Prisma Health | Upstate Greenville Memorial Cardiac Research
Status and phase
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About
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Classic Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. The purpose of this study is to assess the safety of epcoritamab in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL) who have received at least 1 prior line of systemic antilymphoma therapy including at least 1 anti-CD20 monoclonal antibody-containing therapy or R/R classic follicular lymphoma (cFL). Adverse events will be assessed.
Epcoritamab is an investigational drug being developed for the treatment of R/R DLBCL and R/R cFL. Study doctors will assess participants in a monotherapy treatment arm of epcoritamab. Participants will receive escalating doses of epcoritamab, until full dose is achieved. Approximately 184 adult participants with R/R DLBCL and R/R cFL will be enrolled in the study in approximately 80 sites in the United States of America.
Participants will receive escalating doses of subcutaneous epcoritamab, until full dose is achieved, in 28-day cycles.
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.
Enrollment
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Volunteers
Inclusion criteria
Life expectancy >3 months on standard of care (SOC) treatment.
Meets the following disease activity criteria:
-- Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL):
R/R Follicular Lymphoma:
Documented CD20+ mature B-cell neoplasm according to the 5th edition of WHO classification of Haematolymphoid Tumours, based on representative pathology report;
--- Classic FL (cFL) (previously FL grade 1, 2, or 3a) without clinical or pathological evidence of transformation;
Relapsed or refractory disease and previously treated with at least 2 prior lines of systemic antineoplastic therapies including at least 1 anti-CD20 monoclonal antibody containing therapy; Note: Relapsed disease is defined as disease that previously responded to therapy but progressed >= 6 months after completion of therapy. Refractory disease is defined as disease that either progressed during therapy, failed to achieve an objective response to prior therapy, or progressed within 6 months after completion of therapy (including maintenance therapy).
Previously treated with an alkylating agent or lenalidomide;
Relapsed or refractory to the last prior line therapy. Previous lymphoma therapy is defined as 1 of the following: At least 2 months of single-agent therapy, at least 2 consecutive cycles of combination therapy, autologous HSCT, immunomodulatory therapy, or radioimmunotherapy.
Has at least one target lesion defined as:
Must have ECOG performance status 0 - 2.
Must have acceptable organ (renal, liver, and hematologic) function within the screening period prior to the first dose of study drug:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
184 participants in 4 patient groups
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ABBVIE CALL CENTER
Data sourced from clinicaltrials.gov
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