Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients

TG Therapeutics

Status and phase: Completed; Phase 1

Conditions: Hodgkin's Lymphoma

Treatments: Drug: TGR-1202 + brentuximab vedotin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02164006

TGR-BV-107

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with brentuximab vedotin in patients with hodgkin's lymphoma.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of Hodgkin's Lymphoma
• Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT
• 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. Patients who had prior Allogeneic hematologic stem cell transplant are excluded

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

TGR-1202 + brentuximab vedotin

Experimental group

Description:

TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin

Treatment:

Drug: TGR-1202 + brentuximab vedotin