Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia (UNITY-CLL)

TG Therapeutics

Status and phase: Terminated; Phase 3

Conditions: Chronic Lymphocytic Leukemia

Treatments: Drug: TGR-1202; Biological: Obinutuzumab; Biological: Ublituximab; Drug: Chlorambucil

Study type: Interventional

Funder types: Industry

Identifiers

NCT02612311

UTX-TGR-304

2015-005758-36 (EudraCT Number)

Details and patient eligibility

About

This study evaluates the combination of ublituximab, a novel monoclonal antibody, and TGR-1202, a novel PI3K delta inhibitor compared to obinutuzumab and chlorambucil, and compared to ublituximab or TGR-1202 alone in Chronic Lymphocytic Leukemia (CLL) participants.

Enrollment: 603 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment naïve or previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
• Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion criteria

• Any major surgery, chemotherapy or immunotherapy within the last 21 days
• Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
• Autologous hematologic stem cell transplant within 3 months of study entry. Prior Allogeneic hematologic stem cell transplant is excluded
• Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
• Prior therapy with obinutuzumab and/or chlorambucil or a PI3K delta inhibitor

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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603 participants in 4 patient groups

Arm A: Ublituximab + Umbralisib

Experimental group

Description:

Participants 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 cycles 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 87 months.

Treatment:

Biological: Ublituximab

Drug: TGR-1202

Arm B: Obinutuzumab + Chlorambucil

Active Comparator group

Description:

Participants received Obinutuzumab 100 mg, IV on Day 1, 900 mg on Day 2, followed by 1000 mg on Days 8 and 15 of cycle 1 (cycle length = 28 days), Day 1 of Cycle 2-6 along with Chlorambucil 0.5 milligram per kilogram (mg/kg) tablet orally on Days 1 and 15 once daily during each cycle until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.

Treatment:

Drug: Chlorambucil

Biological: Obinutuzumab

Arm C: Ublituximab

Experimental group

Description:

Participants 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 cycles thereafter, until disease progression, lack of tolerability, or until the treatment is commercially available or up to 87 months.

Treatment:

Biological: Ublituximab

Arm D: Umbralisib

Experimental group

Description:

Participants received umbralisib, 800 mg tablets, orally, once daily during each cycle (cycle length= 28 days) until removal from study or up to 87 months.

Treatment:

Drug: TGR-1202