NCT01039376

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

A Phase III, Open Label, Randomized, Multicenter Trial of Ofatumumab Maintenance Treatment Versus no Further Treatment in Subjects With Relapsed Chronic Lymphocytic Leukemia (CLL) Who Have Responded to Induction Therapy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The study met its primary objective at the protocol defined interim analysis (data cut-off 19-Jun-2014). The protocol-defined final analysis of the primary endpoint was performed when 280 PFS events were reached (data cut-off 20-Feb-2017).

Conditions

• Leukaemia, Lymphocytic, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	Ofatumumab	Ofatumumab for maintenance therapy as IV infusions every 8 weeks . The first dose was 300 mg followed 1 week later by 1000 mg and 1000 mg every 8 weeks thereafter for up to 2 years.
OTHER	Observation	Observation/Safety Evaluation

Timeline

• Start date: 2010-05-06
• Primary completion: 2017-02-20
• Completion: 2018-06-26
• First posted: 2009-12-25
• Last updated: 2019-07-30
• Results posted: 2015-04-21

Locations

203 sites across 25 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Greece, Hungary, India, Israel, Italy, Netherlands, Norway, Poland, Puerto Rico, Russia, South Korea, Spain, Sweden, Turkey (Türkiye), Ukraine