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

TG Therapeutics

Status and phase: Completed; Phase 1

Conditions: Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia

Treatments: Drug: Ublituximab + TGR-1202 + bendamustine; Drug: Ublituximab + TGR-1202; Drug: Ublituximab + TGR-1202 + ibrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02006485

UTX-TGR-103

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 3 patient groups

Ublituximab + TGR-1202

Experimental group

Description:

Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions TGR-1202 oral daily dose

Treatment:

Drug: Ublituximab + TGR-1202

Ublituximab + TGR-1202 + ibrutinib

Experimental group

Description:

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

Treatment:

Drug: Ublituximab + TGR-1202 + ibrutinib

Ublituximab + TGR-1202 + bendamustine

Experimental group

Description:

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

Treatment:

Drug: Ublituximab + TGR-1202 + bendamustine