Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

August 1, 2019

Primary Completion Date

August 28, 2023

Study Completion Date

November 16, 2026

Conditions
Advanced Hodgkin Lymphoma
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.

Trial Locations (16)

833

National Cancer Institute, Bratislava

1099

Instituto Portugues De Oncologia - Francisco Gentil - Centro De Lisboa, Lisbon

1105

Amsterdam UMC - Locatie AMC, Amsterdam

2060

ZNA Stuivenberg, Antwerp

2100

University Hospitals Copenhagen - Rigshospitalet, Copenhagen

2262

Haaglanden Medisch Centrum (HMC) - Haaglanden MC - locatie Antoniushove, Leidschendam

2650

Universitair Ziekenhuis Antwerpen, Edegem

3000

U.Z. Leuven - Campus Gasthuisberg, Leuven

3015

Erasmus MC, Rotterdam

6525

Radboudumc - Radboud University Medical Center Nijmegen, Nijmegen

7400

Deventer Ziekenhuis, Deventer

8934

Medisch Centrum Leeuwarden-Zuid, Leeuwarden

9713

University Medical Center Groningen, Groningen

31008

Complejo Hospitalario de Navarra, Pamplona

02781

Maria Sklodowska Curie National Institute of Oncology - National Research Institute, Warsaw

08908

Hospital Duran i Reynals (Institut Catala D'Oncologia), L'Hospitalet de Llobregat

All Listed Sponsors
lead

European Organisation for Research and Treatment of Cancer - EORTC

NETWORK