EPKINLY Subcutaneous Injection General use-results surveillance (All case): OBSC3013-39D-E

EPKINLY Subcutaneous Injection General use-results surveillance (All case) of relapsed or refractory large B-cell lymphoma and relapsed or refractory follicular lymphoma: OBSC3013-39D-E

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031230525

Enrollment

250

Registered

2023-12-21

Start date

2023-12-21

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory large B-cell lymphoma and relapsed or refractory follicular lymphoma

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients treated with EPKINLY

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

Measure	Time frame
The incidence of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections, cytopenia, tumor lysis syndrome, and progressive multifocal leukoencephalopathy in post-marketing clinical use.	—

Secondary

Measure	Time frame
1: The timing of CRS onset. 2: The rate of CRS preventive measures. 3: The compliance with CRS and ICANS management guidance. 4: The incidence of all adverse events and adverse drug reactions that occurred in clinical use. Overall response rate as determined by Lugano Response Criteria for Malignant Lymphoma (2014)	—

Contacts

Public ContactDrug safety and pharmacovigilance Genmab K.K.

Genmab K.K.

pvpmstoiawase@genmab.com+81-3-4494-8610

Outcome results