An Open-Label, Single-Arm, Phase I Study to Evaluate the Effect of Ofatumumab on Cardiac Repolarization (QTc Duration) in Patients With Fludarabine-Refractory B-cell Chronic Lymphocytic Leukemia
The purpose of this trial is to assess the impact of ofatumumab on electrocardiographic
parameters with particular focus on cardiac repolarization (QTc interval duration) in
subjects with refractory Chronic Lymphocytic Leukemia (CLL).
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Cardiac Repolarization (Fredericia's QTc)
ECGs are collected in triplicate during the study to assess QTc effect.
25-week ofatumumab treatment period
GSK Clinical Trials
New Zealand: Medsafe
|GSK Investigational Site||Bakersfield, California 93309|