NCT02280993

Phase I/II Feasibility Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (DHAP) in Hodgkin Lymphoma Patients

Phase I/II Feasibility Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (DHAP) in Hodgkin Lymphoma Patients Refractory to First Line Chemotherapy or in First Relapse Who Are Eligible for High Dose Treatment Followed by Autologous Peripheral Blood Stem Cell Transplantation (ASCT)

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Marjolein Spiering · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To combine Brentuximab Vedotin with Dexamethasone, AraC and Cisplatin (DHAP) chemotherapy in patients with Hodgkin lymphoma (HL) refractory to first line chemotherapy or in first relapse is expected to induce a significantly higher (metabolic) complete remission (CR) rate prior to consolidation with BEAM, as judged by FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose)-PET negativity. This will be compared with published data on DHAP salvage only. Increasing the metabolic CR rate prior to consolidation with high dose chemotherapy and autologous stem cell transplantation (ASCT) is expected to improve progression free survival (PFS) and overall survival (OS).

Conditions

• Hodgkin Lymphoma
• Refractory
• Relapse

Interventions

Type	Name	Description
DRUG	DHAP	DHAP
DRUG	Brentuximab Vedotin	Brentuximab Vedotin
OTHER	Autologous Peripheral Blood Stem Cell Transplantation	Autologous Peripheral Blood Stem Cell Transplantation

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-11-01
• Completion: 2020-05-01
• First posted: 2014-11-03
• Last updated: 2018-03-13

Locations

13 sites across 4 countries: Denmark, France, Netherlands, United Kingdom