Brentuximab Vedotin in Refractory/Relapsed Hodgkin Lymphoma Treated by ICE

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

53

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

October 31, 2018

Study Completion Date

July 12, 2021

Conditions
Hodgkin Disease
Interventions
DRUG

Brentuximab Vedotin

"Phase I:~Cohort K: BV on Day 1: 1.2 mg/kg (cycle 1-3) and 1.8 mg/kg (cycle 4) Cohort K+1: BV on Day 1: 1.8 mg/kg (cycle 1-3) and 1.8 mg/kg (cycle 4) Cohort K-1: BV on Day 1: 0.8 mg/kg (cycle 1-3) and 1.8 mg/kg (cycle 4)~Phase II:~BV on Day 1: at the Maximal Tolerated Dose (MTD) defined at Phase I"

DRUG

Etoposide

100 mg/m² Days 1-2-3 of Cycles 1-2-3

DRUG

Carboplatine

max 800mg Day 2 of Cycles 1-2-3

DRUG

Ifosfamide

5 g/m² Day 2 of Cycles 1-2-3

Trial Locations (19)

1200

Clinique Universitaire Saint-Luc, Brussels

5530

CHU Dinant Godinne, Yvoir

14033

Institut d'Hématologie de Basse Normandie - CHU Côte de Nacre, Caen

21000

CHU de Dijon - Hôpital le Bocage, Dijon

31100

IUCT Toulouse, Toulouse

34295

CHU Saint Eloi, Montpellier

35033

CHU De Rennes, Rennes

44093

CHU De Nantes, Nantes

54511

CHU De Nancy - Hôpital Brabois, Vandœuvre-lès-Nancy

59037

CHRU Lille - Hôpital Claude Huriez, Lille

67098

CHU De Strasbourg, Strasbourg

69373

Centre Léon Bérard, Lyon

69495

CHU Lyon Sud, Pierre-Bénite

75015

Hôpital Necker, Paris

75475

APHP - Hôpital Saint Louis, Paris

76000

Centre Henri Becquerel, Rouen

86021

CHU de Poitiers - Hôpital de La Milétrie, Poitiers

94010

APHP-Hôpital Henri Mondor, Créteil

94085

Institut Gustave Roussy, Villejuif

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

The Lymphoma Academic Research Organisation

OTHER

NCT02686346 - Brentuximab Vedotin in Refractory/Relapsed Hodgkin Lymphoma Treated by ICE | Biotech Hunter | Biotech Hunter