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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT06191744
Registration number
NCT06191744
Ethics application status
Date submitted
20/12/2023
Date registered
5/01/2024
Date last updated
10/06/2024
Titles & IDs
Public title
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 Previously Untreated Follicular Lymphoma
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Scientific title
A Phase 3, Multicenter, Randomized, Open-Label Trial to Evaluate the Safety and Efficacy of Epcoritamab + Rituximab and Lenalidomide (R2) Compared to Chemoimmunotherapy in Previously Untreated Follicular Lymphoma (EPCORE™FL-2)
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Secondary ID [1]
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2023-506906-38-00
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Secondary ID [2]
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M22-003
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Universal Trial Number (UTN)
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Trial acronym
EPCORE™FL-2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma (FL)
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Epcoritamab
Treatment: Drugs - Prednisone
Treatment: Drugs - Rituximab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Obinutuzumab
Treatment: Drugs - Bendamustine
Experimental: Arm A: Epcoritamab + Lenalidomide and Rituximab (R2) - Participants will receive epcoritamab in combination with R2 during the 120 week treatment duration.
Experimental: Arm B: Chemoimmunotherapy (CIT) Option A - Participants will receive CIT Option A (obinutuzumab (G) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) [G-CHOP]/ rituximab (R)-CHOP during the 120 week treatment duration.
Experimental: Arm B: Chemoimmunotherapy (CIT) Option B - Participants will receive CIT Option B (G and bendamustine (Benda) [G-Benda]/R-Benda during the 120 week treatment duration.
Experimental: Arm C: Lenalidomide and Rituximab (R2) - Participants will receive lenalidomide and rituximab (R2) during the 120 week treatment duration.
Treatment: Drugs: Epcoritamab
Subcutaneous (SC) Injection
Treatment: Drugs: Prednisone
Oral Tablet
Treatment: Drugs: Rituximab
Intravenous (IV) Infusion
Treatment: Drugs: Lenalidomide
Oral Capsule
Treatment: Drugs: Doxorubicin
IV Injection
Treatment: Drugs: Vincristine
IV Injection
Treatment: Drugs: Cyclophosphamide
IV Injection
Treatment: Drugs: Obinutuzumab
IV Infusion
Treatment: Drugs: Bendamustine
IV Infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Arm A vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)
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Assessment method [1]
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CR30 will be determined by positron emission tomography-computerized tomography (cat scan) [PET-CT] per Lugano 2014 criteria, as assessed by independent review committee (IRC).
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Timepoint [1]
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Up to 30 Months
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Primary outcome [2]
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Arm A vs Arm B: Number of Participants with Progression-free survival (PFS)
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Assessment method [2]
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PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
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Timepoint [2]
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Up to 10 Years
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Secondary outcome [1]
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Arm A vs Arm B: Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from the date of randomization to the date of death of any cause.
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Timepoint [1]
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Up to 10 Years
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Secondary outcome [2]
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Arm A vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate
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Assessment method [2]
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MRD negativity rate, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with follicular lymphoma (FL) MRD at baseline.
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Timepoint [2]
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Up to 10 Years
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Secondary outcome [3]
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Arm A vs Arm B: Percentage of Participants who Maintain Physical Functioning (PF) According to European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer (EORTC QLQ-C30)
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Assessment method [3]
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The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.
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Timepoint [3]
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25 Weeks
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Secondary outcome [4]
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Arm A vs Arm C: Percentage of Participants who Achieve CR30
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Assessment method [4]
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CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
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Timepoint [4]
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Up to 30 Months
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Secondary outcome [5]
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Arm A vs Arm C: Number of Participants with PFS
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Assessment method [5]
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PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
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Timepoint [5]
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Up to 10 Years
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Secondary outcome [6]
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Arm A vs Arm C: OS
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Assessment method [6]
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OS is defined as the time from the date of randomization to the date of death of any cause.
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Timepoint [6]
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Up to 10 Years
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Secondary outcome [7]
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Arm A vs Arm C: Rate of MRD Negativity
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Assessment method [7]
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MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.
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Timepoint [7]
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Up to 10 Years
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Secondary outcome [8]
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Arm A vs Arm C: Percentage of Participants who Maintain PF According to EORTC QLQ-C30
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Assessment method [8]
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The PF of EORTC QLQ-C30 is a 5-item questionnaire to assess the physical function of the participant, with a higher score indication worse functioning.
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Timepoint [8]
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Up to 10 Years
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Secondary outcome [9]
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Arm A vs Arm B: Percentage of Participants who Achieve CR30
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Assessment method [9]
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CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
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Timepoint [9]
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Up to 30 Months
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Secondary outcome [10]
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Arm A vs Arm C: Percentage of Participants who Achieve CR30
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Assessment method [10]
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CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
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Timepoint [10]
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Up to 30 Months
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Secondary outcome [11]
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Arm A vs Arm C: Number of Participants with PFS
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Assessment method [11]
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PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.
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Timepoint [11]
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Up to 10 Years
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Secondary outcome [12]
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Arm A vs Arm B: Percentage of Participants with Change in CR Rate per IRC
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Assessment method [12]
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CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
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Timepoint [12]
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Up to 10 Years
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Secondary outcome [13]
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Arm A vs Arm C: Percentage of Participants with Change in CR Rate per IRC
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Assessment method [13]
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CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
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Timepoint [13]
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Up to 10 Years
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Secondary outcome [14]
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Arm A vs Arm B: Percentage of Participants with Change in CR Rate per Investigator
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Assessment method [14]
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CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
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Timepoint [14]
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Up to 10 Years
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Secondary outcome [15]
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Arm A vs Arm C: Percentage of Participants with Change in CR Rate per Investigator
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Assessment method [15]
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CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
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Timepoint [15]
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Up to 10 Years
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Secondary outcome [16]
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Arm A vs Arm B: Number of Participants with Best Overall Response (BOR) per per Investigator
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Assessment method [16]
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BOR is defined as the percentage of participants who achieve CR or partial response (PR) determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
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Timepoint [16]
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Up to 10 Years
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Secondary outcome [17]
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Arm A vs Arm C: Number of Participants with BOR per Investigator
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Assessment method [17]
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BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
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Timepoint [17]
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Up to 10 Years
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Secondary outcome [18]
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Arm A vs Arm B: Number of Participants with BOR per IRC
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Assessment method [18]
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BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
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Timepoint [18]
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Up to 10 Years
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Secondary outcome [19]
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Arm A vs Arm C: Number of Participants with BOR per IRC
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Assessment method [19]
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BOR is defined as the percentage of participants who achieve CR or PR determined by Lugano 2014 criteria as assessed by IRC, or death from any cause.
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Timepoint [19]
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Up to 10 Years
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Secondary outcome [20]
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Arm A vs Arm B: Number of Participants with Event-free Survival (EFS) per IRC
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Assessment method [20]
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EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
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Timepoint [20]
0
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Up to 10 Years
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Secondary outcome [21]
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Arm A vs Arm C: Number of Participants with EFS per IRC
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Assessment method [21]
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EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
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Timepoint [21]
0
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Up to 10 Years
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Secondary outcome [22]
0
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Arm A vs Arm B: Number of Participants with EFS per Investigator
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Assessment method [22]
0
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EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.
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Timepoint [22]
0
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Up to 10 Years
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Secondary outcome [23]
0
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Arm A vs Arm C: Number of Participants with EFS per Investigator
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Assessment method [23]
0
0
EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.
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Timepoint [23]
0
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Up to 10 Years
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Secondary outcome [24]
0
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Arm A vs Arm B: Duration of Response (DOR) per IRC
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Assessment method [24]
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DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
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Timepoint [24]
0
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Up to 10 Years
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Secondary outcome [25]
0
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Arm A vs Arm C: DOR per IRC
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Assessment method [25]
0
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DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
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Timepoint [25]
0
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Up to 10 Years
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Secondary outcome [26]
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Arm A vs Arm B: DOR per Investigator
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Assessment method [26]
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DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
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Timepoint [26]
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Up to 10 Years
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Secondary outcome [27]
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Arm A vs Arm C: DOR per Investigator
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Assessment method [27]
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DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
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Timepoint [27]
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Up to 10 Years
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Secondary outcome [28]
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Arm A vs Arm B: Duration of Complete Response (DOCR) per IRC
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Assessment method [28]
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DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
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Timepoint [28]
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Up to 10 Years
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Secondary outcome [29]
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Arm A vs Arm C: DOCR per IRC
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Assessment method [29]
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DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
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Timepoint [29]
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Up to 10 Years
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Secondary outcome [30]
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Arm A vs Arm B: DOCR per Investigator
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Assessment method [30]
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DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
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Timepoint [30]
0
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Up to 10 Years
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Secondary outcome [31]
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Arm A vs Arm C: DOCR per Investigator
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Assessment method [31]
0
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DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
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Timepoint [31]
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Up to 10 Years
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Secondary outcome [32]
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Arm A vs Arm B: Time to Next Anti-lymphoma Therapy (TTNT)
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Assessment method [32]
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TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy
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Timepoint [32]
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Up to 10 Years
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Secondary outcome [33]
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Arm A vs Arm C: TTNT
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Assessment method [33]
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TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy
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Timepoint [33]
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Up to 10 Years
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Secondary outcome [34]
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Arm A vs Arm B: Time to Progression per IRC
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Assessment method [34]
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Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.
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Timepoint [34]
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Up to 10 Years
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Secondary outcome [35]
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Arm A vs Arm C: Time to Progression per IRC
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Assessment method [35]
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Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.
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Timepoint [35]
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Up to 10 Years
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Secondary outcome [36]
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Arm A vs Arm B: Time to Progression per Investigator
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Assessment method [36]
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Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.
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Timepoint [36]
0
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Up to 10 Years
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Secondary outcome [37]
0
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Arm A vs Arm C: Time to Progression per Investigator
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Assessment method [37]
0
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Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.
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Timepoint [37]
0
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Up to 10 Years
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Secondary outcome [38]
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Arm A vs Arm B: Number of Participants with Progression-free Survival After Subsequent Anti-Lymphoma Therapy (PFS2)
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Assessment method [38]
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PFS2 is defined as the time after subsequent anti-lymphoma therapy to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
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Timepoint [38]
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Up to 10 Years
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Secondary outcome [39]
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Arm A vs Arm C: Number of Participants with PFS2
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Assessment method [39]
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PFS2 is defined as the time after subsequent anti-lymphoma therapy to the earliest occurrence of disease progression determined by Lugano 2014 criteria as assessed by investigator, or death from any cause.
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Timepoint [39]
0
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Up to 10 Years
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Secondary outcome [40]
0
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Arm A vs Arm B: Change in Tolerability as Measured by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
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Assessment method [40]
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The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.
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Timepoint [40]
0
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Up to 10 Years
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Secondary outcome [41]
0
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Arm A vs Arm C: Change in Tolerability as Measured by PRO-CTCAE
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Assessment method [41]
0
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The PRO-CTCAE is a patient-reported outcome measurement system developed to assess symptomatic toxicity in participants in cancer clinical trials. PRO-CTCAE items evaluate common symptoms from study treatment on their frequency, severity, interference, amount, presence/absence.
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Timepoint [41]
0
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Up to 10 Years
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Secondary outcome [42]
0
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Arm A vs Arm B: Change in Tolerability as Measured by The Functional Assessment of Cancer Therapy Singly Item - GP5 (FACT-GP5)
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Assessment method [42]
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The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.
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Timepoint [42]
0
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Up to 10 Years
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Secondary outcome [43]
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Arm A vs Arm C: Change in Tolerability as Measured by FACT-GP5
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Assessment method [43]
0
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The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.
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Timepoint [43]
0
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Up to 10 Years
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Secondary outcome [44]
0
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Arm A vs Arm B: Change in Symptoms as Measured by The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
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Assessment method [44]
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The objective of the FACT-Lym patient reported outcome (PRO) is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.
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Timepoint [44]
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Up to 10 Years
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Secondary outcome [45]
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Arm A vs Arm C: Change in Symptoms as Measured by FACT-Lym
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Assessment method [45]
0
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The objective of the FACT-Lym patient reported outcome (PRO) is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.
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Timepoint [45]
0
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Up to 10 Years
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Secondary outcome [46]
0
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Arm A vs Arm B: Change in Quality of Life (QoL) as Measured by FACT-Lym
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Assessment method [46]
0
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The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.
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Timepoint [46]
0
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Up to 10 Years
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Secondary outcome [47]
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Arm A vs Arm C: Change in QoL as Measured by FACT-Lym
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Assessment method [47]
0
0
The objective of the FACT-Lym PRO is to assess health-related quality of life issues for adult lymphoma patients. It utilizes a 5-point Likert-type scale.
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Timepoint [47]
0
0
Up to 10 Years
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Secondary outcome [48]
0
0
Arm A vs Arm B: Change in QoL as Measured by 5-Level European Quality of Life (EuroQol)-5-dimension [EQ-5D-5L]
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Assessment method [48]
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The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.
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Timepoint [48]
0
0
Up to 10 Years
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Secondary outcome [49]
0
0
Arm A vs Arm C: Change in QoL as Measured by EQ-5D-5L
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Assessment method [49]
0
0
The EQ-5D-5L is a standardized, non-disease specific instrument used to measure health-related quality of life. The EQ-5D-5L assesses general health on 5 dimensions (mobility, self-care, usual activities, pain/discomfort and anxiety/depression). Each dimension has 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems). The scores for the 5 dimensions are used to compute a single utility index score ranging from 0 to 1 representing the general health status of the individual, with higher scores indicating better health state.
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Timepoint [49]
0
0
Up to 10 Years
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Secondary outcome [50]
0
0
Arm A vs Arm B: Change in Participant Belief in in Efficacy of Treatment as Measured by Patient Global Impression of Change (PGIC)
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Assessment method [50]
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The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
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Timepoint [50]
0
0
Up to 10 Years
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Secondary outcome [51]
0
0
Arm A vs Arm C: Change in Participant Belief in in Efficacy of Treatment as Measured by PGIC
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Assessment method [51]
0
0
The self-report measure PGIC reflects a participant's belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement since start of treatment. Participants rate their change as very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse.
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Timepoint [51]
0
0
Up to 10 Years
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Secondary outcome [52]
0
0
Arm A vs Arm B: Change in Participant Belief in in Efficacy of Treatment as Measured by Patient Global Impression of Severity (PGIS)
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Assessment method [52]
0
0
The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.
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Timepoint [52]
0
0
Up to 10 Years
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Secondary outcome [53]
0
0
Arm A vs Arm C: Change in Participant Belief in in Efficacy of Treatment as Measured by PGIS
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Assessment method [53]
0
0
The self-report measure PGIS reflects a participant's belief about their lymphoma symptoms over the past 7 days. The PGIS is a 5-point scale depicting a participant's rating of overall severity.
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Timepoint [53]
0
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Up to 10 Years
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Eligibility
Key inclusion criteria
- Diagnosis of follicular lymphoma (FL).
- Have CD20+, histologically confirmed classic FL (previously Grade 1 to 3a FL) at most
recent representative tumor biopsy based on the local pathology report, according to
the 5th edition of World Health Organization (WHO) Classification of Haematolymphoid
Tumours.
- Are willing and able to comply with procedures required in the protocol.
- Must have stage, II, III or IV disease.
- Must be in need of systemic treatment per investigator, as evidenced by meeting at
least one of the Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
- Has one or more target lesions:
- A positron emission tomography (PET)/computerized tomography (CT) scan
demonstrating PET-positive lesion(s), and
- >=1 measurable nodal lesion (long axis >1.5cm) or >=1 measurable extra-nodal
lesion (long axis >1.0 cm) on CT scan or MRI
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
- Able to receive at least one of the standard of care chemoimmunotherapy (CIT)
treatment regimens: [Arm B] at the discretion of the Investigator, and rituximab and
lenalidomide (R2) [Arm C].
- Have laboratory values meeting the criteria in the protocol.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Had major surgery within 4 weeks prior to randomization.
- Have active cytomegalovirus (CMV) disease.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/02/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
18/05/2037
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Actual
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Sample size
Target
1080
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Peter MacCallum Cancer Center /ID# 260431 - Melbourne
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Recruitment hospital [2]
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Westmead Hospital /ID# 261465 - Westmead
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Recruitment hospital [3]
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Townsville University Hospital /ID# 259323 - Douglas
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Recruitment hospital [4]
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Royal Perth Hospital /ID# 259319 - Perth
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Recruitment postcode(s) [1]
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3000 - Melbourne
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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4814 - Douglas
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Recruitment postcode(s) [4]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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Florida
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United States of America
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Illinois
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United States of America
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Indiana
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United States of America
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Iowa
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Missouri
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United States of America
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Montana
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United States of America
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New York
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United States of America
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Ohio
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United States of America
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South Carolina
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United States of America
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Washington
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Israel
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H_efa
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Israel
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HaDarom
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Israel
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State/province [15]
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HaMerkaz
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Israel
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State/province [16]
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Tel-Aviv
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Israel
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Yerushalayim
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Korea, Republic of
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Gyeonggido
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Korea, Republic of
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State/province [19]
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Seoul Teugbyeolsi
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Korea, Republic of
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Seoul
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Puerto Rico
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Rio Piedras
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Romania
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Bucuresti
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Romania
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State/province [23]
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Bucharest
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Country [24]
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Serbia
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State/province [24]
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Belgrade
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Country [25]
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Serbia
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Novi Sad
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Spain
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State/province [26]
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Barcelona
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Country [27]
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Spain
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State/province [27]
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Madrid
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Country [28]
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Taiwan
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State/province [28]
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Taipei
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Country [29]
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Taiwan
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State/province [29]
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Taichung
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Country [30]
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Taiwan
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State/province [30]
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Tainan
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genmab
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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AbbVie
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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 previously untreated 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 4 groups, called treatment arms. Each group receives a different
treatment. Around 1080 adult participants with previously untreated FL will be enrolled in
approximately 250 sites across the world.
Participants will receive R2 (intravenous [IV] infusion of rituximab (R) and oral capsules of
lenalidomide) alone or in combination with subcutaneous injections of epcoritamab.
Participants may also receive investigator's choice chemoimmunotherapy (CIT): IV infusion of
obinutuzumab (G) and IV injections of cyclophosphamide, IV injections of doxorubicin, IV
injections of vincristine, oral tablets of prednisone (CHOP) [G-CHOP]/ R-CHOP or G and IV
infusion of bendamustine (Benda) [G-Benda]/R-Benda. The total treatment duration will be 120
weeks.
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT06191744
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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Address
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AbbVie
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Phone
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Fax
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Email
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Contact person for public queries
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06191744
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