An Open Label, Multicenter Study Investigating the Safety and Efficacy of Ofatumumab Therapy Versus Physicians' Choice in Patients With Bulky Fludarabine-Refractory Chronic Lymphocytic Leukaemia (CLL)
Patients with CLL that is refractory to fludarabine have few treatment options and a poor
prognosis. There is a continued need for new therapies for these CLL patients, as
demonstrated by the limited responses and substantial toxicities with existing therapies.
This is supported by the lack of a consensus around standard of care treatment for CLL
patients with bulky fludarabine-refractory disease. The objective of this study is to
confirm the response rate and disease control in the refractory setting through a controlled
trial comparing ofatumumab with the physicians' choice of therapy in fludarabine-refractory,
bulky lymphadenopathy patients. After 24 weeks of treatment with ofatumumab, patients will
be further randomized to either extended ofatumumab treatment or observation. Patients on
the physicians' choice arm will have the option of receiving ofatumumab if they experience
progressive disease.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Approximately 44 months
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
Sweden: Centrala Etikprövningsnämnden
114242
NCT01313689
April 2011
March 2018
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