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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Subcutaneous Injection (SC)
Lucile Packard Children's Hospital /ID# 240854
Palo Alto, California, United States
Nicklaus Children's Hospital /ID# 241174
Miami, Florida, United States
New York Medical College /ID# 239208
Valhalla, New York, United States
Levine Children's Hospital /ID# 242765
Charlotte, North Carolina, United States
Cincinnati Childrens Hospital Medical Center /ID# 239823
Cincinnati, Ohio, United States
Number of Participants with Adverse Events (AE)
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.
Time frame: Up to Approximately 3 Years
Maximum Observed Concentration (Cmax)
Maximum observed concentration.
Time frame: Up to Approximately Week 37
Area Under the Concentration Versus Time Curve (AUC) from Time 0 to Time of Last Measurable Concentration within the Dosing Interval (AUCtau)
AUC from time 0 to time of last measurable concentration within the dosing interval.
Time frame: Up to Approximately Week 37
Percentage of Participants who Achieve Complete Response (CR)
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).
Time frame: Up to Approximately 1 Year
Number of Participants with Event-free survival (EFS)
EFS will be defined as the number of days from screening to the date of disease progression, treatment failure, or death from any cause.
Time frame: Up to Approximately 3 Years
Number of Participants who Achieve Overall Survival (OS)
OS will be defined as the number of days from screening to the date of death from any cause.
Time frame: Up to Approximately 3 Years
Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy
Rate of initiation of stem cell transplantation or CAR-T therapy.
Time frame: Up to Approximately 1 Year
Percentage of Participants Achieving Overall Response (OR)
OR is assessed as the percentage of participants with an overall response.
Time frame: Up to Approximately 1 Year
Duration of response (DOR)
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.
Time frame: Up to Approximately 1 Year
Duration of CR (DOCR)
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.
Time frame: Up to Approximately 1 Year
Percentage of Participants Achieving Immunogenicity
Immunogenicity is defined the percentage of participants with ADA and neutralizing anti-drug antibodies (nAb).
Time frame: Up to Approximately Week 37
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Children's Hospital of Philadelphia - Main /ID# 239294
Philadelphia, Pennsylvania, United States
St Jude Children's Research Hospital /ID# 239184
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center /ID# 240892
Dallas, Texas, United States
Children's Hospital at Westmead /ID# 240091
Westmead, New South Wales, Australia
Royal Children's Hospital /ID# 240384
Parkville, Victoria, Australia
...and 31 more locations