Clinical Trials

Title   TG Therapeutics UTX-TGR-204
Principal Investigator/ Physician   David Clarkson, MD
Protocol┬áNo.   UTX-TGR-304
Open Date   03/08/2016
Gender   Both
Cancer Site   CLL
Status   Closed
Sponsor   TG Therapeutics, Inc.
Contact Email   MCI Clinical Trials
Summary  

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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