NCT01594229

A Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Combination With Bendamustine/Rituximab (BR) in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, multicenter study evaluating the safety, pharmacokinetic profile, and preliminary efficacy of ABT-199 in combination with Bendamustine/Rituximab in approximately 60 subjects with relapsed or refractory non-Hodgkin's lymphoma. This study will evaluate the safety and pharmacokinetic profile of ABT-199 in approximately 60 subjects when administered in combination with Bendamustine/Rituximab following a dose escalation scheme, with the objective of defining the dose limiting toxicity and the maximum tolerated dose.

Conditions

• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	ABT-199	ABT-199 is taken orally once daily for 3 days out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-199 will change throughout the study.
DRUG	Rituximab	Rituximab will be given by intravenous infusion for 1 day out of each 28 day cycle.
DRUG	Bendamustine	Bendamustine will be given by intravenous infusion for 2 days out of each 28 day cycle.

Timeline

• Start date: 2012-05-21
• Primary completion: 2020-07-14
• Completion: 2020-07-14
• First posted: 2012-05-09
• Last updated: 2021-08-02

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study