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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03888105




Registration number
NCT03888105
Ethics application status
Date submitted
14/03/2019
Date registered
25/03/2019

Titles & IDs
Public title
A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies
Scientific 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
Secondary ID [1] 0 0
2017-002139-41
Secondary ID [2] 0 0
R1979-ONC-1625
Universal Trial Number (UTN)
Trial acronym
ELM-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Non-Hodgkin Lymphoma (B-NHL) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Odronextamab

Experimental: FL - Follicular lymphoma grade 1-3a cohort

Experimental: DLBCL - Diffuse large B-cell lymphoma cohort

Experimental: MCL - Mantle Cell Lymphoma cohort

Experimental: MZL - Marginal Zone Lymphoma cohort

Experimental: Other B-NHL - 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


Treatment: Drugs: Odronextamab
Administered by intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR), as assessed by independent central review
Timepoint [1] 0 0
Up to 52 weeks of study treatment
Primary outcome [2] 0 0
ORR, as assessed by independent central review
Timepoint [2] 0 0
Up to 36 weeks of study treatment
Secondary outcome [1] 0 0
ORR, as assessed by the local investigator
Timepoint [1] 0 0
Up to 52 weeks of study treatment
Secondary outcome [2] 0 0
ORR, as assessed by the local investigator
Timepoint [2] 0 0
Up to 36 weeks of study treatment
Secondary outcome [3] 0 0
Complete response (CR) rate, as assessed by the local investigator
Timepoint [3] 0 0
Up to 52 weeks of study treatment
Secondary outcome [4] 0 0
CR rate, as assessed by independent central review
Timepoint [4] 0 0
Up to 52 weeks of study treatment
Secondary outcome [5] 0 0
CR rate, as assessed by the local investigator
Timepoint [5] 0 0
Up to 36 weeks of study treatment
Secondary outcome [6] 0 0
CR rate, as assessed by independent central review
Timepoint [6] 0 0
Up to 36 weeks of study treatment
Secondary outcome [7] 0 0
Progression-free survival (PFS), as assessed by independent central review
Timepoint [7] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [8] 0 0
PFS, as assessed by the local investigator
Timepoint [8] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [9] 0 0
Overall survival (OS)
Timepoint [9] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [10] 0 0
Duration of response (DOR), as assessed by independent central review
Timepoint [10] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [11] 0 0
DOR, as assessed by the local investigator
Timepoint [11] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [12] 0 0
Disease control rate (DCR), as assessed by independent central review
Timepoint [12] 0 0
Up to 52 weeks of study treatment
Secondary outcome [13] 0 0
DCR, as assessed by the local ivestigator
Timepoint [13] 0 0
Up to 52 weeks of study treatment
Secondary outcome [14] 0 0
DCR, as assessed by independent central review
Timepoint [14] 0 0
Up to 36 weeks of study treatment
Secondary outcome [15] 0 0
DCR, as assessed by the local investigator
Timepoint [15] 0 0
Up to 36 weeks of study treatment
Secondary outcome [16] 0 0
Incidence and severity of treatment emergent adverse events (TEAEs)
Timepoint [16] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [17] 0 0
Concentration of odronextamab
Timepoint [17] 0 0
12 weeks following end of treatment
Secondary outcome [18] 0 0
Incidence of anti-drug antibodies (ADA) to odronextamab over time
Timepoint [18] 0 0
12 weeks following end of treatment
Secondary outcome [19] 0 0
Titer of anti-drug antibodies to odronextamab over time
Timepoint [19] 0 0
12 weeks following end of treatment
Secondary outcome [20] 0 0
Incidence of neutralizing antibodies (Nab) to odronextamab over time
Timepoint [20] 0 0
12 weeks following end of treatment
Secondary outcome [21] 0 0
Changes in scores of patient-reported outcomes as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)
Timepoint [21] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [22] 0 0
Changes in scores of patient-reported outcomes as measured by Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym)
Timepoint [22] 0 0
Approximately 194 weeks following the first dose
Secondary outcome [23] 0 0
Changes in scores of patient-reported outcomes as measured by EuroQol-5 Dimensions-3 Levels (EQ-5D-3L)
Timepoint [23] 0 0
Approximately 194 weeks following the first dose

Eligibility
Key inclusion criteria
Key

1. 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).
2. Disease-specific cohorts:

Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment.
* FL grade 1-3a cohort: Patients with FL grade 1-3a 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: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor.
* 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.
3. Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
5. Adequate bone marrow, hepatic, and renal function as defined in the protocol

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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).
2. 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.
3. History of allogeneic stem cell transplantation
4. 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
5. History of neurodegenerative condition or CNS movement disorder. Patients with a history of seizure within 12 months prior to study enrollment are excluded
6. 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.
7. 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
8. Known hypersensitivity to both allopurinol and rasburicase
9. Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy

Note: Other protocol-defined Inclusion/Exclusion criteria apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/11/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/12/2029
Actual
Sample size
Target
576
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Border Medical Oncology, Albury Wodonga Regional Cancer Centre - East Albury
Recruitment hospital [2] 0 0
Epworth Hospital - East Melbourne
Recruitment hospital [3] 0 0
Penninsula & South Eastern Haemotology and Oncology Group - Frankston
Recruitment hospital [4] 0 0
Andrew Love Cancer Center - Geelong
Recruitment hospital [5] 0 0
Olivia Newton John Cancer Centre - Heidelberg
Recruitment hospital [6] 0 0
The Tweed Hospital - Murdoch
Recruitment hospital [7] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [8] 0 0
Andrew Love Cancer Center - Tweed Heads
Recruitment postcode(s) [1] 0 0
NSW 2640 - East Albury
Recruitment postcode(s) [2] 0 0
VIC 3002 - East Melbourne
Recruitment postcode(s) [3] 0 0
VIC 3199 - Frankston
Recruitment postcode(s) [4] 0 0
VIC 3220 - Geelong
Recruitment postcode(s) [5] 0 0
VIC 3084 - Heidelberg
Recruitment postcode(s) [6] 0 0
NSW 2485 - Murdoch
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment postcode(s) [8] 0 0
VIC3220 - Tweed Heads
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Illinois
Country [2] 0 0
United States of America
State/province [2] 0 0
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Kentucky
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Nova Scotia
Country [16] 0 0
China
State/province [16] 0 0
Beijing
Country [17] 0 0
China
State/province [17] 0 0
Henan
Country [18] 0 0
China
State/province [18] 0 0
Jiangsu
Country [19] 0 0
China
State/province [19] 0 0
Jilin
Country [20] 0 0
China
State/province [20] 0 0
Sichuan
Country [21] 0 0
China
State/province [21] 0 0
Wuhan Hubei Province
Country [22] 0 0
China
State/province [22] 0 0
Zhejiang
Country [23] 0 0
China
State/province [23] 0 0
Canton
Country [24] 0 0
China
State/province [24] 0 0
Chongqing
Country [25] 0 0
China
State/province [25] 0 0
Heilongjiang
Country [26] 0 0
China
State/province [26] 0 0
Shanghai
Country [27] 0 0
China
State/province [27] 0 0
Tianjin
Country [28] 0 0
China
State/province [28] 0 0
Wuhan
Country [29] 0 0
China
State/province [29] 0 0
Xi'an
Country [30] 0 0
France
State/province [30] 0 0
Caen
Country [31] 0 0
France
State/province [31] 0 0
Créteil
Country [32] 0 0
France
State/province [32] 0 0
Lille
Country [33] 0 0
France
State/province [33] 0 0
Nantes
Country [34] 0 0
France
State/province [34] 0 0
Paris
Country [35] 0 0
France
State/province [35] 0 0
Pessac
Country [36] 0 0
France
State/province [36] 0 0
Pierre Bénite
Country [37] 0 0
France
State/province [37] 0 0
Poitiers
Country [38] 0 0
Germany
State/province [38] 0 0
Chemnitz
Country [39] 0 0
Germany
State/province [39] 0 0
Halle
Country [40] 0 0
Germany
State/province [40] 0 0
Mutlangen
Country [41] 0 0
Germany
State/province [41] 0 0
Villingen-Schwenningen
Country [42] 0 0
Germany
State/province [42] 0 0
Wurzburg
Country [43] 0 0
Italy
State/province [43] 0 0
Bologna
Country [44] 0 0
Italy
State/province [44] 0 0
Firenze
Country [45] 0 0
Italy
State/province [45] 0 0
Livorno
Country [46] 0 0
Italy
State/province [46] 0 0
Milano
Country [47] 0 0
Italy
State/province [47] 0 0
Novara
Country [48] 0 0
Italy
State/province [48] 0 0
Perugia
Country [49] 0 0
Italy
State/province [49] 0 0
Ravenna
Country [50] 0 0
Italy
State/province [50] 0 0
Reggio Emilia
Country [51] 0 0
Italy
State/province [51] 0 0
San Giovanni Rotondo
Country [52] 0 0
Italy
State/province [52] 0 0
Terni
Country [53] 0 0
Italy
State/province [53] 0 0
Varese
Country [54] 0 0
Italy
State/province [54] 0 0
Venice
Country [55] 0 0
Japan
State/province [55] 0 0
Aiti
Country [56] 0 0
Japan
State/province [56] 0 0
Chiba-ken
Country [57] 0 0
Japan
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Ehime
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Japan
State/province [58] 0 0
Hukuoka
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Japan
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Hyogo
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Japan
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Kyoto
Country [61] 0 0
Japan
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Chiba
Country [62] 0 0
Japan
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Chuo ku
Country [63] 0 0
Japan
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Isehara-Shi
Country [64] 0 0
Japan
State/province [64] 0 0
Nagasaki
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Japan
State/province [65] 0 0
Osaka City
Country [66] 0 0
Japan
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Saitama
Country [67] 0 0
Japan
State/province [67] 0 0
Yamagata City
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Busan
Country [69] 0 0
Korea, Republic of
State/province [69] 0 0
Daegu-si
Country [70] 0 0
Korea, Republic of
State/province [70] 0 0
Goyang-si
Country [71] 0 0
Korea, Republic of
State/province [71] 0 0
Seoul
Country [72] 0 0
Korea, Republic of
State/province [72] 0 0
Ulsan
Country [73] 0 0
Poland
State/province [73] 0 0
Gdansk
Country [74] 0 0
Poland
State/province [74] 0 0
Gdynia
Country [75] 0 0
Poland
State/province [75] 0 0
Krakow
Country [76] 0 0
Poland
State/province [76] 0 0
Lodz
Country [77] 0 0
Poland
State/province [77] 0 0
Warszawa
Country [78] 0 0
Poland
State/province [78] 0 0
Wroclaw
Country [79] 0 0
Singapore
State/province [79] 0 0
Singapore
Country [80] 0 0
Spain
State/province [80] 0 0
Barcelona
Country [81] 0 0
Spain
State/province [81] 0 0
Donostia
Country [82] 0 0
Spain
State/province [82] 0 0
L'Hospitalet de llobregat
Country [83] 0 0
Spain
State/province [83] 0 0
Madrid
Country [84] 0 0
Spain
State/province [84] 0 0
Marbella
Country [85] 0 0
Spain
State/province [85] 0 0
Palma de Mallorca
Country [86] 0 0
Spain
State/province [86] 0 0
Palma
Country [87] 0 0
Spain
State/province [87] 0 0
Salamanca
Country [88] 0 0
Spain
State/province [88] 0 0
Valencia
Country [89] 0 0
Taiwan
State/province [89] 0 0
Kaohsiung
Country [90] 0 0
Taiwan
State/province [90] 0 0
New Taipei City
Country [91] 0 0
Taiwan
State/province [91] 0 0
Taichung City
Country [92] 0 0
Taiwan
State/province [92] 0 0
Tainan City
Country [93] 0 0
Taiwan
State/province [93] 0 0
Tainan
Country [94] 0 0
Taiwan
State/province [94] 0 0
Taipei City
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taoyuan
Country [96] 0 0
United Kingdom
State/province [96] 0 0
Cardiff
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Edinburgh
Country [98] 0 0
United Kingdom
State/province [98] 0 0
London
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Plymouth
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Sutton
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Regeneron Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trial Management
Address 0 0
Regeneron Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials Administrator
Address 0 0
Country 0 0
Phone 0 0
844-734-6643
Fax 0 0
Email 0 0
clinicaltrials@regeneron.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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
When will data be available (start and end dates)?
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.
Available to whom?
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).
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/


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/NCT03888105