|Title||TG Therapeutics UTX-TGR-304|
|Principal Investigator/ Physician||David Clarkson, MD|
|Sponsor||TG Therapeutics, Inc.|
|Contact Email||MCI Clinical Trials|
Protocol Title: "Randomized Study to Assess the Efficacy and Safety of Ublituximab in combination with TGR 1202 compared to Obinutuzumab in Combination with Chlorambucil in patients."
Inclusion Criteria: B-Cell CLL that warrants treatment consistent with accepted IWCLL criteria; adequate organ function; measurable lymphadenopathy (>1 nodal lesion that measures >2.0 cm in longest diameter and 1.0 in the longest perpendicular diameter; ECOG less than 2; ability to swallow and retain oral meds.
Exclusion Criteria: cannot be receiving any type of cancer treatment (chemo, radiation, immunotherapy, biologic hormonal, surgery or tumor embolization). No investigational drug within 21 days of randomization, no autologous hematologic stem cell transplant within 3 mo. Of study entry. (excluded if Prior allogeneic hematologic stem cell transplant) histological transformation from CLL to an aggressive lymphoma; prior exposure to idelalisib, duvelisib, ACP-319 or any drug that inhibits phosphoinositice 3-kinase (P13K); prior treatment with obinutuzumasb or chlorambucil, evidence of ongoing systemic infection.
Clinical Trails.Gov Link: https://clinicaltrials.gov/ct2/show/NCT02612311?term=UTX-TGR-304&rank=2
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