Trials / Terminated
TerminatedNCT02612311
Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
Phase 3, Randomized Study to Assess the Efficacy and Safety of Ublituximab in Combination With TGR-1202 (Umbralisib) Compared to Obinutuzumab in Combination With Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 603 (actual)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Obinutuzumab | Obinutuzumab: IV infusion |
| BIOLOGICAL | Ublituximab | Ublituximab: IV infusion |
| DRUG | TGR-1202 | TGR-1202: Oral daily dose |
| DRUG | Chlorambucil | Chlorambucil: Oral dose |
Timeline
- Start date
- 2015-11-19
- Primary completion
- 2023-02-22
- Completion
- 2023-02-22
- First posted
- 2015-11-23
- Last updated
- 2024-12-13
- Results posted
- 2024-05-07
Locations
154 sites across 7 countries: United States, Israel, Italy, Poland, Russia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02612311. Inclusion in this directory is not an endorsement.