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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05206357
Registration number
NCT05206357
Ethics application status
Date submitted
21/01/2022
Date registered
25/01/2022
Date last updated
4/06/2024
Titles & IDs
Public title
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
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Scientific title
A Single Arm, Open-Label, Phase 1b Trial of Epcoritamab in Pediatric Patients With Relapsed/Refractory Aggressive Mature B-cell Neoplasms
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Secondary ID [1]
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2021-004555-16
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Secondary ID [2]
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M20-429
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-hodgkin Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Epcoritamab
Experimental: Epcoritamab - Participants will receive subcutaneous (SC) epcoritamab in 28 day cycles.
Treatment: Drugs: Epcoritamab
Subcutaneous Injection (SC)
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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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Number of Participants with Adverse Events (AE)
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Assessment method [1]
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An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
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Timepoint [1]
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Up to Approximately 3 Years
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Primary outcome [2]
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Maximum Observed Concentration (Cmax)
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Assessment method [2]
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Maximum observed concentration.
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Timepoint [2]
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Up to Approximately Week 37
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Primary outcome [3]
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Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)
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Assessment method [3]
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AUC from time 0 to time of last measurable concentration within the dosing interval.
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Timepoint [3]
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Up to Approximately Week 37
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Secondary outcome [1]
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Percentage of Participants who Achieve Complete Response (CR)
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Assessment method [1]
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CR is defined per the International Pediatric Non-Hodgkin Lymphoma Response Criteria as computed tomography (CT) or magnetic resonance imaging (MRI) reveals no residual disease or new lesions; Resected residual mass that is pathologically (morphologically) negative for disease (detection of disease with more sensitive techniques); bone marrow (BM) and cerebrospinal fluid (CSF) morphologically free of disease (detection of disease with more sensitive techniques).
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Timepoint [1]
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Up to Approximately 1 Year
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Secondary outcome [2]
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Number of Participants with Event-free survival (EFS)
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Assessment method [2]
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EFS will be defined as the number of days from screening to the date of disease progression, treatment failure, or death from any cause.
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Timepoint [2]
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Up to Approximately 3 Years
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Secondary outcome [3]
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Number of Participants who Achieve Overall Survival (OS)
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Assessment method [3]
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OS will be defined as the number of days from screening to the date of death from any cause.
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Timepoint [3]
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Up to Approximately 3 Years
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Secondary outcome [4]
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Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy
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Assessment method [4]
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Rate of initiation of stem cell transplantation or CAR-T therapy.
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Timepoint [4]
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Up to Approximately 1 Year
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Secondary outcome [5]
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Percentage of Participants Achieving Overall Response (OR)
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Assessment method [5]
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OR is assessed as the percentage of participants with an overall response.
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Timepoint [5]
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Up to Approximately 1 Year
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Secondary outcome [6]
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Duration of response (DOR)
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Assessment method [6]
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DOR is defined as the time between the date of first response to the date of the first documented tumor progression or death due to any cause, whichever comes first.
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Timepoint [6]
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Up to Approximately 1 Year
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Secondary outcome [7]
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Duration of CR (DOCR)
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Assessment method [7]
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DOCR is defined as the time between the date of first CR to the date of the first documented tumor progression or death due to any cause, whichever comes first.
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Timepoint [7]
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Up to Approximately 1 Year
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Secondary outcome [8]
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Percentage of Participants Achieving Immunogenicity
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Assessment method [8]
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Immunogenicity is defined the percentage of participants with ADA and neutralizing anti-drug antibodies (nAb).
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Timepoint [8]
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Up to Approximately Week 37
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Eligibility
Key inclusion criteria
- Participants >= 1 and < 18 years old at time of primary diagnosis with Burkitt's or
Burkitt-like lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), or other
aggressive mature (CD20+) B-cell lymphomas. Participants up to 25 years of age with
Burkitt's or Burkitt-like lymphoma/leukemia are also eligible.
- Disease pathologically confirmed (tumor tissue) by local testing.
- Relapsed or primary refractory disease meeting any of the following criteria:
- Progressive disease at any time during second-line chemoimmunotherapy (CIT).
- Best response of stable disease (SD) after a minimum of 2 cycles of second-line
CIT.
- Best response of partial response (PR) after a minimum of 3 cycles of second-line
CIT.
- Complete Response (CR) after a minimum of 3 cycles of second-line CIT therapy but
unfit or ineligible for consolidation with cell therapy.
- Not in CR and unable to initiate or tolerate (i.e., must discontinue) second-line
CIT.
- Have received cell therapy (allogeneic or autologous transplant or chimeric
antigen receptor T-cell (CAR-T) therapy) as consolidation but have not obtained
or maintained a CR.
- Recovery from toxic effects of prior chemoimmunotherapy.
- Performance status by Lansky (< 16 years old at evaluation) or Karnofsky (>= 16 years
old at evaluation) score >= 50 or Eastern Cooperative Oncology Group (ECOG) score <= 2
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- Adequate bone marrow, hepatic, and renal function.
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Minimum age
1
Year
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Maximum age
25
Years
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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
- Known central nervous system (CNS) involvement by lymphoma at screening as confirmed
by screening magnetic resonance imaging (MRI)/computed tomography (CT)/positron
emission tomography (PET) brain scans (participants with evidence of CNS disease only
in the cerebrospinal fluid (CSF) will be eligible).
- Other malignancy requiring therapy.
- Currently receiving anti-cancer therapy, including chemotherapy (excluding intrathecal
therapy), radiotherapy, small molecules, monoclonal antibodies, cell therapy, or other
investigational agents.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Single group
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Other design features
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Phase
Phase 1
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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
4/10/2022
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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
27/11/2028
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Actual
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Sample size
Target
15
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Royal Children's Hospital /ID# 240384 - Parkville
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Recruitment hospital [2]
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Perth Children's Hospital /ID# 240382 - Nedlands
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Recruitment hospital [3]
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Children's Hospital at Westmead /ID# 240091 - Westmead
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Recruitment postcode(s) [1]
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3052 - Parkville
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment postcode(s) [3]
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2145 - Westmead
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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United States of America
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New York
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Country [4]
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United States of America
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North Carolina
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Country [5]
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United States of America
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Ohio
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United States of America
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State/province [6]
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Pennsylvania
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Country [7]
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United States of America
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State/province [7]
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Tennessee
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United States of America
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Texas
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Belgium
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Vlaams-Brabant
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Canada
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Ontario
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Country [11]
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Canada
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State/province [11]
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Quebec
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Country [12]
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Czechia
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Brno
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Czechia
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Prague
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France
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State/province [14]
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Gironde
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Country [15]
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France
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State/province [15]
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Pays-de-la-Loire
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Country [16]
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France
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State/province [16]
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Val-de-Marne
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France
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Lyon
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Germany
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State/province [18]
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Bayern
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Germany
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Nordrhein-Westfalen
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Germany
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Marburg
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Israel
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H_efa
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Israel
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HaMerkaz
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Israel
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State/province [23]
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Tel-Aviv
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Italy
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State/province [24]
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Firenze
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Italy
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Roma
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Japan
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State/province [26]
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Aichi
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Japan
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Kyoto
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Seoul
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Spain
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Barcelona
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Spain
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Madrid
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Taiwan
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Taipei City
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Turkey
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State/province [34]
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Istanbul
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genmab
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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AbbVie
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
The most common types of mature B-cell lymphomas (MBLs) in children are Burkitt lymphoma (BL)
and diffuse large B-cell lymphoma (DLBCL). Initial treatment cures 90% - 95% of children with
these malignancies, leaving a very small population of relapsed/refractory disease with a
poor prognosis. The purpose of this study is to assess the safety and tolerability of
epcoritamab in pediatric participants with relapsed/refractory aggressive mature B-cell
neoplasms and young adult participants with Burkitt's or Burkitt-like lymphoma/leukemia.
Adverse events and change in disease activity will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of
relapsed/refractory aggressive mature B-cell neoplasms. Participants will receive
subcutaneous (SC) of epcoritamab. Approximately 15 pediatric participants with a diagnosis of
relapsed/refractory aggressive mature B-cell neoplasms and and young adult participants, ages
of 18-25, with a diagnosis of Burkitt's or Burkitt-like lymphoma/leukemia will be enrolled at
50 sites globally.
Participants will receive subcutaneous epcoritamab in 28-day cycles. Participants will be
followed for a minimum of 3 years after enrollment.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at an approved
institution (hospital or clinic). The effect of the treatment will be frequently checked by
medical assessments, blood tests, questionnaires and side effects.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05206357
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05206357
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