Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

July 9, 2020

Study Completion Date

July 9, 2020

Conditions
Hodgkin Lymphoma
Interventions
DRUG

brentuximab vedotin

is 1.8 mg/kg administrated by IV infusion

DRUG

Cyclophosphamide

1250 mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks

DRUG

Adriamycin

35mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks

DRUG

Oncovin

1.4 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks

DRUG

Bleomycin

10 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks

DRUG

Etoposide

200 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D3 of 2 BEACOPP cycles, every 3 weeks

DRUG

Procarbazine

100 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks

DRUG

Prednisone

40 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks

DRUG

G-CSF

5 µg/kg/j, SC, D9 until GB 1.0x109/L

RADIATION

30 Grays

30 Gy radiation of sites initially diagnoses + 6Gy for residual sites, 3 to 4 weeks after D1 of BEACOPP cycle 2.

Trial Locations (30)

13273

Institut Paoli Calmette, Marseille

13385

Hôpital de la Conception, Marseille

14076

Centre François Baclesse, Caen

21034

CHU de Dijon - Hôpital le Bocage, Dijon

31059

I.U.C.T Oncopole, Toulouse

33300

Polyclinique Bordeaux Nord, Bordeaux

33604

Hôpital Haut Lévêque, Pessac

34295

CHU Montpellier - Saint ELOI, Montpellier

35033

CHU Pontchaillou, Rennes

37044

CHU Bretonneau, Tours

44093

CHU de Nantes, Nantes

51092

CHU Robert Debre, Reims

54511

CHU de Brabois, Vandœuvre-lès-Nancy

59037

CHRU Lille - Hôpital Claude Huriez, Lille

66046

CH Perpignan, Perpignan

67098

CHU de Strasbourg, Strasbourg

69008

Centre Léon Bérard, Lyon

69495

CHU Lyon Sud, Pierre-Bénite

72000

Clinique Victor Hugo, Le Mans

73011

CH de Chambéry, Chambéry

75004

Hôpital Cochin, Paris

75475

Hôpital Saint Louis, Paris

75651

Hôpital de la Pitié Salpétrière, Paris

76000

Centre Henri Becquerel, Rouen

78157

Hôpital André Mignot, Le Chesnay

87042

CHU de Limoges, Limoges

91108

CH Sud Francilien, Corbeil-Essonnes

94010

Hôpital Henri Mondor, Créteil

94805

Gustave Roussy Cancer Campus, Villejuif

95100

CH Victor Dupouy, Argenteuil

All Listed Sponsors
lead

The Lymphoma Academic Research Organisation

OTHER

NCT02298283 - Brentuximab Vedotin as Consolidation Treatment in Patients With Stage I/II HL and PET Positivity After 2 Cycles of ABVD | Biotech Hunter | Biotech Hunter