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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06097364
Registration number
NCT06097364
Ethics application status
Date submitted
18/10/2023
Date registered
24/10/2023
Titles & IDs
Public title
A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult 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-CD20x Anti-CD3 Bispecific Antibody, Combined With Chemotherapy Versus Rituximab Combined With Chemotherapy in Previously Untreated Participants With Follicular Lymphoma (OLYMPIA-2)
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Secondary ID [1]
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0
2022-502113-28-00
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Secondary ID [2]
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0
R1979-ONC-2075
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Universal Trial Number (UTN)
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Trial acronym
OLYMPIA-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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0
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Condition category
Condition code
Cancer
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0
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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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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/Prenisolone
Experimental: Odronextamab + Chemotherapy - Part 1 of the study includes ordonextamab dose escalation for participants with previously untreated FL and relapsed/refractory FL (Part 1A only) followed by a randomized exploration of 2 regimens of odronextamab (Odro) and cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) with the objective of dose optimization (Part 1B) in previously untreated patients with FL.
Active comparator: Rituximab + Chemotherapy - In Part 2 only, participants will be randomized 1:1:1 to receive rituximab (R) with chemotherapy (CHOP), followed by rituximab monotherapy maintenance.
Experimental: Odronextamab + Chemotherapy + Maintenance - In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy \[CHOP, or cyclophosphamide, vincristine, and prednisone (CVP)\], followed by odronextamab monotherapy maintenance.
Experimental: Odronextamab + Chemotherapy + No maintenance - In Part 2, participants will be randomized 1:1:1 to receive odronextamab with chemotherapy (CHOP, or CVP) without maintenance.
Treatment: Drugs: Odronextamab
Administered by intravenous (IV) infusion
Treatment: Drugs: Rituximab
Administered by IV infusion, or subcutaneous (SC)
Treatment: Drugs: Cyclophosphamide
Administered by IV infusion
Treatment: Drugs: Doxorubicin
Administered by IV infusion
Treatment: Drugs: Vincristine
Administered by IV infusion
Treatment: Drugs: Prednisone/Prenisolone
Administered orally (PO)
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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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Incidence of dose limiting toxicities (DLTs) for odronextamab in combination with chemotherapy
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Assessment method [1]
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Part 1, DLT period
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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 in combination with chemotherapy
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Assessment method [2]
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Part 1, Treatment period
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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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Severity of TEAEs of odronextamab in combination with chemotherapy
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Assessment method [3]
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Part 1, Treatment period
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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 rate at 30 months (CR30) assessed by independent central review (ICR)
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Assessment method [4]
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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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Odronextamab concentrations in serum when administered with chemotherapy
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Assessment method [1]
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Part 1, Maintenance period and Part 2, Induction period
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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
Odronextamab concentrations in serum when administered as monotherapy
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Assessment method [2]
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0
Part 1 and Part 2, Maintenance period
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Timepoint [2]
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Up to 30 months
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Secondary outcome [3]
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0
Incidence of anti-odronextamab antibodies (ADAs)
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Assessment method [3]
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0
Part 1 and Part 2
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Timepoint [3]
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0
Up to 30 months
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Secondary outcome [4]
0
0
Titers of ADAs to odronextamab
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Assessment method [4]
0
0
Part 1 and Part 2
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Timepoint [4]
0
0
Up to 30 months
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Secondary outcome [5]
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0
Incidence of neutralizing antibodies (NAb) to odronextamab
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Assessment method [5]
0
0
Part 1 and Part 2
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Timepoint [5]
0
0
Up to 30 months
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Secondary outcome [6]
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0
Best overall response (BOR) as assessed by the investigator
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Assessment method [6]
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0
Part 1, end of Induction period and end of Maintenance period
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Timepoint [6]
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0
Up to 30 months
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Secondary outcome [7]
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0
Progression free survival (PFS) as assessed by ICR
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Assessment method [7]
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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]
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0
Change in patient reported physical functioning scale scores on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)
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Assessment method [9]
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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]
0
0
PFS as assessed by local investigator
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Assessment method [10]
0
0
Part 2
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Timepoint [10]
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Up to 5 years
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Secondary outcome [11]
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Event-free survival (EFS) as assessed by ICR
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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]
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0
EFS as assessed by 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]
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0
Overall Survival (OS)
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Assessment method [13]
0
0
Part 2
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Timepoint [13]
0
0
Up to 5 years
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Secondary outcome [14]
0
0
BOR as assessed by local investigator
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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
BOR as assessed by ICR
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Assessment method [15]
0
0
Part 2
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Timepoint [15]
0
0
Up to 30 months
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Secondary outcome [16]
0
0
Duration of response (DOR) assessed by ICR
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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
DOR as assessed by local investigator
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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
Time to next anti-lymphoma treatment (TTNT)
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Assessment method [18]
0
0
Part 2
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Timepoint [18]
0
0
Up to 5 years
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Secondary outcome [19]
0
0
Incidence 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
Severity of TEAEs
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Assessment method [20]
0
0
Part 2
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Timepoint [20]
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0
Up to 2 years
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Secondary outcome [21]
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0
Change in patient reported health related quality of life (HRQoL) as measured by EORTC-QLQ-C30
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Assessment method [21]
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 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 [21]
0
0
Up to 5 years
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Secondary outcome [22]
0
0
Change in cancer disease as measured by EORTC-QLQ-C30
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Assessment method [22]
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 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 [22]
0
0
Up to 5 years
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Secondary outcome [23]
0
0
Change in treatment related symptoms as measured by EORTC-QLQ-C30
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Assessment method [23]
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 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 [23]
0
0
Up to 5 years
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Secondary outcome [24]
0
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Change in patient-reported lymphoma disease as measured by the Lymphoma Subscale of the Functional Assessment of Cancer Treatment-Lymphoma (FACT-LymS)
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Assessment method [24]
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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 [24]
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0
Up to 5 years
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Secondary outcome [25]
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Change in treatment-related symptoms as measured by the FACT-LymS
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Assessment method [25]
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Part 2 The FACT-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 [25]
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Up to 5 years
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Secondary outcome [26]
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Change in patient-reported general health status per EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
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Assessment method [26]
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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 [26]
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0
Up to 5 years
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Secondary outcome [27]
0
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Change in patient-reported treatment side effects burden per Functional Assessment of Cancer Therapy-General Global Population Item 5 (FACT-G GP5)
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Assessment method [27]
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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 [27]
0
0
Up to 5 years
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Secondary outcome [28]
0
0
Change in Patient Global Impression of Severity (PGIS)
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Assessment method [28]
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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 [28]
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Up to 5 years
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Secondary outcome [29]
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Change in Patient Global Impression of Change (PGIC)
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Assessment method [29]
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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 [29]
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Up to 5 years
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Secondary outcome [30]
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Change in score of the FACT-G GP5 item in the patient population
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Assessment method [30]
0
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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]
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Up to 5 years
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Eligibility
Key inclusion criteria
Key
1. Have diagnosis of cluster of differentiation 20 positive (CD20+) FL grade 1-3a, stage II bulky or stage III / IV
1. For Part 1A: previously untreated participants who have Follicular Lymphoma International Prognostic Index (FLIPI)-1 score of 3 to 5, or R/R FL
2. For Part 1B: previously untreated participants who have FLIPI-1 score of 3 to 5
3. For Part 2: previously untreated participants who have FLIPI-1 score of 0 to 5
2. Have measurable disease on cross sectional imaging documented by diagnostic computed tomography [CT], or magnetic resonance imaging [MRI] imaging, as described in the protocol
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
4. Adequate bone marrow 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. Participants with central nervous system lymphoma or leptomeningeal lymphoma
2. Participants with histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
3. Participants with Waldenström macroglobulinemia (WM, lymphoplasmacytic lymphoma), grade 3b follicular lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma
4. Recent major surgery and history or organ transplantation
5. A malignancy other than NHL unless the participant is adequately and definitively treated and any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol.
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
14/11/2023
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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
29/07/2029
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Actual
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Sample size
Target
733
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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0
Calvary Mater Newcastle - Waratah
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Recruitment hospital [2]
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Pindara Private Hospital - Benowa
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Recruitment postcode(s) [1]
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0
2298 - Waratah
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Recruitment postcode(s) [2]
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4217 - Benowa
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Indiana
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Kentucky
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Michigan
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Country [4]
0
0
United States of America
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State/province [4]
0
0
New York
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Texas
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Utah
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Wisconsin
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Country [8]
0
0
Belgium
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State/province [8]
0
0
East Flanders
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Country [9]
0
0
Belgium
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State/province [9]
0
0
Liege
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Country [10]
0
0
Belgium
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State/province [10]
0
0
West Flanders
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Country [11]
0
0
Belgium
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State/province [11]
0
0
Brussels
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Country [12]
0
0
Chile
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State/province [12]
0
0
Region Metropolitana
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Country [13]
0
0
Chile
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State/province [13]
0
0
Santiago Metropolitan Region
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Country [14]
0
0
Chile
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State/province [14]
0
0
Santiago
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Country [15]
0
0
Israel
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State/province [15]
0
0
Jersualem
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Country [16]
0
0
Israel
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State/province [16]
0
0
Petah Tikva
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Country [17]
0
0
Israel
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State/province [17]
0
0
Tel Aviv
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Country [18]
0
0
Italy
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State/province [18]
0
0
Campania
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Country [19]
0
0
Italy
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State/province [19]
0
0
Emilia-Romagna
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Country [20]
0
0
Italy
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State/province [20]
0
0
Forli-Cesena
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Country [21]
0
0
Italy
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State/province [21]
0
0
Milano
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Country [22]
0
0
Italy
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State/province [22]
0
0
Udine
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Country [23]
0
0
Poland
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State/province [23]
0
0
Malopolskie
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Country [24]
0
0
Poland
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State/province [24]
0
0
Silesia
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Country [25]
0
0
Spain
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State/province [25]
0
0
Asturas
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Country [26]
0
0
Spain
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State/province [26]
0
0
Barcelona
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Country [27]
0
0
Spain
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State/province [27]
0
0
Madrid
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Country [28]
0
0
Spain
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State/province [28]
0
0
Navarre
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Country [29]
0
0
Spain
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State/province [29]
0
0
Salamanca
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Country [30]
0
0
Spain
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State/province [30]
0
0
Sevilla
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Country [31]
0
0
Spain
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State/province [31]
0
0
Terrassa
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Country [32]
0
0
Spain
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State/province [32]
0
0
Toledo
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Country [33]
0
0
Spain
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State/province [33]
0
0
Valencia
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Country [34]
0
0
Taiwan
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State/province [34]
0
0
New Taipei
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Country [35]
0
0
Taiwan
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State/province [35]
0
0
Kaohsiung
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Country [36]
0
0
Taiwan
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State/province [36]
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0
Taipei City
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Country [37]
0
0
Taiwan
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State/province [37]
0
0
Taipei
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Country [38]
0
0
Thailand
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State/province [38]
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0
Bangkok
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Country [39]
0
0
Thailand
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State/province [39]
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0
Khon Kaen
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Country [40]
0
0
Turkey
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State/province [40]
0
0
Sakarya
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Country [41]
0
0
Turkey
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State/province [41]
0
0
Ankara
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Country [42]
0
0
Turkey
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State/province [42]
0
0
Istanbul
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Country [43]
0
0
Turkey
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State/province [43]
0
0
Kayseri
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Country [44]
0
0
Turkey
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State/province [44]
0
0
Tekirdag
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Country [45]
0
0
United Kingdom
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State/province [45]
0
0
Aberdeenshire
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Country [46]
0
0
United Kingdom
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State/province [46]
0
0
Cornwall
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Country [47]
0
0
United Kingdom
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State/province [47]
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0
West Midlands
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Regeneron Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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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. Follicular lymphoma is a type of non-Hodgkin lymphoma or NHL. Participants with follicular lymphoma that has come back after treatment (called "relapsed") or did not respond to treatment (called "refractory") are eligible to take part only in Part 1A of the study. This study is made up of 3 parts: Part 1A (non-randomized), Part 1B and Part 2 (randomized - controlled). The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy to be used in Part 2 of the study. The aim of Part 2 of the study is to assess how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab 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) * The impact from the study drug on quality-of-life and ability to complete routine daily activities
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Trial website
https://clinicaltrials.gov/study/NCT06097364
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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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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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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, has made the study 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/NCT06097364