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
1. Number of Participants with Adverse Events (AE) (Time Frame - Up to Approximately 3 Years): 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.
2. Maximum Observed Concentration (Cmax) (Time Frame - Up to Approximately Week 37): Maximum observed concentration.
3. 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): AUC from time 0 to time of last measurable concentration within the dosing interval.
Secondary outcome:
1. Percentage of Participants who Achieve Complete Response (CR) (Time Frame - Up to Approximately 1 Year): 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).
2. Number of Participants with Event-free survival (EFS) (Time Frame - Up to Approximately 3 Years): EFS will be defined as the number of days from screening to the date of disease
progression, treatment failure, or death from any cause.
3. Number of Participants who Achieve Overall Survival (OS) (Time Frame - Up to Approximately 3 Years): OS will be defined as the number of days from screening to the date of death from any
cause.
4. Rate of Initiation of Stem Cell Transplantation or Chimeric Antigen Receptor T-cell (CAR-T) Therapy (Time Frame - Up to Approximately 1 Year): Rate of initiation of stem cell transplantation or CAR-T therapy.
5. Percentage of Participants Achieving Overall Response (OR) (Time Frame - Up to Approximately 1 Year): OR is assessed as the percentage of participants with an overall response.
6. Duration of response (DOR) (Time Frame - Up to Approximately 1 Year): 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.
7. Duration of CR (DOCR) (Time Frame - Up to Approximately 1 Year): 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.
8. Percentage of Participants Achieving Immunogenicity (Time Frame - Up to Approximately Week 37): Immunogenicity is defined the percentage of participants with ADA and neutralizing
anti-drug antibodies (nAb).
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"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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