A Study to Evaluate Adverse Events of Subcutaneous (SC) Epcoritamab Administered in the Outpatient Setting in Adult Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Classic Follicular Lymphoma
Status and phase
Conditions
Treatments
Details and patient eligibility
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
Sex
Ages
Volunteers
Inclusion criteria
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Diagnosis of Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) or R/R Classic Follicular Lymphoma (cFL), with documented CD20+ mature B-cell neoplasm according to World Health Organization (WHO) classification 2016 or WHO classification 2008 based on representative and most recent pathology report:
- Can include participants with "double-hit" or "triple-hit" DLBCL (technically classified in WHO 2016 as HGBCL, with MYC and BCL2 and/or BCL6 translocations). Note: Other double-/triple-hit lymphomas are not eligible.
- Relapsed or refractory disease and previously treated with at least 1 prior systemic anti-lymphoma therapy for DLBCL and 2 prior systemic antineoplastic therapies for cFL including at least 1 anti-CD20 monoclonal antibody-containing therapy
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Has at least one target lesion defined as:
- ≥ 1 measurable nodal lesion (long axis > 1.5 cm and short axis > 1.0 cm) and/or ≥ 1 measurable extranodal lesion (long axis > 1.0 cm) on CT (or MRI) AND
- FDG PET scan demonstrating positive lesion(s) compatible with CT (or MRI) defined anatomical tumor sites.
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Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2.
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Adequate organ function.
Exclusion criteria
- Central nervous system (CNS) involvement by lymphoma.
- Uncontrolled Human Immunodeficiency Virus (HIV) infection. HIV viral load that is undetectable and controlled with medication for at least 1 year prior to enrollment is allowed. Note: If subject has no history of HIV infection, HIV testing does not need to be conducted at screening unless it is required per local guidelines or institutional standards.
Trial design
Primary purpose
Allocation
Interventional model
Masking
184 participants in 4 patient groups
Trial contacts and locations
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Central trial contact
ABBVIE CALL CENTER
Data sourced from clinicaltrials.gov
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