drugset / Trial / NCT02280993

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

NCT02280993

NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2014-05
Primary completion
2018-11
Completion
2020-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Brentuximab Vedotin Monoclonal antibody 1.8 mg/kg
Background Cisplatin Other / unclassified 100 mg/m2
Background Cytarabine Small molecule 2 g
Background Dexamethasone Small molecule 40 mg

Indications