A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenström Macroglobulinemia, OBI-1

PHASE2UnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 21, 2018

Primary Completion Date

April 30, 2019

Study Completion Date

December 31, 2022

Conditions
Waldenstrom Macroglobulinemia
Interventions
DRUG

Obinutuzumab 25 MG/ML

Study treatment, obinutuzumab is a Type II humanized anti-CD20 monoclonal antibody of the IgG1 subclass derived by humanization of the parental B-Ly1 mouse antibody and produced in the Chinese Hamster Ovary cell line by recombinant DNA technology. The Study Treatment, obinutuzumab is a liquid concentrate for infusion. Obinutuzumab vials are type 1 glass vials with a butyl rubber stopper. Obinutuzumab is provided as a single 1000 mg dose liquid concentrate with a strength of 25 mg/mL. It is supplied in 50 mL glass vials containing 40 mL of the 25 mg/mL liquid concentrate.

Trial Locations (2)

60-569

RECRUITING

Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu; Oddział Hematologii i Transplantacji Szpiku, Poznan

50-367

RECRUITING

Uniwersytecki Szpital kliniczy im. Jana Mikulicza-Radeckiego we Wrocławiu; Klinika Hematologii, Nowotworów Krwi Transplantacji Szpiku, Wroclaw

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Roche Pharma AG

INDUSTRY

collaborator

Bioscience, S.A.

INDUSTRY

lead

Polish Myeloma Consortium

OTHER