Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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.
Eligibility
Primary outcome measure(s)
- Modified Progression-free Survival (mPFS) Rate at 2 Years — 2 years from the date of treatment start
Modified PFS (mPFS) is defined as the time interval between the date of treatment start and the date of the first of: * Progressive disease (PD) * Start of new treatment for Classical Hodgkin Lymphoma (cHL) when not in Complete Response at the end of protocol treatment; in this case, the date of mPFS is the date of the FDG-PET/CT scan at the end of protocol treatment. Switching therapy prior to end of protocol treatment for reasons other than Progressive Disease is not considered an event for mPFS. "End of protocol treatment" refers to completion of the planned protocol treatment with no more than 1 missed cycle, including radiotherapy on PET positive lesions if administered * Death due to any cause
Trial sites (16)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
On this site
📄 Adcetris (brentuximab vedotin) drug profile →More European Organisation for Research and Treatment of Cancer - EORTC trials in Belgium
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03517137 on ClinicalTrials.gov ↗ ← All trials in Belgium