NCT02006485

Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies

A Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination With TGR-1202, a Novel PI3k Delta Inhibitor; and Ibrutinib or Bendamustine, in Patients With B-cell Malignancies.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: TG Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with advanced hematologic malignancies

Conditions

• Chronic Lymphocytic Leukemia
• Non-Hodgkin's Lymphoma

Interventions

Type	Name	Description
DRUG	Ublituximab + TGR-1202	Ublituximab IV infusion TGR-1202 oral daily dose
DRUG	Ublituximab + TGR-1202 + ibrutinib	Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose
DRUG	Ublituximab + TGR-1202 + bendamustine	Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion

Timeline

• Start date: 2013-12-13
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2013-12-10
• Last updated: 2019-11-05

Locations

6 sites across 1 country: United States