drugset / Trial / NCT01039376

Ofatumumab Maintenance Treatment vs No Further Treatment in Relapsed CLL Responding to Induction Therapy

NCT01039376

Phase 3 Terminated 480 enrolled Novartis Pharmaceuticals
RandomizedOpen-labelTreatment

Summary

The purpose of this study was to determine if maintenance therapy with ofatumumab would prolong remission in patients with CLL who have responded to second or third line treatment. This study would also evaluate the safety of ofatumumab maintenance compared to observation (the current standard of care). This study was co-developed with the HOVON and NORDIC CLL group and would be conducted as a collaborative effort with GSK.

Timeline

Start
2010-05-06
Primary completion
2017-02-20
Completion
2018-06-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Ofatumumab Monoclonal antibody 1000 mg Intravenous