Ublituximab + TGR-1202 Compared to Obinutuzumab + Chlorambucil in Participants With Untreated and Previously Treated Chronic Lymphocytic Leukemia
Stopped early · Phase 3
Conditions studied: Chronic Lymphocytic Leukemia
In brief
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.
Key facts
- Study ID
- NCT02612311
- Run by
- TG Therapeutics, Inc.
- People needed
- 603
- Starts
- 2015-11-19
- Expected to finish
- 2023-02-22
- Last updated by the study team
- 2024-12-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Treatment naïve or previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
You may not qualify if…
- 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
Where it is running
- TG Therapeutics Investigational Trial Site — Mobile, Alabama, United States
- TG Therapeutics Investigational Trial Site — Chandler, Arizona, United States
- TG Therapeutics Investigational Trial Site — Phoenix, Arizona, United States
- TG Therapeutics Investigational Trial Site — Tucson, Arizona, United States
- TG Therapeutics Investigational Trial Site — Fayetteville, Arkansas, United States
- TG Therapeutics Investigational Trial Site — Concord, California, United States
- TG Therapeutics Investigational Trial Site — Duarte, California, United States
- TG Therapeutics Investigational Trial Site — Greenbrae, California, United States
- TG Therapeutics Investigational Trial Site — Pismo Beach, California, United States
- TG Therapeutics Investigational Trial Site — Pleasanton, California, United States
- TG Therapeutics Investigational Trial Site — San Diego, California, United States
- TG Therapeutics Investigational Trial Site — Santa Barbara, California, United States
- TG Therapeutics Investigational Trial Site — Whittier, California, United States
- TG Therapeutics Investigational Trial Site — Aurora, Colorado, United States
- TG Therapeutics Investigational Trial Site — Denver, Colorado, United States
- TG Therapeutics Investigational Trial Site — Bridgeport, Connecticut, United States
- TG Therapeutics Investigational Trial Site — New Haven, Connecticut, United States
- TG Therapeutics Investigational Trial Site — Stamford, Connecticut, United States
- TG Therapeutics Investigational Trial Site — Newark, Delaware, United States
- TG Therapeutics Investigational Trial Site — Boca Raton, Florida, United States
- TG Therapeutics Investigational Trial Site — Fort Myers, Florida, United States
- TG Therapeutics Investigational Trial Site — Jacksonville, Florida, United States
- TG Therapeutics Investigational Trial Site — Jacksonville, Florida, United States
- TG Therapeutics Investigational Trial Site — Ocala, Florida, United States
- TG Therapeutics Investigational Trial Site — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.