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

Phase 1

Completed

• Conditions: Chronic Lymphocytic Leukemia; Non-Hodgkin's Lymphoma
• Interventions: Drug: Ublituximab + TGR-1202; Drug: Ublituximab + TGR-1202 + ibrutinib; Drug: Ublituximab + TGR-1202 + bendamustine

• Registration Number: NCT02006485
• Lead Sponsor: TG Therapeutics, Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Study Start: 2013-12-13
• Primary Completion: 2019-10
• Study Completion: 2019-10
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved by the Medical Monitor or Study Chair
• Refractory to or relapsed after at least 1 prior treatment regimen
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria

• Any major surgery, chemotherapy or immunotherapy within the last 21 days
• Known hepatitis B virus, hepatitis C virus or HIV infection
• Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months
• Primary central nervous system lymphoma or known intracranial involvement

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ublituximab + TGR-1202	Ublituximab + TGR-1202	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose
Ublituximab + TGR-1202 + ibrutinib	Ublituximab + TGR-1202 + ibrutinib	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose ibrutinib oral daily dose
Ublituximab + TGR-1202 + bendamustine	Ublituximab + TGR-1202 + bendamustine	Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose Bendamustine at a fixed IV infusion on Days 1 \& 2

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose acceptable for participants	28 days (1 cycle of therapy)	To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 1 year	To assess the overall response rate (ORR) in patients with hematologic malignancies treated with Ublituximab in combination with TGR-1202

Trial Locations

Locations (2)

TG Therapeutics Investigational Trial Site; 🇺🇸 Omaha, Nebraska, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States