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Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Summary
The main objective of this trial is to assess whether treatment adaptation based on a very early FDG-PET/CT results in improved efficacy while minimizing treatment toxicity in advanced stage Hodgkin Lymphoma (HL) patients treated with brentuximab vedotin (BV)-containing regimens.
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2019-08-01
Completion Date
2026-11-16
Last Updated
2025-08-11
Healthy Volunteers
No
Conditions
Interventions
Brentuximab Vedotin
For PET positive (score of 4-5 following Deauville Criteria) patients: Brentuximab vedotin is administered as an IV infusion over a period of 30 minutes at 1.8 mg/kg on day 1, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: Brentuximab vedotin is administered as an IV infusion over a period of 30 minutes at 1.2 mg/kg on day 1 and 15, every 4 weeks (5 cycles)
Adriamycin
For PET positive (score of 4-5 following Deauville Criteria) patients: Adriamycin is administered as an IV infusion over a period of 15 minutes at 40 mg/m² on day 2, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: Adriamycin is administered as an IV infusion over a period of 15 minutes at 25 mg/m² on day 1 and 15, every 4 weeks (5 cycles)
Vinblastine
For PET negative (score of 1-3 following Deauville Criteria) patients: Vinblastine is administered as an IV infusion over a period of 15 minutes at 6mg/m² on day 1 and 15, every 4 weeks (5 cycles)
Dacarbazine
For PET positive (score of 4-5 following Deauville Criteria) patients: Dacarbazine is administered as an IV infusion over a period of 60 minutes at 250 mg/m² on day 3 and 4, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: Dacarbazine is administered as an IV infusion over a period of 60 minutes at 375 mg/m² on day 1 and 15, every 4 weeks (5 cycles)
Etoposide
For PET positive (score of 4-5 following Deauville Criteria) patients: Etoposide is administered as an IV infusion over a period of 60 minutes at 150 mg/m² on day 2,3 and 4, every 3 weeks (6 cycles)
Cyclophosphamide
For PET positive (score of 4-5 following Deauville Criteria) patients: Cyclophosphamide is administered as an IV infusion over a period of 30 minutes at 1250 mg/m² on day 2, every 3 weeks (6 cycles)
Radiation Therapy
Patients with residual lymphoma mass(es) showing metabolic activity of Deauville score 4 or 5 after completion of chemotherapy will be offered consolidation radiotherapy.
Locations (16)
ZNA Stuivenberg
Antwerp, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
U.Z. Leuven - Campus Gasthuisberg
Leuven, Belgium
University Hospitals Copenhagen - Rigshospitalet
Copenhagen, Denmark
Amsterdam UMC - Locatie AMC
Amsterdam, Netherlands
Deventer Ziekenhuis
Deventer, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Medisch Centrum Leeuwarden-Zuid
Leeuwarden, Netherlands
Haaglanden Medisch Centrum (HMC) - Haaglanden MC - locatie Antoniushove
Leidschendam, Netherlands
Radboudumc - Radboud University Medical Center Nijmegen
Nijmegen, Netherlands
Erasmus MC
Rotterdam, Netherlands
Maria Sklodowska Curie National Institute of Oncology - National Research Institute
Warsaw, Poland
Instituto Portugues De Oncologia - Francisco Gentil - Centro De Lisboa
Lisbon, Portugal
National Cancer Institute
Bratislava, Slovakia
Hospital Duran i Reynals (Institut Catala D'Oncologia)
L'Hospitalet de Llobregat, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain