Spots Global Cancer Trial Database for Drug-drug Interaction Study of Ofatumumab With Bendamustine in Subjects With Indolent B-cell Non-Hodgkin's Lymphoma

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Trial Identification

Brief Title: Drug-drug Interaction Study of Ofatumumab With Bendamustine in Subjects With Indolent B-cell Non-Hodgkin's Lymphoma

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

Study ID: NCT01691807

Conditions

Cancer

Interventions

ofatumumab

bendamustine

Study Description

Brief Summary: 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).

Detailed Description: 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.