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

NCT03679455 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-11-13

No results posted yet for this study

Summary

This is a multi-center, single-arm, open label, non-randomized, phase II study designed to investigate the efficacy, safety and tolerability of obinutuzumab given as monotherapy in patients with relapsed/refractory Waldenström Macroglobulinemia (R/R MW).

Conditions

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.

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Bioscience, S.A.

    collaborator INDUSTRY

  • Polish Myeloma Consortium

    lead OTHER

Principal Investigators

  • Tomasz Wróbel, MD.PhD · USK Wrocław

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-21
Primary Completion
2019-04-30
Completion
2022-12-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03679455 on ClinicalTrials.gov