|Title||TG Therapeutics UTX-TGR-204|
|Principal Investigator/ Physician||David Clarkson, MD|
|Sponsor||TG Therapeutics, Inc.|
|Contact Email||MCI Clinical Trials|
Protocol Title: "Phase 3 Randomized Study to Assess the Efficacy and Safety of Ublituximab in combination with TGR-1202 compared to Obinutuzumab in Combination with Chlorambucil in Patients with CLL."
Inclusion Criteria: Prior treatment in clinical trial UTX-TGR-304, confirmed progression, adequate organ function, ECOG<2, ability to swallow and retain oral meds.
Exclusion Criteria: Prior treatment with obnutuzumab +chlorambucil (Arm B patients) or Ublituximab (Arm C patients) within 7 days of Cycle 1 Day 1, known histological transformation from CLL to an aggressive lymphoma (i.e. Richter’s ) Evidence of ongoing systemic bacterial fungal, or viral infection except localized fungal infections of skin or nails.
Clinical Trails.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02656303?term=UTX-TGR-204&rank=1
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