NCT02244021

BRENTUXIMAB VEDOTIN as Pre-ASCT Induction Therapy in R/R HL Patients Non Responding to IGEV

A Pilot Phase II Study With BRENTUXIMAB VEDOTIN as Pre-ASCT Induction Therapy in Relapsed/Refractory Hodgkin's Lymphoma Patients Non Responding to IGEV Salvage Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A pilot phase II study with brentuximab vedotin as pre-ASCT induction therapy in relapsed/refractory Hodgkin's lymphoma patients non-responding to IGEV salvage treatment.

Detailed description

Brentuximab vedotin emerged as active single-agent in the treatment of relapsed or refractory HL. Some patients don't reach a complete response after salvage treatment with IGEV (ifosfamide, gemcitabine, vinorelbine) and remain PET positive so the idea is to treat this subset of patients with brentuximab vedotin with the aim of achieving a complete remission before transplant.

Conditions

• Relapsed/Refractory Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	BRENTUXIMAB VEDOTIN	Patients with FDG-PET positive after IGEV will be treated with brentuximab vedotin as followed: 1.8 mg/kg every 3 weeks as a 30-minute outpatient IV infusion for a total of 4 cycles of treatment Growth factors may be used at the discretion of investigators but are not routinely advised. Patients with FDG-PET negative after brentuximab vedotin treatment will be addressed to high dose chemotherapy followed by ASCT.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-07-01
• Completion: 2017-10-01
• First posted: 2014-09-18
• Last updated: 2018-02-09

Locations

7 sites across 1 country: Italy