituximab up to 5 cycles and oral capsules of 20 mg lenalidomide for up to 12 cycles) alone or in combination with subcutaneous injections of epcoritamab for up to 12 cycles (each cycle is 28 days). There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Source references
- references
- citation
- Falchi L, Nijland M, Huang H, Linton KM, Seymour JF, Tao R, Kwiatek M, Costa A, Vassilakopoulos TP, Greil R, Jimenez-Ubieto A, Gangatharan SA, Benjamini O, Thieblemont C, Tucci A, Elinder-Camburn A, Illes A, Novak J, Pavlovsky MA, McDonald A, Yoon DH, Maruyama D, Sunkersett G, Mei JP, Mukherjee N, Zhu F, Alshreef A, Favaro E, Morschhauser F; EPCORE FL-1 Investigators. Epcoritamab, lenalidomide, and rituximab versus lenalidomide and rituximab for relapsed or refractory follicular lymphoma (EPCORE FL-1): a global, open-label, randomised, phase 3 trial. Lancet. 2026 Jan 10;407(10524):161-173. doi: 10.1016/S0140-6736(25)02360-8. Epub 2025 Dec 7.
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- type
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Preserved source evidence · Not medical advice