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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06091254
Registration number
NCT06091254
Ethics application status
Date submitted
13/10/2023
Date registered
19/10/2023
Titles & IDs
Public title
A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma
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Scientific title
A Phase 3, Open-label, Randomized Study to Compare the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 X Anti-CD3 Bispecific Antibody Versus Investigator's Choice in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-1)
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Secondary ID [1]
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0
2022-502660-20-00
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Secondary ID [2]
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0
R1979-HM-2298
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Universal Trial Number (UTN)
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Trial acronym
OLYMPIA-1
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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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0
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Condition category
Condition code
Cancer
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0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
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 - Odronextamab
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Doxorubicin
Treatment: Drugs - Vincristine
Treatment: Drugs - Prednisone/prednisolone
Treatment: Drugs - Bendamustine
Experimental: Odronextamab - Part 1 is a safety run-in. All participants will receive odronextamab.
In part 2 participants will be randomly assigned in a 1:1 ratio to receive odronextamab followed by odronextamab maintenance.
Active comparator: Rituximab + Investigator's Choice Chemotherapy - Part 2 only, participants will be randomized 1:1 to receive rituximab in combination with chemotherapy followed by rituximab maintenance.
Treatment: Drugs: Odronextamab
Administered by intravenous infusion (IV)
Treatment: Drugs: Rituximab
Rituximab will be administered by IV, or subcutaneously (SC)
Treatment: Drugs: Cyclophosphamide
Administered by IV as part of Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) chemotherapy, or Cyclophosphamide, Vincristine, Prednisone (CVP) chemotherapy
Treatment: Drugs: Doxorubicin
Administered by IV as part of CHOP chemotherapy
Treatment: Drugs: Vincristine
Administered by IV as part of CHOP, and CVP chemotherapy
Treatment: Drugs: Prednisone/prednisolone
Administered orally (PO) as part of CVP chemotherapy
Treatment: Drugs: Bendamustine
Administered by IV as part of chemotherapy (Rituximab-Bendamustine)
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Intervention code [1]
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0
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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0
Incidence of dose-limiting toxicities (DLTs) for odronextamab
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Assessment method [1]
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Part 1
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Timepoint [1]
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Up to 35 days
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Primary outcome [2]
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Incidence of treatment-emergent adverse events (TEAEs) of odronextamab
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Assessment method [2]
0
0
Part 1
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Timepoint [2]
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Up to 2 years
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Primary outcome [3]
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0
Severity of TEAEs of odronextamab
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Assessment method [3]
0
0
Part 1
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Timepoint [3]
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Up to 2 years
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Primary outcome [4]
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Complete Response at 30 months (CR30) as assessed by independent central review
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Assessment method [4]
0
0
Part 2
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Timepoint [4]
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Up to 30 months
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Secondary outcome [1]
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0
Concentrations of odronextamab in serum
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Assessment method [1]
0
0
Part 1
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Timepoint [1]
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Up to 30 months
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Secondary outcome [2]
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0
Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration
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Assessment method [2]
0
0
Part 1
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Timepoint [2]
0
0
Up to 30 months
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Secondary outcome [3]
0
0
Titer of ADAs to odronextamab over the study duration
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Assessment method [3]
0
0
Part 1
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Timepoint [3]
0
0
Up to 30 months
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Secondary outcome [4]
0
0
Incidence of neutralizing antibodies (NAbs) to odronextamab over the study duration
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Assessment method [4]
0
0
Part 1
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Timepoint [4]
0
0
Up to 30 months
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Secondary outcome [5]
0
0
Objective response as assessed by the investigator
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Assessment method [5]
0
0
Part 1
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Timepoint [5]
0
0
Up to 30 months
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Secondary outcome [6]
0
0
Progression-free survival (PFS) as assessed by independent central review
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Assessment method [6]
0
0
Part 2
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Timepoint [6]
0
0
Up to 5 years
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Secondary outcome [7]
0
0
Event-free survival (EFS) as assessed by independent central review
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Assessment method [7]
0
0
Part 2
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Timepoint [7]
0
0
Up to 5 years
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Secondary outcome [8]
0
0
CR30 as assessed by local investigator
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Assessment method [8]
0
0
Part 2
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Timepoint [8]
0
0
Up to 30 months
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Secondary outcome [9]
0
0
Overall mean change in physical function [European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30 (EORTC-QLQ-C30)]
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Assessment method [9]
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0
Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.
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Timepoint [9]
0
0
Up to 5 years
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Secondary outcome [10]
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0
Overall survival (OS)
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Assessment method [10]
0
0
Part 2
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Timepoint [10]
0
0
Up to 5 years
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Secondary outcome [11]
0
0
PFS as assessed by the local investigator
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Assessment method [11]
0
0
Part 2
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Timepoint [11]
0
0
Up to 5 years
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Secondary outcome [12]
0
0
EFS as assessed by the local investigator
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Assessment method [12]
0
0
Part 2
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Timepoint [12]
0
0
Up to 5 years
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Secondary outcome [13]
0
0
Objective response assessed by local investigator
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Assessment method [13]
0
0
Part 2
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Timepoint [13]
0
0
Up to 30 months
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Secondary outcome [14]
0
0
Objective response assessed by independent central review
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Assessment method [14]
0
0
Part 2
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Timepoint [14]
0
0
Up to 30 months
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Secondary outcome [15]
0
0
Duration of response (DOR) assessed by independent central review
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Assessment method [15]
0
0
Part 2
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Timepoint [15]
0
0
Up to 5 years
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Secondary outcome [16]
0
0
DOR assessed by local investigator
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Assessment method [16]
0
0
Part 2
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Timepoint [16]
0
0
Up to 5 years
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Secondary outcome [17]
0
0
Time to next anti-lymphoma treatment (TTNT)
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Assessment method [17]
0
0
Part 2
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Timepoint [17]
0
0
Up to 5 years
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Secondary outcome [18]
0
0
Incidence of TEAEs
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Assessment method [18]
0
0
Part 2
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Timepoint [18]
0
0
Up to 2 years
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Secondary outcome [19]
0
0
Severity of TEAEs
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Assessment method [19]
0
0
Part 2
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Timepoint [19]
0
0
Up to 2 years
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Secondary outcome [20]
0
0
Odronextamab concentrations in serum during the induction period
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Assessment method [20]
0
0
Part 2
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Timepoint [20]
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0
Up to 30 months
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Secondary outcome [21]
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0
Odronextamab concentrations in serum during the maintenance period
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Assessment method [21]
0
0
Part 2
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Timepoint [21]
0
0
Up to 30 months
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Secondary outcome [22]
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0
Incidence of ADAs to odronextamab over the study duration
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Assessment method [22]
0
0
Part 2
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Timepoint [22]
0
0
Up to 30 months
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Secondary outcome [23]
0
0
Titer of ADAs to odronextamab over the study duration
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Assessment method [23]
0
0
Part 2
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Timepoint [23]
0
0
Up to 30 months
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Secondary outcome [24]
0
0
Incidence of NAbs to odronextamab over the study duration
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Assessment method [24]
0
0
Part 2
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Timepoint [24]
0
0
Up to 30 months
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Secondary outcome [25]
0
0
Overall mean changes in scores of patient reported outcomes (PROs), as measured by the validated instruments EORTCQLQ- C30
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Assessment method [25]
0
0
Part 2 The EORTC QLQ-C30 includes 5 functional scales (physical, role, cognitive, emotional and social functioning), 3 symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/QoL scale, and six single items (constipation, diarrhea, insomnia, shortness of breath, appetite loss and financial difficulties). For the functioning scales and global health status / QoL, scores range from 1 = "very poor" to 7 = "excellent" with higher scores indicate better functioning; for the symptom scales, scores range from 1 = "not at all" to 4 = "very much" higher scores indicate higher symptom burden.
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Timepoint [25]
0
0
Up to 5 years
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Secondary outcome [26]
0
0
Overall mean changes in scores of PROs, as measured by the validated instruments Functional Assessment of Cancer Therapy-Lymphoma (FACT-LymS)
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Assessment method [26]
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Part 2 The FACT-Lym lymphoma subscale (LymS) includes 15 items to assess NHL-related symptoms and concerns. All questions are answered on a 5-point scale ranging from "not at all" (0) to "very much" (4). Higher scores are associated with a worse quality of life.
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Timepoint [26]
0
0
Up to 5 years
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Secondary outcome [27]
0
0
Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Severity (PGIS)
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Assessment method [27]
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Part 2 The PGIS includes a single-item to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days. Patients will choose the response that best describes the severity of their overall cancer symptoms with options on a 5-point scale ranging from 1 (No symptoms) to 4 (Very Severe).
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Timepoint [27]
0
0
Up to 5 years
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Secondary outcome [28]
0
0
Overall mean changes in scores of PROs, as measured by the validated instruments Patient Global Impression of Change (PGIC)
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Assessment method [28]
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Part 2 The PGIC item includes a single-item to assess how a patient perceives their overall change in health status since the start of study treatment. Patients will choose from response options on a 7-point scale ranging from 1 (Much Better) to 7 (Much worse); 1- Much Better, 2-Moderately Better, 3-A Little Better, 4-About the Same, 5-A Little Worse, 6-Moderately Worse, 7-Much Worse.
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Timepoint [28]
0
0
Up to 5 years
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Secondary outcome [29]
0
0
Overall mean changes in scores of PROs, as measured by the validated instruments EuroQol-5 Dimension-5 Level Scale (EQ-5D- 5L)
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Assessment method [29]
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Part 2 The EQ-5D-5L consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises the following 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 EQ VAS records the participant's self-rated health on a vertical visual analogue scale where the endpoints are labeled "Best imaginable health state" and "Worst imaginable health state".
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Timepoint [29]
0
0
Up to 5 years
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Secondary outcome [30]
0
0
Overall mean changes in scores PROs, as measured by the validated Functional Assessment of Cancer - General (FACT-G) global population 5 (GP5) question
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Assessment method [30]
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Part 2 A single item GP5 of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).
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Timepoint [30]
0
0
Up to 5 years
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Secondary outcome [31]
0
0
Change in score of the GP5 item in the participant population
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Assessment method [31]
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Part 2 A single item Global Population item 5 (GP5) of the validated FACT-G questionnaire will be used to assess from the participant perspective the overall impact of treatment side-effect. The question item is on a 5-point scale ranging from "not at all" (0) to "very much" (4).
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Timepoint [31]
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Up to 5 years
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Eligibility
Key inclusion criteria
Key
1. Diagnosis of Cluster of Differentiation 20^+ (CD20^+) FL Grade 1-3a, stage II bulky or stage III / IV
2. Need for treatment as described in the protocol
3. Have measurable disease on cross-sectional imaging documented by diagnostic imaging Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
5. Adequate bone marrow function and hepatic function
Key
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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
1. Central Nervous System (CNS) lymphoma or leptomeningeal lymphoma
2. Histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Waldenström Macroglobulinemia (WM, lymphoplasmacytic lymphoma), Grade 3b follicular lymphoma, chronic lymphocytic leukemia, or small lymphocytic lymphoma
4. Treatment with any systemic anti-lymphoma therapy
5. Infections and allergy/hypersensitivity to study drug or excipient
NOTE: Other protocol defined inclusion/exclusion criteria apply
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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
12/12/2023
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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
4/04/2029
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Actual
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Sample size
Target
478
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Icon Cancer Care, Wesley Clinic - Auchenflower
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Recruitment hospital [2]
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0
Epworth Freemasons Hospital - East Melbourne
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Recruitment hospital [3]
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0
St Vincent Hospital Melbourne - Fitzroy
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Recruitment postcode(s) [1]
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0
4065 - Auchenflower
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Recruitment postcode(s) [2]
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3002 - East Melbourne
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Recruitment postcode(s) [3]
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3065 - Fitzroy
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Arizona
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Indiana
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Michigan
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Country [5]
0
0
United States of America
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State/province [5]
0
0
New York
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Country [6]
0
0
United States of America
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State/province [6]
0
0
North Carolina
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Country [7]
0
0
United States of America
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State/province [7]
0
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Ohio
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Country [8]
0
0
United States of America
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State/province [8]
0
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Texas
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Virginia
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Country [10]
0
0
United States of America
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State/province [10]
0
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Wisconsin
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Country [11]
0
0
Austria
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State/province [11]
0
0
Linz
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Country [12]
0
0
Chile
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State/province [12]
0
0
Región Metropolitana De Santiago
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Country [13]
0
0
Chile
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State/province [13]
0
0
Santiago
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Country [14]
0
0
Chile
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State/province [14]
0
0
Las Condes
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Country [15]
0
0
Czechia
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State/province [15]
0
0
Vinohrady
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Country [16]
0
0
Czechia
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State/province [16]
0
0
Hradec Kralove 5
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Country [17]
0
0
Czechia
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State/province [17]
0
0
Praha
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Country [18]
0
0
France
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State/province [18]
0
0
Angers
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Country [19]
0
0
France
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State/province [19]
0
0
Argenteuil
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0
0
France
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Marseille
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0
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France
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0
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Nantes
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0
France
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Poitiers
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0
0
France
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State/province [23]
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0
Strasbourg
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0
0
France
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State/province [24]
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0
Tours Cedex 09
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Country [25]
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Germany
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State/province [25]
0
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Dresden
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Country [26]
0
0
Israel
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State/province [26]
0
0
Ashdod
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0
0
Israel
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State/province [27]
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0
Haifa
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Country [28]
0
0
Israel
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0
0
Jerusalem
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Country [29]
0
0
Israel
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0
Nahariya
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0
0
Israel
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State/province [30]
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0
Petah Tikva
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0
0
Israel
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State/province [31]
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0
Ramat-Gan
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Israel
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Tel-Aviv
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Italy
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State/province [33]
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Ascoli Piceno
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Italy
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Bologna
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Italy
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Brescia
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Italy
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Candiolo
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Italy
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Genova
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Italy
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Meldola
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Italy
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Milan
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Italy
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Napoli
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Italy
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Novara
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Italy
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Ravenna
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Italy
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Udine
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Poland
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Malopolskie
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Poland
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Katowice
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Poland
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Skorzewo
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Spain
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A Coruna
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0
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Spain
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0
Barcelona
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0
0
Spain
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0
Granada
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0
0
Spain
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Madrid
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0
0
Spain
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0
Malaga
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0
0
Spain
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0
0
Murcia
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0
0
Spain
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0
Oviedo
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0
0
Spain
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0
0
Palma de Mallorca
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0
0
Spain
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State/province [55]
0
0
Pamplona
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0
0
Spain
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0
0
Pozuelo de Alarcon
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0
0
Spain
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0
0
Salamanca
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0
0
Spain
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0
0
Santander
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Country [59]
0
0
Spain
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State/province [59]
0
0
Santiago De Compostela
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Country [60]
0
0
Spain
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Sevilla
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Spain
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Toledo
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Spain
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Valencia
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Switzerland
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Baden
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Switzerland
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Basel
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Switzerland
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St. Gallen
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Switzerland
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Winterthur
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Taiwan
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Changhua County
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Chiayi
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Taipei
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Taiwan
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Kaohsiung
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New Taipei
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Taipei City
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Taoyuan
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Kayseri
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Turkey
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Sakarya
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Turkey
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Tekirdag
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United Kingdom
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Devon
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United Kingdom
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Norfolk
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United Kingdom
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Glasgow
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United Kingdom
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Romford
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United Kingdom
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Truro
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Regeneron Pharmaceuticals
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Ethics approval
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Summary
Brief summary
This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin lymphoma or NHL). This study will be made up of two parts: Part 1 (non-randomized) and Part 2 (randomized - controlled). The aim of Part 1 of the study is to see how safe and tolerable the study drug is when given alone. The aim of Part 2 of the study is to see how the study drug works compared to rituximab (called the "comparator drug") and chemotherapy (the current standard of care for NHL). Standard of care means the usual medication expected and used when receiving treatment for a condition. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects) * How the study drug affects quality of life and ability to complete routine daily activities.
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Trial website
https://clinicaltrials.gov/study/NCT06091254
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Public notes
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Contacts
Principal investigator
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Clinical Trial Management
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Regeneron Pharmaceuticals
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Contact person for public queries
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Clinical Trials Administrator
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Phone
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844-734-6643
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR), Analytic code
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When will data be available (start and end dates)?
When Regeneron has :
* received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
* made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
* has the legal authority to share the data, and
* has ensured the ability to protect participant privacy
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Available to whom?
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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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/NCT06091254