A Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With Umbralisib for Participants Previously Enrolled in Protocol UTX-TGR-304

TG Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Chronic Lymphocytic Leukemia

Treatments: Biological: Ublituximab; Drug: Umbralisib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02656303

2016-004339-19 (EudraCT Number)

UTX-TGR-204

Details and patient eligibility

About

The purpose of this study was to provide the opportunity to the participants who progressed on treatment arm previously in the study UTX-TGR-304 (NCT02612311) to receive ublituximab (TG-1101) treatment in combination with umbralisib (TGR-1202).

Enrollment: 116 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Prior treatment in clinical trial UTX-TGR-304
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion criteria

• Participants refractory to ublituximab + TGR-1202
• Transformation of chronic lymphocytic leukemia (CLL) to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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116 participants in 3 patient groups

Parent Study Arm B

Experimental group

Description:

Participants from Arm B of the parent trial (UTX-TGR-304) received ublituximab, 150 milligrams (mg), intravenously (IV), on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.

Treatment:

Drug: Umbralisib

Biological: Ublituximab

Parent Study Arm C

Experimental group

Description:

Participants from Arm C of the parent trial (UTX-TGR-304) received ublituximab, 900 mg, IV, on Day 1 of Cycles 1-6 (cycle length=28 days), and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.

Treatment:

Drug: Umbralisib

Biological: Ublituximab

Parent Study Arm D

Experimental group

Description:

Participants from Arm D of the parent trial (UTX-TGR-304) received ublituximab, 150 mg, IV, on Day 1, 750 mg on Day 2, followed by 900 mg on Days 8 and 15 of Cycle 1 (cycle length=28 days), Day 1 of Cycles 2-6, and once every 3 months thereafter, along with umbralisib, 800 mg, orally, once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 78 months.

Treatment:

Drug: Umbralisib

Biological: Ublituximab