Drug-drug Interaction Study of Ofatumumab With Bendamustine in Subjects With Indolent B-cell Non-Hodgkin's Lymphoma
The purpose of this study is to evaluate the potential drug-drug interactions between ofatumumab and bendamustine in subjects with previously untreated or relapsed indolent B-cell non-Hodgkin's lymphoma (NHL).
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label Phase I Drug-drug Interaction Study of Ofatumumab With Bendamustine for the Treatment of Subjects With Indolent B-cell Non-Hodgkin's Lymphoma|
- Pharmacokinetic measures of Cmax and Area Under the Curve [ Time Frame: 4 months ] [ Designated as safety issue: No ]The amount of ofatumumab and bendamustine in the blood will be measured when given individually or together to obtain Cmax and Area Under the Curve. Bendamustine levels will be collected at Cycles 1 and 2: Predose, 0.25, 0.5, 0.75, 1 (end of infusion), 1.25, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, and 24 hours. Ofatumumab will be collected at Cycle 4: Predose, end of infusion, then 1, 2, 24, and 72 hours after end of infusion, then once each on Days 8, 15, and 22.
- Vital signs and adverse events [ Time Frame: 14 months ] [ Designated as safety issue: No ]Changes in vital signs will be measured during the entire study to determine any effect on the subjects health. Also the recording of all adverse events that occur during the study will be collected for analysis.
- Measure the extent of the disease [ Time Frame: 14 months ] [ Designated as safety issue: No ]Dimension measurement assessments by CT scan of disease will be collected at Screen, Cycle 5, 3 month follow up visit, and 6 month follow up visit. Flow cytometry measurements will be collected at Screen and Weeks 1, 2, 5, 13, 21, 41, and 53.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||April 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Arm A
bendamustine and ofatumumab treatment of NHL
treatment for NHLDrug: bendamustine
treatment for NHL
Experimental: Arm B
ofatumumab only treatment of NHL
treatment for NHL
The purpose of this study is to evaluate the potential drug-drug interactions between ofatumumab and bendamustine in subjects with previously untreated or relapsed indolent B-cell non-Hodgkin's lymphoma (NHL). Ofatumumab and bendamustine will be administered alone and in combination in a two-arm, open-label study to evaluate the pharmacokinetic profile, safety, tolerability, and efficacy of ofatumumab and bendamustine.
The primary objective of the study is to evaluate pharmacokinetic parameters of ofatumumab and bendamustine alone and in combination. Secondary objectives are to evaluate safety, tolerability, and efficacy.
|Contact: US GSK Clinical Trials Call Center||877-379-3718||GSKClinicalSupportHD@gsk.com|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|