C25006 Ph4 of Brentuximab Vedotin in Patients with Large Cell Lymphoma
Research type
Research Study
Full title
A Phase 4, Open-label, Single-Arm Study of Brentuximab Vedotin in Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma
IRAS ID
124893
Contact name
John Radford
Contact email
Sponsor organisation
Takeda Development Center Americas Inc
Eudract number
2012-004128-39
Research summary
Summary of Results
A Phase 4 open-label study was conducted in 10 countries from January 2014 to August 2024. The study investigated brentuximab vedotin (BV) as a treatment for a rare type of cancer affecting the lymphatic system. Brentuximab vedotin targets CD30 proteins on cancer cells and is known to induce cell death in r/r sALCL (anaplastic large cell lymphoma) participants. The study aimed to check how well BV worked against tumors in participants who had previously received chemotherapy. Disease status (PFS and response) was assessed every 3 months from EOT until the sooner of disease progression, death, or study closure. Overall Survival (OS) was assessed every 3 months from EOT for 18 months, then every 6 months thereafter until the sooner of death or study closure. The study was closed when 50% of patients had an OS event. Overall, brentuximab vedotin showed a meaningful benefit against cancer in these participants.
REC name
HSC REC A
REC reference
13/NI/0072
Date of REC Opinion
8 Jul 2013
REC opinion
Further Information Favourable Opinion