Spots Global Cancer Trial Database for Phase I/II Feasibility Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (DHAP) in Hodgkin Lymphoma Patients
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Trial Identification
Brief Title: Phase I/II Feasibility Study Combining Brentuximab Vedotin With Second Line Salvage Chemotherapy (DHAP) in Hodgkin Lymphoma Patients
Official Title: 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)
Study ID: NCT02280993
Study Description
Brief 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).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Rigshospitalet, Copenhagen, , Denmark
Centre Hospitalier Universitaire, Lille, , France
Hospices Civils de Lyon, Lyon, , France
Centre Hospitalier et Universitaire, Nantes, , France
Hôpital Saint Louis, Paris, , France
Institut Gustave Roussy, Paris, , France
Academic Medical Center, Amsterdam, , Netherlands
Free University Medical Center, Amsterdam, , Netherlands
University Medical Center Groningen, Groningen, , Netherlands
Erasmus Medical Center, Rotterdam, , Netherlands
Cambridge University Hospitals NHS Foundation Trust | Addenbrooke's Hospital, Cambridge, , United Kingdom
King's College Hospital NHS Foundation Trust, London, , United Kingdom
Christie Hospital, Manchester, Manchester, , United Kingdom
Contact Details
Name: Anton Hagenbeek, PhD MD
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: PRINCIPAL_INVESTIGATOR
Name: Marie José Kersten, PhD MD
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: PRINCIPAL_INVESTIGATOR
Name: Marjolein Spiering, MSc
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: STUDY_DIRECTOR
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