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 ...
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Location | Status | Site Contact Details |
---|---|---|
Location Lucile Packard Children's Hospital, Palo Alto, California, 94304 | Status Recruiting | Site Contact Details |
Location Nicklaus Children's Hospital, Miami, Florida, 33155-3009 | Status Recruiting | Site Contact Details |
Location New York Medical College, Valhalla, New York, 10595 | Status Recruiting | Site Contact Details |
Location Levine Children's Hospital, Charlotte, North Carolina, 28203-5812 | Status Recruiting | Site Contact Details |
Location Cincinnati Childrens Hospital Medical Center, Cincinnati, Ohio, 45229 | Status Recruiting | Site Contact Details |
Location Children's Hospital of Philadelphia - Main, Philadelphia, Pennsylvania, 19104-4319 | Status Recruiting | Site Contact Details |
Location St Jude Children's Research Hospital, Memphis, Tennessee, 38105 | Status Recruiting | Site Contact Details |
Location Hospital for Sick Children, Toronto, Ontario, M5G 1X8 | Status Recruiting | Site Contact Details |
Location CHU Sainte-Justine, Montreal, Quebec, H3T 1C5 | Status Recruiting | Site Contact Details |
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.
Number of Participants with Adverse Events (AE)
Time Frame: Up to Approximately 3 Years
Maximum Observed Concentration (Cmax)
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)
Time Frame: Up to Approximately Week 37
Percentage of Participants who Achieve Complete Response (CR)
Time Frame: Up to Approximately 1 Year
Number of Participants with Event-free survival (EFS)
Time Frame: Up to Approximately 3 Years
Number of Participants who Achieve Overall Survival (OS)
Time Frame: Up to Approximately 3 Years
Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy
Time Frame: Up to Approximately 1 Year
Percentage of Participants Achieving Overall Response (OR)
Time Frame: Up to Approximately 1 Year
Duration of response (DOR)
Time Frame: Up to Approximately 1 Year
Duration of CR (DOCR)
Time Frame: Up to Approximately 1 Year
Percentage of Participants Achieving Immunogenicity
Time Frame: Up to Approximately Week 37
Interventions:
Enrollment:
15
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