Study of Brentuximab Vedotin in Patients With R/R PTCL Treated With Gemcitabine

PHASE2CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

April 10, 2018

Primary Completion Date

January 31, 2020

Study Completion Date

October 8, 2022

Conditions
Refractory Peripheral T-Cell LymphomaRelapsed Peripheral T-Cell Lymphoma
Interventions
DRUG

Brentuximab Vedotin - induction

Brentuximab vedotin 1.8 mg/kg at D8 of a 28-day cycle - 4 cycles = 16 weeks for combined chemotherapy

DRUG

Gemcitabine

Gemcitabine 1000 mg/m² at D1 and D15 of a 28-day cycle - 4 cycles = 16 weeks for combined chemotherapy

DRUG

Brentuximab Vedotin - maintenance

"Patients who will obtain partial or complete response and who will not be eligible for transplant will receive maintenance therapy with brentuximab vedotin every 3 weeks for 12 infusions.~Brentuximab vedotin 1.8 mg/kg at D1 of a 21-day cycle - 12 cycles = 36 weeks for maintenance therapy"

PROCEDURE

autologous or allogeneic stem cell transplantation

Patients who will obtain partial or complete response and who will be eligible for transplant will receive autologous or allogeneic stem cell transplantation

Trial Locations (39)

1200

Clinique Universitaire Saint LUC, Brussels

2060

ZNA Stuivenberg, Antwerp

4000

CHU de Liege, Liège

8000

A. Z. Sint-Jan, Bruges

9000

UZ Gent, Ghent

21000

CHU de Dijon - Hôpital le Bocage, Dijon

25030

CHU de Besançon - Hôpital Jean Minjoz, Besançon

31059

CHU de Toulouse, Toulouse

33604

Centre François Magendie - Hôpital du Haut Lévêque, Pessac

34295

CH Saint-Eloi, Montpellier

35033

CHU De Rennes, Rennes

37044

CHRU de Tours, Tours

38043

CHU Grenoble, Grenoble

44093

CHU de Nantes - Hôtel Dieu, Nantes

49033

CHU Angers, Angers

54511

CHU Nancy - Brabois, Nancy

59322

CH de Valenciennes, Valenciennes

63000

CHU d'Estaing, Clermont-Ferrand

64100

CH Côte Basque, Bayonne

68070

CH de Mulhouse Sud Alsace, Mulhouse

69373

Centre Leon Berard, Lyon

69495

Centre Hospitalier Lyon Sud, Pierre-Bénite

72000

CH du Mans, Le Mans

73011

CH Chambéry, Chambéry

74374

Centre Hospitalier Annecy Genevois, Metz-Tessy

75015

APHP - Hôpital Necker, Paris

75475

APHP - Hôpital Saint Louis, Paris

76038

Centre Henri BECQUEREL, Rouen

78157

CH de Versailles - Hopital André Mignot, Le Chesnay

80054

IHBN - CHU Cote de Nacre, Amiens

84000

CH d'Avignon - Hôpital Henri Dufaut, Avignon

86021

CHU de Poitiers - Hôpital de la Milétrie, Poitiers

94010

APHP - Hopital Henri Mondor, Créteil

Unknown

Institut Jules Bordet, Brussels

ULB Hôpital Erasme, Brussels

CHU UCL Namur, Yvoir

CHU d'Amiens, Amiens

CHRU de Lille - Hôpital Claude Huriez, Lille

CHU de Limoges, Limoges

All Listed Sponsors
lead

The Lymphoma Academic Research Organisation

OTHER

NCT03496779 - Study of Brentuximab Vedotin in Patients With R/R PTCL Treated With Gemcitabine | Biotech Hunter | Biotech Hunter