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

The purpose of this study is to determine if maintenance therapy with ofatumumab will prolong remission in patients with CLL who have responded to second or third line treatment. This study will 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 will be conducted as a collaborative effort with GSK.


Study Type: Interventional
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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
Enrollment: 480
Study Start Date: May 2010
Estimated Study Completion Date: May 2017
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)

Arms:
- Experimental: ARM A: Ofatumumab
- ARM B: Observation and assessments as per Arm A