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Активно (без набиране) Фаза 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

Фаза 1 – тестване на безопасността при малка група хора
Заболявания: Non-hodgkin Lymphoma

Спонсор: Genmab

Налично на: БГ
Обобщение
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.
Кой може да участва
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.
Места на провеждане 14
Австралия (1)
Children's Hospital at Westmead /ID# 240091
Westmead , New South Wales
Белгия (1)
Universitair Ziekenhuis Leuven /ID# 242384
Leuven , Vlaams-Brabant
Канада (1)
Hospital for Sick Children /ID# 240767
Toronto , Ontario
Чехия (1)
Fakultní Nemocnice Brno - Jihlavská /ID# 239956
Brno , Brno-mesto
Франция (1)
CHU Bordeaux - Hopital Pellegrin /ID# 240832
Bordeaux , New Aquitaine
Германия (1)
Universitaetsklinikum Erlangen /ID# 240861
Erlangen , Bavaria
Израел (1)
Schneider Children's Medical Center /ID# 240171
Petah Tikva , Central District
Италия (1)
Azienda Ospedaliero Universitaria Meyer /ID# 240049
Florence , Firenze
Япония (1)
NHO Nagoya Medical Center /ID# 246680
Nagoya , Aichi-ken
Южна Корея (1)
Seoul National University Hospital /ID# 239894
Seoul , Seoul Teugbyeolsi
Испания (1)
Hospital Sant Joan de Deu /ID# 240719
Esplugues de Llobregat , Barcelona
Taiwan (1)
National Taiwan University Hospital /ID# 242890
Taipei City , Taipei
Турция (1)
Koc Universitesi Hastanesi Translasyonel Tıp Arastırma Merkezi /ID# 240026
Istanbul
САЩ (1)
Lucile Packard Children's Hospital /ID# 240854
Palo Alto , California
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 1
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
1 Year
Максимална възраст
25 Years
Здрави доброволци
Не
Начална дата
04.10.2022
Крайна дата
01.11.2028
Регистрационен номер
NCT05206357
Източник
anzctr
Запитване за медицински туризъм

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