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

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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)

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

Trial documents
2

Trial contacts and locations

154

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Data sourced from clinicaltrials.gov

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