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A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated (ELM-2)

Primary Purpose

B-cell Non-Hodgkin Lymphoma (NHL)

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Odronextamab
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for B-cell Non-Hodgkin Lymphoma (NHL) focused on measuring Relapsed B-NHL, Refractory B-NHL, NHL, FL, DLBCL, MZL, MCL, bispecific antibody, CD20

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
  • Disease-specific cohorts that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
  • DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol
  • MCL after BTK inhibitor therapy cohort: New enrollment is paused until further notice
  • MZL cohort: New enrollment is paused until further notice
  • Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
  • Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
  • Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate bone marrow, hepatic, and renal function as defined in the protocol

Key Exclusion Criteria:

  • Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
  • Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
  • History of allogeneic stem cell transplantation
  • Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
  • Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
  • History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
  • Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections
  • Known hypersensitivity to both allopurinol and rasburicase
  • Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Sites / Locations

  • Rush University Medical CenterRecruiting
  • University of Iowa Hospital and ClinicsRecruiting
  • Norton Cancer InstituteRecruiting
  • Beth Israel Deaconess Medical Center
  • Tufts Cancer CenterRecruiting
  • University of Michigan
  • University/Academic Hospital Mayo ClinicRecruiting
  • SSM Saint Louis University Hospital
  • John Theurer Cancer Center Hackensack University Medical CenterRecruiting
  • Morristown Medical Center
  • Weill Cornell Medical CollegeRecruiting
  • Stony Brook HospitalRecruiting
  • Wake Forest Baptist Medical CenterRecruiting
  • Cleveland ClinicRecruiting
  • Stephenson Cancer CenterRecruiting
  • Simmons Comprehensive Cancer CenterRecruiting
  • Brook Army Medical Center
  • Border Medical Oncology, Albury Wodonga Regional Cancer CentreRecruiting
  • Epworth HospitalRecruiting
  • Penninsula & South Eastern Haemotology and Oncology GroupRecruiting
  • Andrew Love Cancer CenterRecruiting
  • Olivia Newton John Cancer CentreRecruiting
  • The Tweed HospitalRecruiting
  • Royal Perth HospitalRecruiting
  • Andrew Love Cancer CenterRecruiting
  • Cross Cancer CenterRecruiting
  • QEII Health Science CenterRecruiting
  • Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)Recruiting
  • Sun Yat-Sen University Cancer Center (Cancer Prevention and Treatment Center, Sun Yat-sen University)Recruiting
  • The First Affiliated Hospital of Zhengzhou UniversityRecruiting
  • West China Hospital of Sichuan UniversityRecruiting
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
  • The Second Affiliated Hospital of Zhejiang University School of MedicineRecruiting
  • The First Affiliated Hospital, Zhejiang University School of MedicineRecruiting
  • Peking University Third HospitalRecruiting
  • Peking Union Medical College HospitalRecruiting
  • The First Bethune Hospital Of Jilin UniversityRecruiting
  • The First Affiliated Hospital of Soochow UniversityRecruiting
  • Tianjin Medical University Cancer Institute & HospitalRecruiting
  • Harbin Medical University Cancer HospitalRecruiting
  • Second Affiliated Hospital of Army Medical University, PLARecruiting
  • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting
  • Renmin Hospital of Wuhan UniversityRecruiting
  • Fudan University Cancer HospitalRecruiting
  • The First Affiliated Hospital of Xi 'an Jiaotong UniversityRecruiting
  • CHU de CaenRecruiting
  • Hospital Henri MondorRecruiting
  • Hopital Huriez-CHRU LilleRecruiting
  • CHU de NantesRecruiting
  • Hopital de la Pitie SalpetriereRecruiting
  • CHU Haut LevequeRecruiting
  • Centre Hospitalier Lyon SudRecruiting
  • Centre Hospitalier Universitaire (CHU) de PoitiersRecruiting
  • Klinikum Chemnitz gGmbH Klinik fuer Innere Medizin IIIRecruiting
  • University Hospital Halle SaaleRecruiting
  • Kliniken Ostalb, StauferklinikumRecruiting
  • Klinik fur Innere Medizin II Schwarzwald Baar KlinikumRecruiting
  • Universitätsklinikum WürzburgRecruiting
  • Policlinico Sant'Orsola MalpipghiRecruiting
  • Azienda Ospedaliera CareggiRecruiting
  • Ospedale Di Livorno Usl6Recruiting
  • Fondazione IRCCS Ca' Grande Ospedale Maggiore PoliclinicoRecruiting
  • ASST Grande Ospedale Metropolitano NiguardaRecruiting
  • AOU Maggiore della CaritaRecruiting
  • Santa Maria Della Misericordia HospitalRecruiting
  • Ospedale Santa Maria delle CrociRecruiting
  • SC Ematologia Dip to Oncologico e Tecnologie Avanzate_ IRCCS - Arcispedale Santa Maria NuovaRecruiting
  • Struttura Complessa di Ematologia e Trapianto di cellule staminali emopoietiche _ IRCCS Casa Sollievo della SofferenzaRecruiting
  • A.O. Santa MariaRecruiting
  • Ospedale dell'AngeloRecruiting
  • Ospedale DellAngelo Di Mestre Umberto IRecruiting
  • National Hospital Organization Nagoya Medical CenterRecruiting
  • Japanese Red Cross Aichi Medical Center Nagoya Daini HospitalRecruiting
  • National Cancer Center Hospital EastRecruiting
  • National Hospital Organization Shikoku Cancer CenterRecruiting
  • National Hospital Organization National Kyushu Cancer CenterRecruiting
  • Kobe City Medical Center General HospitalRecruiting
  • " University Hospital Kyoto Prefectural University of Medicine"Recruiting
  • National Cancer Center HospitalRecruiting
  • Tokai University HospitalRecruiting
  • Saitama Medical University International Medical CenterRecruiting
  • Japanese Red Cross Nagasaki Genbaku HospitalRecruiting
  • Osaka Metropolitan University HospitalRecruiting
  • Chiba Cancer CenterRecruiting
  • Yamagata University HospitalRecruiting
  • Dong-A University HospitalRecruiting
  • Keimyung University Dongsan Medical CenterRecruiting
  • National Cancer CenterRecruiting
  • Korea University Anam HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance HospitalRecruiting
  • Samsung Medical CenterRecruiting
  • The Catholic University of Korea, Seoul St. Mary's HospitalRecruiting
  • Ewha Womans University Mokdong HospitalRecruiting
  • Ulsan University HospitalRecruiting
  • Uniwersyteckie Centrum KliniczneRecruiting
  • Szpitale Pomorskie spSp. Z.o.o.Recruiting
  • Małopolskie Centrum Medyczne S.CRecruiting
  • Regeneron Study SiteRecruiting
  • Apteka IHiT (Instytut Hematologii I TransfuzjologiiRecruiting
  • Instytut im. M. Sklodowskiej-CurieRecruiting
  • Uniwersytecki Szpital KlinicznyRecruiting
  • National University HospitalRecruiting
  • Singapore General HospitalRecruiting
  • Raffles Cancer Center
  • ICON-SOC Farrer Park HospitalRecruiting
  • Hospital Universitario Vall De'HebronRecruiting
  • Hospital Clinic I Provincial de BarcelonaRecruiting
  • Hospital de la Santa Creu I Sant PauRecruiting
  • Hospital Universitario Donostia
  • Institut Català d'OncologiaRecruiting
  • MD Anderson Cancer CenterRecruiting
  • Fundacion Jimenez Diaz University HospitalRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario HM SanchinarroRecruiting
  • Hospital Universitario Quiron Salud MadridRecruiting
  • Hospital Costa del SolRecruiting
  • Hospital son LlatzerRecruiting
  • Hospital Son EspasesRecruiting
  • Hospital Universitario de SalamancaRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Kaosiung Chang Gung Memorial HospitalRecruiting
  • Taipei Medical University - Shuang-Ho HospitalRecruiting
  • China Medical University HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • Chi-Mei Medical Center-LiuyingRecruiting
  • National Taiwan University HospitalRecruiting
  • Mackay Memorial HospitalRecruiting
  • Koo Foundation Sun Yat Sen Cancer CenterRecruiting
  • Tri-Service General HospitalRecruiting
  • Chang Gung Memorial HospitalRecruiting
  • University Hospital of WalesRecruiting
  • Western General Hospital
  • Kings College HospitalRecruiting
  • Derriford HospitalRecruiting
  • The Royal Marsden HospitalRecruiting
  • Royal Cornwall HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

FL

DLBCL

MCL

MZL

Other B-NHL

Arm Description

Follicular lymphoma grade 1-3a cohort

Diffuse large B-cell lymphoma cohort

Mantle Cell Lymphoma cohort

Marginal Zone Lymphoma cohort

Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia [WM]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed

Outcomes

Primary Outcome Measures

ORR (FL grade 1-3a/MZL)
For each of the 5 disease-specific cohorts according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.
ORR (DLBCL/MCL/Other B-NHL)
For each of the 5 disease-specific cohorts according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.

Secondary Outcome Measures

ORR (FL/MZL)
According to the Lugano Classification, as assessed by local investigator evaluation
ORR (DLBCL/MCL/Other B-NHL)
According to the Lugano Classification, as assessed by local investigator evaluation
CR rate (FL grade 1-3a/MZL)
According to the Lugano Classification and as assessed by local investigator evaluation and independent central review
CR rate (DLBCL/MCL/Other B-NHL)
According to the Lugano Classification and as assessed by local investigator evaluation and independent central review
PFS
According to the Lugano Classification and as assessed by independent central review and local investigator evaluation
OS
DOR
According to the Lugano Classification and as assessed by independent central review and local investigator evaluation
DCR (FL grade 1-3a/MZL)
According to the Lugano Classification and as assessed by independent central review and local investigator evaluation
DCR (DLBCL/MCL/Other B-NHL)
According to the Lugano Classification and as assessed by independent central review and local investigator evaluation
Incidence and severity of treatment emergent adverse events (TEAEs)
Pharmacokinetics: Concentration of odronextamab
End of infusion [EOI]; Concentration at a specified time t [Ct])
Incidence of anti-drug antibodies (ADA) to odronextamab over time
Titer of anti-drug antibodies to odronextamab over time
Incidence of neutralizing antibodies (Nab) to odronextamab over time
Changes in scores of patient-reported outcomes as measured by EORTC QLQ-C30
EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).
Changes in scores of patient-reported outcomes as measured by FACT-Lym
Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS).
Changes in scores of patient-reported outcomes as measured by EQ-5D-3L
The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.

Full Information

First Posted
March 14, 2019
Last Updated
April 18, 2023
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03888105
Brief Title
A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated
Acronym
ELM-2
Official Title
An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an Anti CD20 x Anti-CD3 Bispecific Antibody, in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 13, 2019 (Actual)
Primary Completion Date
December 19, 2025 (Anticipated)
Study Completion Date
February 5, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups: In patients with follicular lymphoma (FL) grade 1-3a *1,2 In patients with diffuse large B-cell lymphoma (DLBCL) *1,2 In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy. In patients with marginal zone lymphoma (MZL) *1 In patients with other B-NHL subtypes *1 Secondary objectives are: To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by: ORR according to the Lugano Classification and as assessed by local investigator evaluation Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review Progression-free survival (PFS)*3 Overall survival (OS) Duration of response (DOR)*3 Disease control rate (DCR)*3 To evaluate the safety and tolerability of odronextamab To assess the pharmacokinetics (PK) of odronextamab To assess the immunogenicity of odronextamab To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L) 1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy 2 including an anti-CD20 antibody and an alkylating agent 3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Non-Hodgkin Lymphoma (NHL)
Keywords
Relapsed B-NHL, Refractory B-NHL, NHL, FL, DLBCL, MZL, MCL, bispecific antibody, CD20

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
5 cohorts The first 68 patients in the DLBCL cohort will be randomized; the remaining patients will not be randomized
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
512 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FL
Arm Type
Experimental
Arm Description
Follicular lymphoma grade 1-3a cohort
Arm Title
DLBCL
Arm Type
Experimental
Arm Description
Diffuse large B-cell lymphoma cohort
Arm Title
MCL
Arm Type
Experimental
Arm Description
Mantle Cell Lymphoma cohort
Arm Title
MZL
Arm Type
Experimental
Arm Description
Marginal Zone Lymphoma cohort
Arm Title
Other B-NHL
Arm Type
Experimental
Arm Description
Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia [WM]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed
Intervention Type
Drug
Intervention Name(s)
Odronextamab
Other Intervention Name(s)
REGN1979
Intervention Description
Administered by intravenous (IV) infusion
Primary Outcome Measure Information:
Title
ORR (FL grade 1-3a/MZL)
Description
For each of the 5 disease-specific cohorts according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.
Time Frame
From first patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study
Title
ORR (DLBCL/MCL/Other B-NHL)
Description
For each of the 5 disease-specific cohorts according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.
Time Frame
From first patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study
Secondary Outcome Measure Information:
Title
ORR (FL/MZL)
Description
According to the Lugano Classification, as assessed by local investigator evaluation
Time Frame
First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study.
Title
ORR (DLBCL/MCL/Other B-NHL)
Description
According to the Lugano Classification, as assessed by local investigator evaluation
Time Frame
First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study.
Title
CR rate (FL grade 1-3a/MZL)
Description
According to the Lugano Classification and as assessed by local investigator evaluation and independent central review
Time Frame
First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study.
Title
CR rate (DLBCL/MCL/Other B-NHL)
Description
According to the Lugano Classification and as assessed by local investigator evaluation and independent central review
Time Frame
First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study.
Title
PFS
Description
According to the Lugano Classification and as assessed by independent central review and local investigator evaluation
Time Frame
First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Title
OS
Time Frame
First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Title
DOR
Description
According to the Lugano Classification and as assessed by independent central review and local investigator evaluation
Time Frame
First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Title
DCR (FL grade 1-3a/MZL)
Description
According to the Lugano Classification and as assessed by independent central review and local investigator evaluation
Time Frame
First patient first dose until all patients have completed 52 weeks of study treatment or have withdrawn from the study.
Title
DCR (DLBCL/MCL/Other B-NHL)
Description
According to the Lugano Classification and as assessed by independent central review and local investigator evaluation
Time Frame
First patient first dose until all patients have completed 36 weeks of study treatment or have withdrawn from the study.
Title
Incidence and severity of treatment emergent adverse events (TEAEs)
Time Frame
First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Title
Pharmacokinetics: Concentration of odronextamab
Description
End of infusion [EOI]; Concentration at a specified time t [Ct])
Time Frame
12 weeks following end of treatment
Title
Incidence of anti-drug antibodies (ADA) to odronextamab over time
Time Frame
12 weeks following end of treatment
Title
Titer of anti-drug antibodies to odronextamab over time
Time Frame
12 weeks following end of treatment
Title
Incidence of neutralizing antibodies (Nab) to odronextamab over time
Time Frame
12 weeks following end of treatment
Title
Changes in scores of patient-reported outcomes as measured by EORTC QLQ-C30
Description
EORTC QLQ-C30 is a self-reported, 30-item generic questionnaire developed to assess 15 domains: global health status scale, five functional scales (physical, role, emotional, cognitive, and social functioning) and nine symptom scales (fatigue, nausea, vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties).
Time Frame
First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Title
Changes in scores of patient-reported outcomes as measured by FACT-Lym
Description
Composed of the FACT-G plus the 15-item Lymphoma Subscale (LymS).
Time Frame
First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose
Title
Changes in scores of patient-reported outcomes as measured by EQ-5D-3L
Description
The EQ-5D-3L is a standardized instrument for use as a measure of health outcome. It is a health questionnaire that consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
Time Frame
First patient first dose to disease progression or death due to any cause, whichever comes first, approximately 194 weeks following the first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the "other B-NHL" cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017). Disease-specific cohorts that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol MCL after BTK inhibitor therapy cohort: New enrollment is paused until further notice MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy. Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma. Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Adequate bone marrow, hepatic, and renal function as defined in the protocol Key Exclusion Criteria: Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI). Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter. History of allogeneic stem cell transplantation Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections Known hypersensitivity to both allopurinol and rasburicase Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy Note: Other protocol-defined Inclusion/Exclusion criteria apply
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Trials Administrator
Phone
844-734-6643
Email
clinicaltrials@regeneron.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Iowa Hospital and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Name
Norton Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Individual Site Status
Recruiting
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Tufts Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02332
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Terminated
Facility Name
University/Academic Hospital Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Name
SSM Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Terminated
Facility Name
John Theurer Cancer Center Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Individual Site Status
Terminated
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Name
Stony Brook Hospital
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Individual Site Status
Recruiting
Facility Name
Wake Forest Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
Simmons Comprehensive Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Brook Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Terminated
Facility Name
Border Medical Oncology, Albury Wodonga Regional Cancer Centre
City
East Albury
ZIP/Postal Code
NSW 2640
Country
Australia
Individual Site Status
Recruiting
Facility Name
Epworth Hospital
City
East Melbourne
ZIP/Postal Code
VIC 3002
Country
Australia
Individual Site Status
Recruiting
Facility Name
Penninsula & South Eastern Haemotology and Oncology Group
City
Frankston
ZIP/Postal Code
VIC 3199
Country
Australia
Individual Site Status
Recruiting
Facility Name
Andrew Love Cancer Center
City
Geelong
ZIP/Postal Code
VIC 3220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Olivia Newton John Cancer Centre
City
Heidelberg
ZIP/Postal Code
VIC 3084
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Tweed Hospital
City
Murdoch
ZIP/Postal Code
NSW 2485
Country
Australia
Individual Site Status
Recruiting
Facility Name
Royal Perth Hospital
City
Perth
ZIP/Postal Code
6000
Country
Australia
Individual Site Status
Recruiting
Facility Name
Andrew Love Cancer Center
City
Tweed Heads
ZIP/Postal Code
VIC3220
Country
Australia
Individual Site Status
Recruiting
Facility Name
Cross Cancer Center
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G172
Country
Canada
Individual Site Status
Recruiting
Facility Name
QEII Health Science Center
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Peking University Cancer Hospital (Beijing Cancer Hospital) (Beijing Institute for Cancer Research)
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Name
Sun Yat-Sen University Cancer Center (Cancer Prevention and Treatment Center, Sun Yat-sen University)
City
Guanngzhou City
State/Province
Guangdong
ZIP/Postal Code
150060
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou City
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
City
Qiaokou District
State/Province
Wuhan Hubei Province
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310052
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, Zhejiang University School of Medicine
City
Shangcheng District Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Name
Peking University Third Hospital
City
Beijing City Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Recruiting
Facility Name
Peking Union Medical College Hospital
City
Beijing City, Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Name
The First Bethune Hospital Of Jilin University
City
Chaoyang District Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Soochow University
City
Gusu District Suzhou
ZIP/Postal Code
215031
Country
China
Individual Site Status
Recruiting
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
HeXi District Tianjin City
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Name
Harbin Medical University Cancer Hospital
City
Nangang District Harbin Heilongjiang
ZIP/Postal Code
150000
Country
China
Individual Site Status
Recruiting
Facility Name
Second Affiliated Hospital of Army Medical University, PLA
City
Shapingba District Chongqing
ZIP/Postal Code
400000
Country
China
Individual Site Status
Recruiting
Facility Name
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
City
Tianjin City Tianjin
ZIP/Postal Code
300020
Country
China
Individual Site Status
Recruiting
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan Hubei Province
ZIP/Postal Code
430060
Country
China
Individual Site Status
Recruiting
Facility Name
Fudan University Cancer Hospital
City
Xuhui District Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital of Xi 'an Jiaotong University
City
Yanta District Xi'an Shanxi
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14 000
Country
France
Individual Site Status
Recruiting
Facility Name
Hospital Henri Mondor
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Huriez-CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital de la Pitie Salpetriere
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Name
CHU Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Bénite
ZIP/Postal Code
69310
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire (CHU) de Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Recruiting
Facility Name
Klinikum Chemnitz gGmbH Klinik fuer Innere Medizin III
City
Chemnitz
ZIP/Postal Code
09116
Country
Germany
Individual Site Status
Recruiting
Facility Name
University Hospital Halle Saale
City
Halle
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Kliniken Ostalb, Stauferklinikum
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Individual Site Status
Recruiting
Facility Name
Klinik fur Innere Medizin II Schwarzwald Baar Klinikum
City
Villingen-Schwenningen
ZIP/Postal Code
78052
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Würzburg
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Policlinico Sant'Orsola Malpipghi
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Careggi
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Di Livorno Usl6
City
Livorno
ZIP/Postal Code
57124
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Ca' Grande Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
AOU Maggiore della Carita
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Santa Maria Della Misericordia Hospital
City
Perugia
ZIP/Postal Code
06129
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Santa Maria delle Croci
City
Ravenna
ZIP/Postal Code
48121
Country
Italy
Individual Site Status
Recruiting
Facility Name
SC Ematologia Dip to Oncologico e Tecnologie Avanzate_ IRCCS - Arcispedale Santa Maria Nuova
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Struttura Complessa di Ematologia e Trapianto di cellule staminali emopoietiche _ IRCCS Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Santa Maria
City
Terni
ZIP/Postal Code
05100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale dell'Angelo
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale DellAngelo Di Mestre Umberto I
City
Venice
ZIP/Postal Code
30174
Country
Italy
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Nagoya Medical Center
City
Nagoya
State/Province
Aiti
ZIP/Postal Code
460-0001
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
City
Nagoya
State/Province
Aiti
ZIP/Postal Code
466-8650
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital East
City
Kashiwa-shi
State/Province
Chiba-ken
ZIP/Postal Code
277-8577
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Shikoku Cancer Center
City
Matsuyama
State/Province
Ehime
ZIP/Postal Code
791-0280
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization National Kyushu Cancer Center
City
Fukuoka-shi
State/Province
Hukuoka
ZIP/Postal Code
811-1395
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kobe City Medical Center General Hospital
City
Kobe
State/Province
Hyōgo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
" University Hospital Kyoto Prefectural University of Medicine"
City
Kyoto City
State/Province
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Cancer Center Hospital
City
Chuo ku
ZIP/Postal Code
104-0045
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokai University Hospital
City
Isehara-Shi
ZIP/Postal Code
259-1193
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Medical University International Medical Center
City
L'Hospitalet De Llobregat
ZIP/Postal Code
350-1298
Country
Japan
Individual Site Status
Recruiting
Facility Name
Japanese Red Cross Nagasaki Genbaku Hospital
City
Nagasaki
ZIP/Postal Code
852-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Metropolitan University Hospital
City
Osaka City
ZIP/Postal Code
545-8586
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba Cancer Center
City
Tiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Recruiting
Facility Name
Yamagata University Hospital
City
Yamagata City
ZIP/Postal Code
990-9585
Country
Japan
Individual Site Status
Recruiting
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu-si
ZIP/Postal Code
41931
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
National Cancer Center
City
Goyang-si
ZIP/Postal Code
10408
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
ZIP/Postal Code
07985
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Ulsan University Hospital
City
Ulsan
ZIP/Postal Code
44033
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdańsk
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Name
Szpitale Pomorskie spSp. Z.o.o.
City
Gdynia
ZIP/Postal Code
81-519
Country
Poland
Individual Site Status
Recruiting
Facility Name
Małopolskie Centrum Medyczne S.C
City
Krakow
ZIP/Postal Code
30-510
Country
Poland
Individual Site Status
Recruiting
Facility Name
Regeneron Study Site
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
Apteka IHiT (Instytut Hematologii I Transfuzjologii
City
Warszawa
ZIP/Postal Code
00-791
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut im. M. Sklodowskiej-Curie
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny
City
Wrocław
ZIP/Postal Code
50-367
Country
Poland
Individual Site Status
Recruiting
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Raffles Cancer Center
City
Singapore
ZIP/Postal Code
188770
Country
Singapore
Individual Site Status
Completed
Facility Name
ICON-SOC Farrer Park Hospital
City
Singapore
ZIP/Postal Code
217562
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall De'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de la Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Donostia
City
Donostia
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Suspended
Facility Name
Institut Català d'Oncologia
City
L'Hospitalet de llobregat
ZIP/Postal Code
08908
Country
Spain
Individual Site Status
Recruiting
Facility Name
MD Anderson Cancer Center
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Individual Site Status
Recruiting
Facility Name
Fundacion Jimenez Diaz University Hospital
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Quiron Salud Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Costa del Sol
City
Marbella
ZIP/Postal Code
29603
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital son Llatzer
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Son Espases
City
Palma
ZIP/Postal Code
07120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaosiung Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
833
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Medical University - Shuang-Ho Hospital
City
New Taipei City
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
China Medical University Hospital
City
Taichung City
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan City
ZIP/Postal Code
702
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chi-Mei Medical Center-Liuying
City
Tainan
ZIP/Postal Code
736
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei City
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Mackay Memorial Hospital
City
Taipei City
ZIP/Postal Code
10449
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Koo Foundation Sun Yat Sen Cancer Center
City
Taipei City
ZIP/Postal Code
11251
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital
City
Taipei City
ZIP/Postal Code
114
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
University Hospital of Wales
City
Cardiff
ZIP/Postal Code
CF14 4XW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Individual Site Status
Terminated
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8DH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
The Royal Marsden Hospital
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
IPD Sharing Access Criteria
Qualified researchers may request access to anonymized patient level data or aggregate study data 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 the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).
IPD Sharing URL
https://vivli.org/

Learn more about this trial

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With B-cell Non-Hodgkin Lymphoma That Have Been Previously Treated

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