Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance

PHASE2CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

November 29, 2016

Primary Completion Date

March 31, 2019

Study Completion Date

December 2, 2024

Conditions
Mantle Cell Lymphoma
Interventions
DRUG

Obinutuzumab

1000 mg D1, D8, D15 in GA-DHAP 1000 mg D-8 in GA-BEAM 1000 mg every 2 months for 3 years then every month if MRD+

DRUG

Dexamethasone

40 mg D1 to D4 in GA-DHAP

DRUG

Aracytine

2g/m² D1 \& D2 in GA-DHAP 400 mg/m² D-6 to -3 in GA-BEAM

DRUG

Cisplatinum

100 mg/m² D1 in GA-DHAP

DRUG

Etoposide

400 mg/m² D-6 to D-3 in GA-BEAM

DRUG

Melphalan

140 mg/m² D-2 in GA-BEAM

DRUG

Carmustine

300 mg/m² D-7 in GA-BEAM

Trial Locations (30)

14033

CHU de Caen, Caen

21034

CHU de Dijon - Hôpital le Bocage, Dijon

31100

I.U.C.T Oncopole, Toulouse

33604

CHU de Haut Leveque, Pessac

34295

CHU Montpellier, Montpellier

35033

CHU Pontchaillou, Rennes

37044

CHRU Bretonneau, Tours

38700

CHU de Grenoble, Grenoble

42271

Institut de Cancérologie de Loire, Saint-Priest-en-Jarez

44093

CHU Nantes, Nantes

49000

CHU d'Angers, Angers

51092

CHU Robert Debré, Reims

59037

CHRU Lille - Hôpital Claude Huriez, Lille

63000

CHU de Clermont Ferrand, Clermont-Ferrand

66046

CH Perpignan, Perpignan

67091

CHU de Strasbourg, Strasbourg

69130

CHU Lyon Sud, Pierre-Bénite

72000

Clinique Victor Hugo, Le Mans

74374

Centre Hospitalier Annecy-Genevois, Pringy

75475

Hôpital Saint Louis, Paris

75743

APHP - Hopital Necker, Paris

76038

Centre Henri Becquerel, Rouen

80480

CHU d'Amiens, Amiens

84902

CH d'Avignon, Avignon

85925

CHD Vendée, La Roche-sur-Yon

86021

CHU de Poitiers, Poitiers

87042

CHU Limoges, Limoges

94010

Hopital Henri Mondor, Créteil

94805

Gustave Roussy Cancer Campus, Villejuif

Unknown

CHU de Brabois, Vandœuvre-lès-Nancy

All Listed Sponsors
lead

The Lymphoma Academic Research Organisation

OTHER

NCT02896582 - Efficacy of Upfront and Maintenance Obinutuzumab in Mantle Cell Lymphoma Treated by DHAP and MRD Driven Maintenance | Biotech Hunter | Biotech Hunter