Transplant BRaVE Version 1
Research type
Research Study
Full title
Phase I/II feasibility study combining Brentuximab Vedotin with second line salvage chemotherapy (DHAP) in Hodgkin Lymphoma patients with refractory to first line chemotherapy or in first relapse who are eligible for high dose treatment followed by autologous peripheral blood stem cell transplantation
IRAS ID
154463
Contact name
John Radford
Contact email
Sponsor organisation
University of Amsterdam
Eudract number
2012-003097-45
Duration of Study in the UK
4 years, 4 months, 1 days
Research summary
For the last 30 years standard treatment of Hodgkin lymphoma (HL) patients refractory to first line chemotherapy or in first relapse has been to test for chemosensitivity to second line chemotherapy and folowing achievement of response (partial or complete remission/PR or CR) to treat with high dose chemotherapy followed by autologous peripheral blood stem cell transplantation (Auto-PBSCT). With this strategy approximately 90% of patients prove to be chemosensitive and thus become eligible for high dose treatment and auto-PBSCT. However, approximately 30% of all patients relapses within 3 years after auto-PBSCT and will ultimately die from the disease. As the disease status before high dose chemotherapy and auto-PBSCT appears to be the most important factor predicting outcome, the current trial aims at increasing the (metabolic) CR rate after DHAP by combining DHAP with Brentuximab Vedotin (SGN-35). It is hypothesized that further reduction of the tumour load prior to high dose chemotherapy and auto-PBSCT will decrease the chance of relapse after auto-PBSCT and will enhance the cure rate.
Phase I - Primary objective is to identify the feasibility and RDL (recommended dose level) of BV in combination with DHAP, in a 21-day schedule.
Phase II - Primary objective is to demonstrate the efficacy and safety of BV in combination with DHAP as salvage treatment(establish the fraction of responding patients – metabolic CR – as judged by PET-CT after the third cycle), and to establish the rate of grade 3/4 non-hematological toxicity including neurotoxicity.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0011
Date of REC Opinion
4 Mar 2015
REC opinion
Further Information Favourable Opinion