drugset
drugset / Trial / NCT02336048

A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Comorbidities

NCT02336048 ↗

Phase 1 Terminated 38 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This multicenter, double-blind, randomized, placebo-controlled study will evaluate the safety of a single infusion of tocilizumab versus placebo, administered in addition to standard premedications (antipyretic, antihistamine, and corticosteroid) prior to the first infusion of obinutuzumab administered in combination with oral chlorambucil to participants with previously untreated B-CLL who have comorbidities. All eligible participants will be treated with a total of 6 cycles of obinutuzumab + chlorambucil (cycle length = 28 days).

Timeline

Start
2015-06-26
Primary completion
2018-09-21
Completion
2018-09-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Subject Tocilizumab Monoclonal antibody 20 mg/kg Intravenous
Background Chlorambucil Other / unclassified 0.5 mg/kg Oral
Background Obinutuzumab Monoclonal antibody 1000 mg Intravenous

Indications

B-cell chronic lymphocytic leukemia