Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

102

Participants

Timeline

Start Date

June 1, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2031

Conditions
Waldenstrom Macroglobulinemia
Interventions
DRUG

zanubrutinib + BGB-11417

"The investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and BGB-11417.Treatment will be administered for a total of twenty 28 day cycles:~Cycle 1 with zanubrutinib only~Cycle 2 with zanubrutinib plus BGB-11417 ramp-up cycle 2, day 1 : 10mg cycle 2, day 2 : 20 mg cycle 2, day 3 : 40mg cycle 2, day 4-7 : 80md daily cycle 2, day 8 and beyond : 160 mg daily~Cycles 3-20 with zanubrutinib plus BGB-11417 full dose"

Trial Locations (37)

13000

MARSEILLE - Institut Paoli-Calmettes, Marseille

14033

CAEN - CHU Caen - IHBN, Caen

21000

DIJON - Hôpital François Mitterrand, Dijon

25000

BESANCON - Hôpital Jean Minjoz, Besançon

31059

Toulouse - IUCT Oncopole - Service d'Hématologie, Toulouse

33076

Bordeaux-Institut Bergonié, Bordeaux

33604

Bordeaux Pessac, Pessac

34295

MONTPELLIER - Hôpital Saint-Eloi - Hématologie Clinique, Montpellier

35033

RENNES - CHU Pontchaillou - Hématologie Clinique, Rennes

37000

TOURS - Hôpital Bretonneau, Tours

38043

Grenoble - CHUGA - Hématologie Clinique, Grenoble

44093

NANTES - Hôpital Hôtel Dieu - Hématologie Clinique, Nantes

44100

ORLEANS - CHR - Hématologie, Orléans

49933

Angers Chu, Angers

51092

Reims Chu, Reims

54500

NANCY - CHU Brabois, Vandœuvre-lès-Nancy

59000

LILLE GHICL - Hôpital Saint Vincent de Paul, Lille

59037

LILLE CHU - Hôpital Claude Huriez, Lille

63000

Clermont-Ferrand - Chu Estaing, Clermont-Ferrand

64109

BAYONNE - CH de la Côte Basque - Hématologie, Bayonne

66000

PERPIGNAN - CH St Jean - Hématologie Clinique, Perpignan

67033

Strasbourg - Icans, Strasbourg

68100

Mulhouse - Ghrmsa, Mulhouse

69008

LYON-Centre Léon Bérard, Lyon

69036

LYON HCL - CH Lyon Sud, Pierre-Bénite

74374

ANNECY - CH Annecy Genevois, Annecy

75651

APHP - Hôpital Pitié Salpêtrière - Hématologie, Paris

76038

ROUEN - Centre Henri Becquerel - Service Hématologie Clinique, Rouen

80054

AMIENS - CH Amiens Picardie Site Sud, Amiens

85925

La Roche Sur Yon - Chd Vendee, La Roche-sur-Yon

86021

POITIERS - Hématologie et Thérapie Cellulaire, Poitiers

94000

CRETEIL - CHU Henri Mondor, Créteil

Unknown

ARGENTEUIL - Centre hospitalier Victor Dupouy, Argenteuil

Le Mans CH, Le Mans

Vannes - Chba, Vannes

VERSAILLES - Hôpital André Mignot, Versailles

Villejuif Igr, Villejuif

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BeiGene

INDUSTRY

lead

French Innovative Leukemia Organisation

OTHER

NCT06547866 - Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia | Biotech Hunter | Biotech Hunter