Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06191744
Registration number
NCT06191744
Ethics application status
Date submitted
20/12/2023
Date registered
5/01/2024
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
Query!
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)
Query!
Secondary ID [1]
0
0
2023-506906-38-00
Query!
Secondary ID [2]
0
0
M22-003
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
EPCORE™FL-2
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma (FL)
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Query!
Cancer
0
0
0
0
Query!
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Query!
Intervention/exposure
Study type
Interventional
Query!
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
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Arm A vs Arm B: Percentage of Participants who Achieve Complete Response rate at 30 months (CR30)
Query!
Assessment method [1]
0
0
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).
Query!
Timepoint [1]
0
0
Up to 30 Months
Query!
Primary outcome [2]
0
0
Arm A vs Arm B: Number of Participants with Progression-free survival (PFS)
Query!
Assessment method [2]
0
0
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Query!
Timepoint [2]
0
0
Up to 10 Years
Query!
Secondary outcome [1]
0
0
Arm A vs Arm B: Overall Survival (OS)
Query!
Assessment method [1]
0
0
OS is defined as the time from the date of randomization to the date of death of any cause.
Query!
Timepoint [1]
0
0
Up to 10 Years
Query!
Secondary outcome [2]
0
0
Arm A vs Arm B: Rate of Minimal Residual Disease (MRD) Negativity Rate
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Up to 10 Years
Query!
Secondary outcome [3]
0
0
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)
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
25 Weeks
Query!
Secondary outcome [4]
0
0
Arm A vs Arm C: Percentage of Participants who Achieve CR30
Query!
Assessment method [4]
0
0
CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
Query!
Timepoint [4]
0
0
Up to 30 Months
Query!
Secondary outcome [5]
0
0
Arm A vs Arm C: Number of Participants with PFS
Query!
Assessment method [5]
0
0
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Query!
Timepoint [5]
0
0
Up to 10 Years
Query!
Secondary outcome [6]
0
0
Arm A vs Arm C: OS
Query!
Assessment method [6]
0
0
OS is defined as the time from the date of randomization to the date of death of any cause.
Query!
Timepoint [6]
0
0
Up to 10 Years
Query!
Secondary outcome [7]
0
0
Arm A vs Arm C: Rate of MRD Negativity
Query!
Assessment method [7]
0
0
MRD negativity, defined as the absence of tumor specific molecules in whole blood and/or bone marrow in participants with FL MRD at baseline.
Query!
Timepoint [7]
0
0
Up to 10 Years
Query!
Secondary outcome [8]
0
0
Arm A vs Arm C: Percentage of Participants who Maintain PF According to EORTC QLQ-C30
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
Up to 10 Years
Query!
Secondary outcome [9]
0
0
Arm A vs Arm B: Percentage of Participants who Achieve CR30
Query!
Assessment method [9]
0
0
CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
Query!
Timepoint [9]
0
0
Up to 30 Months
Query!
Secondary outcome [10]
0
0
Arm A vs Arm C: Percentage of Participants who Achieve CR30
Query!
Assessment method [10]
0
0
CR30 will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
Query!
Timepoint [10]
0
0
Up to 30 Months
Query!
Secondary outcome [11]
0
0
Arm A vs Arm C: Number of Participants with PFS
Query!
Assessment method [11]
0
0
PFS is defined as the time from randomization until disease progression determined by Lugano 2014 criteria per investigator, or death, whichever occurs first.
Query!
Timepoint [11]
0
0
Up to 10 Years
Query!
Secondary outcome [12]
0
0
Arm A vs Arm B: Percentage of Participants with Change in CR Rate per IRC
Query!
Assessment method [12]
0
0
CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
Query!
Timepoint [12]
0
0
Up to 10 Years
Query!
Secondary outcome [13]
0
0
Arm A vs Arm C: Percentage of Participants with Change in CR Rate per IRC
Query!
Assessment method [13]
0
0
CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by IRC.
Query!
Timepoint [13]
0
0
Up to 10 Years
Query!
Secondary outcome [14]
0
0
Arm A vs Arm B: Percentage of Participants with Change in CR Rate per Investigator
Query!
Assessment method [14]
0
0
CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
Query!
Timepoint [14]
0
0
Up to 10 Years
Query!
Secondary outcome [15]
0
0
Arm A vs Arm C: Percentage of Participants with Change in CR Rate per Investigator
Query!
Assessment method [15]
0
0
CR will be determined by PET-CT per Lugano 2014 criteria, as assessed by investigator.
Query!
Timepoint [15]
0
0
Up to 10 Years
Query!
Secondary outcome [16]
0
0
Arm A vs Arm B: Number of Participants with Best Overall Response (BOR) per per Investigator
Query!
Assessment method [16]
0
0
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.
Query!
Timepoint [16]
0
0
Up to 10 Years
Query!
Secondary outcome [17]
0
0
Arm A vs Arm C: Number of Participants with BOR per Investigator
Query!
Assessment method [17]
0
0
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.
Query!
Timepoint [17]
0
0
Up to 10 Years
Query!
Secondary outcome [18]
0
0
Arm A vs Arm B: Number of Participants with BOR per IRC
Query!
Assessment method [18]
0
0
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.
Query!
Timepoint [18]
0
0
Up to 10 Years
Query!
Secondary outcome [19]
0
0
Arm A vs Arm C: Number of Participants with BOR per IRC
Query!
Assessment method [19]
0
0
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.
Query!
Timepoint [19]
0
0
Up to 10 Years
Query!
Secondary outcome [20]
0
0
Arm A vs Arm B: Number of Participants with Event-free Survival (EFS) per IRC
Query!
Assessment method [20]
0
0
EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Query!
Timepoint [20]
0
0
Up to 10 Years
Query!
Secondary outcome [21]
0
0
Arm A vs Arm C: Number of Participants with EFS per IRC
Query!
Assessment method [21]
0
0
EFS is defined as the time from randomization until adverse event determined by Lugano 2014 criteria per IRC, or death, whichever occurs first.
Query!
Timepoint [21]
0
0
Up to 10 Years
Query!
Secondary outcome [22]
0
0
Arm A vs Arm B: Number of Participants with EFS per Investigator
Query!
Assessment method [22]
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.
Query!
Timepoint [22]
0
0
Up to 10 Years
Query!
Secondary outcome [23]
0
0
Arm A vs Arm C: Number of Participants with EFS per Investigator
Query!
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.
Query!
Timepoint [23]
0
0
Up to 10 Years
Query!
Secondary outcome [24]
0
0
Arm A vs Arm B: Duration of Response (DOR) per IRC
Query!
Assessment method [24]
0
0
DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
Query!
Timepoint [24]
0
0
Up to 10 Years
Query!
Secondary outcome [25]
0
0
Arm A vs Arm C: DOR per IRC
Query!
Assessment method [25]
0
0
DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
Query!
Timepoint [25]
0
0
Up to 10 Years
Query!
Secondary outcome [26]
0
0
Arm A vs Arm B: DOR per Investigator
Query!
Assessment method [26]
0
0
DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
Query!
Timepoint [26]
0
0
Up to 10 Years
Query!
Secondary outcome [27]
0
0
Arm A vs Arm C: DOR per Investigator
Query!
Assessment method [27]
0
0
DOR is defined as the time from PR or CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
Query!
Timepoint [27]
0
0
Up to 10 Years
Query!
Secondary outcome [28]
0
0
Arm A vs Arm B: Duration of Complete Response (DOCR) per IRC
Query!
Assessment method [28]
0
0
DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
Query!
Timepoint [28]
0
0
Up to 10 Years
Query!
Secondary outcome [29]
0
0
Arm A vs Arm C: DOCR per IRC
Query!
Assessment method [29]
0
0
DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by IRC.
Query!
Timepoint [29]
0
0
Up to 10 Years
Query!
Secondary outcome [30]
0
0
Arm A vs Arm B: DOCR per Investigator
Query!
Assessment method [30]
0
0
DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
Query!
Timepoint [30]
0
0
Up to 10 Years
Query!
Secondary outcome [31]
0
0
Arm A vs Arm C: DOCR per Investigator
Query!
Assessment method [31]
0
0
DOCR is defined as the time from CR to disease progression per Lugano 2014 criteria, as assessed by investigator.
Query!
Timepoint [31]
0
0
Up to 10 Years
Query!
Secondary outcome [32]
0
0
Arm A vs Arm B: Time to Next Anti-lymphoma Therapy (TTNT)
Query!
Assessment method [32]
0
0
TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy
Query!
Timepoint [32]
0
0
Up to 10 Years
Query!
Secondary outcome [33]
0
0
Arm A vs Arm C: TTNT
Query!
Assessment method [33]
0
0
TTNT is defined as the time from randomization to first documented administration of subsequent anti-lymphoma therapy
Query!
Timepoint [33]
0
0
Up to 10 Years
Query!
Secondary outcome [34]
0
0
Arm A vs Arm B: Time to Progression per IRC
Query!
Assessment method [34]
0
0
Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.
Query!
Timepoint [34]
0
0
Up to 10 Years
Query!
Secondary outcome [35]
0
0
Arm A vs Arm C: Time to Progression per IRC
Query!
Assessment method [35]
0
0
Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by IRC.
Query!
Timepoint [35]
0
0
Up to 10 Years
Query!
Secondary outcome [36]
0
0
Arm A vs Arm B: Time to Progression per Investigator
Query!
Assessment method [36]
0
0
Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.
Query!
Timepoint [36]
0
0
Up to 10 Years
Query!
Secondary outcome [37]
0
0
Arm A vs Arm C: Time to Progression per Investigator
Query!
Assessment method [37]
0
0
Time to progression defined as the time from randomization to disease progression per Lugano 2014 criteria, as assessed by investigator.
Query!
Timepoint [37]
0
0
Up to 10 Years
Query!
Secondary outcome [38]
0
0
Arm A vs Arm B: Number of Participants with Progression-free Survival After Subsequent Anti-Lymphoma Therapy (PFS2)
Query!
Assessment method [38]
0
0
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.
Query!
Timepoint [38]
0
0
Up to 10 Years
Query!
Secondary outcome [39]
0
0
Arm A vs Arm C: Number of Participants with PFS2
Query!
Assessment method [39]
0
0
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.
Query!
Timepoint [39]
0
0
Up to 10 Years
Query!
Secondary outcome [40]
0
0
Arm A vs Arm B: Change in Tolerability as Measured by Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
Query!
Assessment method [40]
0
0
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.
Query!
Timepoint [40]
0
0
Up to 10 Years
Query!
Secondary outcome [41]
0
0
Arm A vs Arm C: Change in Tolerability as Measured by PRO-CTCAE
Query!
Assessment method [41]
0
0
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.
Query!
Timepoint [41]
0
0
Up to 10 Years
Query!
Secondary outcome [42]
0
0
Arm A vs Arm B: Change in Tolerability as Measured by The Functional Assessment of Cancer Therapy Singly Item - GP5 (FACT-GP5)
Query!
Assessment method [42]
0
0
The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.
Query!
Timepoint [42]
0
0
Up to 10 Years
Query!
Secondary outcome [43]
0
0
Arm A vs Arm C: Change in Tolerability as Measured by FACT-GP5
Query!
Assessment method [43]
0
0
The FACT-GP5 is a single question asking if participant is bothered by side effects of treatment.
Query!
Timepoint [43]
0
0
Up to 10 Years
Query!
Secondary outcome [44]
0
0
Arm A vs Arm B: Change in Symptoms as Measured by The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym)
Query!
Assessment method [44]
0
0
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.
Query!
Timepoint [44]
0
0
Up to 10 Years
Query!
Secondary outcome [45]
0
0
Arm A vs Arm C: Change in Symptoms as Measured by FACT-Lym
Query!
Assessment method [45]
0
0
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.
Query!
Timepoint [45]
0
0
Up to 10 Years
Query!
Secondary outcome [46]
0
0
Arm A vs Arm B: Change in Quality of Life (QoL) as Measured by FACT-Lym
Query!
Assessment method [46]
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.
Query!
Timepoint [46]
0
0
Up to 10 Years
Query!
Secondary outcome [47]
0
0
Arm A vs Arm C: Change in QoL as Measured by FACT-Lym
Query!
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.
Query!
Timepoint [47]
0
0
Up to 10 Years
Query!
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]
Query!
Assessment method [48]
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.
Query!
Timepoint [48]
0
0
Up to 10 Years
Query!
Secondary outcome [49]
0
0
Arm A vs Arm C: Change in QoL as Measured by EQ-5D-5L
Query!
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.
Query!
Timepoint [49]
0
0
Up to 10 Years
Query!
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)
Query!
Assessment method [50]
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.
Query!
Timepoint [50]
0
0
Up to 10 Years
Query!
Secondary outcome [51]
0
0
Arm A vs Arm C: Change in Participant Belief in in Efficacy of Treatment as Measured by PGIC
Query!
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.
Query!
Timepoint [51]
0
0
Up to 10 Years
Query!
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)
Query!
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.
Query!
Timepoint [52]
0
0
Up to 10 Years
Query!
Secondary outcome [53]
0
0
Arm A vs Arm C: Change in Participant Belief in in Efficacy of Treatment as Measured by PGIS
Query!
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.
Query!
Timepoint [53]
0
0
Up to 10 Years
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Had major surgery within 4 weeks prior to randomization.
* Have active cytomegalovirus (CMV) disease.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
5/02/2024
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
18/05/2037
Query!
Actual
Query!
Sample size
Target
1080
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Query!
Recruitment hospital [1]
0
0
Peter MacCallum Cancer Center /ID# 260431 - Melbourne
Query!
Recruitment hospital [2]
0
0
Westmead Hospital /ID# 261465 - Westmead
Query!
Recruitment hospital [3]
0
0
Townsville University Hospital /ID# 259323 - Douglas
Query!
Recruitment hospital [4]
0
0
Princess Alexandra Hospital /ID# 259329 - Woolloongabba
Query!
Recruitment hospital [5]
0
0
Peninsula Private Hospital /ID# 259325 - Frankston
Query!
Recruitment hospital [6]
0
0
Royal Perth Hospital /ID# 259319 - Perth
Query!
Recruitment postcode(s) [1]
0
0
3000 - Melbourne
Query!
Recruitment postcode(s) [2]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [3]
0
0
4814 - Douglas
Query!
Recruitment postcode(s) [4]
0
0
4102 - Woolloongabba
Query!
Recruitment postcode(s) [5]
0
0
3199 - Frankston
Query!
Recruitment postcode(s) [6]
0
0
6000 - Perth
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Florida
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Idaho
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Illinois
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Iowa
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kentucky
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Missouri
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Montana
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Nebraska
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
New York
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Ohio
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
South Carolina
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Texas
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Washington
Query!
Country [16]
0
0
Belgium
Query!
State/province [16]
0
0
Limburg
Query!
Country [17]
0
0
Croatia
Query!
State/province [17]
0
0
Grad Zagreb
Query!
Country [18]
0
0
Croatia
Query!
State/province [18]
0
0
Primorsko-goranska Zupanija
Query!
Country [19]
0
0
Croatia
Query!
State/province [19]
0
0
Splitsko-dalmatinska Zupanija
Query!
Country [20]
0
0
Croatia
Query!
State/province [20]
0
0
Zadar
Query!
Country [21]
0
0
Czechia
Query!
State/province [21]
0
0
Praha 17
Query!
Country [22]
0
0
Czechia
Query!
State/province [22]
0
0
Praha
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Haute-Corse
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Loire-Atlantique
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Rhone
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Sarthe
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Caen
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Paris
Query!
Country [29]
0
0
Germany
Query!
State/province [29]
0
0
Baden-Wuerttemberg
Query!
Country [30]
0
0
Germany
Query!
State/province [30]
0
0
Hessen
Query!
Country [31]
0
0
Germany
Query!
State/province [31]
0
0
Rheinland-Pfalz
Query!
Country [32]
0
0
Germany
Query!
State/province [32]
0
0
Magdeburg
Query!
Country [33]
0
0
Hungary
Query!
State/province [33]
0
0
Vas
Query!
Country [34]
0
0
Israel
Query!
State/province [34]
0
0
H_efa
Query!
Country [35]
0
0
Israel
Query!
State/province [35]
0
0
HaDarom
Query!
Country [36]
0
0
Israel
Query!
State/province [36]
0
0
HaMerkaz
Query!
Country [37]
0
0
Israel
Query!
State/province [37]
0
0
Tel-Aviv
Query!
Country [38]
0
0
Israel
Query!
State/province [38]
0
0
Yerushalayim
Query!
Country [39]
0
0
Italy
Query!
State/province [39]
0
0
Torino
Query!
Country [40]
0
0
Italy
Query!
State/province [40]
0
0
Palermo
Query!
Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Fukuoka
Query!
Country [42]
0
0
Korea, Republic of
Query!
State/province [42]
0
0
Gyeonggido
Query!
Country [43]
0
0
Korea, Republic of
Query!
State/province [43]
0
0
Seoul Teugbyeolsi
Query!
Country [44]
0
0
Netherlands
Query!
State/province [44]
0
0
Noord-Brabant
Query!
Country [45]
0
0
Netherlands
Query!
State/province [45]
0
0
Zuid-Holland
Query!
Country [46]
0
0
Netherlands
Query!
State/province [46]
0
0
Groningen
Query!
Country [47]
0
0
New Zealand
Query!
State/province [47]
0
0
Auckland
Query!
Country [48]
0
0
Poland
Query!
State/province [48]
0
0
Malopolskie
Query!
Country [49]
0
0
Poland
Query!
State/province [49]
0
0
Mazowieckie
Query!
Country [50]
0
0
Portugal
Query!
State/province [50]
0
0
Lisboa
Query!
Country [51]
0
0
Portugal
Query!
State/province [51]
0
0
Porto
Query!
Country [52]
0
0
Portugal
Query!
State/province [52]
0
0
Regiao Autonoma Da Madeira
Query!
Country [53]
0
0
Puerto Rico
Query!
State/province [53]
0
0
Rio Piedras
Query!
Country [54]
0
0
Puerto Rico
Query!
State/province [54]
0
0
San Juan
Query!
Country [55]
0
0
Romania
Query!
State/province [55]
0
0
Bucuresti
Query!
Country [56]
0
0
Romania
Query!
State/province [56]
0
0
Iasi
Query!
Country [57]
0
0
Romania
Query!
State/province [57]
0
0
Olt
Query!
Country [58]
0
0
Romania
Query!
State/province [58]
0
0
Bucharest
Query!
Country [59]
0
0
Serbia
Query!
State/province [59]
0
0
Beograd
Query!
Country [60]
0
0
Serbia
Query!
State/province [60]
0
0
Pomoravski Okrug
Query!
Country [61]
0
0
Serbia
Query!
State/province [61]
0
0
Vojvodina
Query!
Country [62]
0
0
Serbia
Query!
State/province [62]
0
0
Novi Sad
Query!
Country [63]
0
0
Spain
Query!
State/province [63]
0
0
Cantabria
Query!
Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Navarra
Query!
Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Barcelona
Query!
Country [66]
0
0
Spain
Query!
State/province [66]
0
0
Caceres
Query!
Country [67]
0
0
Spain
Query!
State/province [67]
0
0
Madrid
Query!
Country [68]
0
0
Spain
Query!
State/province [68]
0
0
Salamanca
Query!
Country [69]
0
0
Taiwan
Query!
State/province [69]
0
0
Keelung
Query!
Country [70]
0
0
Taiwan
Query!
State/province [70]
0
0
Taipei
Query!
Country [71]
0
0
Taiwan
Query!
State/province [71]
0
0
Taichung
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Genmab
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/industry
Query!
Name [1]
0
0
AbbVie
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT06191744
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
ABBVIE INC.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
ABBVIE CALL CENTER
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
844-663-3742
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
Query!
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Query!
Available to whom?
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06191744