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ACTIVE NOT RECRUITING
NCT03517137
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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)

DRUG

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)

DRUG

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)

DRUG

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)

DRUG

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)

DRUG

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

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