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Active (not recruiting) Phase 1 NCT05206357

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

Phase 1 – testing safety in a small group of people
Conditions: Non-hodgkin Lymphoma

Sponsor: Genmab

trial.available_in: БГ
Overview
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.
Who can participate
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 . * Adequate bone marrow, hepatic, and renal function. 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.
Locations 14
Australia (1)
Children's Hospital at Westmead /ID# 240091
Westmead , New South Wales
Belgium (1)
Universitair Ziekenhuis Leuven /ID# 242384
Leuven , Vlaams-Brabant
Canada (1)
Hospital for Sick Children /ID# 240767
Toronto , Ontario
Czech Republic (1)
Fakultní Nemocnice Brno - Jihlavská /ID# 239956
Brno , Brno-mesto
France (1)
CHU Bordeaux - Hopital Pellegrin /ID# 240832
Bordeaux , New Aquitaine
Germany (1)
Universitaetsklinikum Erlangen /ID# 240861
Erlangen , Bavaria
Israel (1)
Schneider Children's Medical Center /ID# 240171
Petah Tikva , Central District
Italy (1)
Azienda Ospedaliero Universitaria Meyer /ID# 240049
Florence , Firenze
Japan (1)
NHO Nagoya Medical Center /ID# 246680
Nagoya , Aichi-ken
South Korea (1)
Seoul National University Hospital /ID# 239894
Seoul , Seoul Teugbyeolsi
Spain (1)
Hospital Sant Joan de Deu /ID# 240719
Esplugues de Llobregat , Barcelona
Taiwan (1)
National Taiwan University Hospital /ID# 242890
Taipei City , Taipei
Turkey (1)
Koc Universitesi Hastanesi Translasyonel Tıp Arastırma Merkezi /ID# 240026
Istanbul
United States (1)
Lucile Packard Children's Hospital /ID# 240854
Palo Alto , California
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
1 Year
Maximum age
25 Years
Healthy volunteers
No
Start date
04.10.2022
Completion date
01.11.2028
Registry ID
NCT05206357
Source
anzctr
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