Description:
This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms previously enrolled in Protocol UTX-TGR-304
This is a multi-center, open-label, study to evaluate the safety and efficacy of ublituximab (TG-1101) in combination with TGR-1202 for patients who have progressed on treatment arms previously enrolled in Protocol UTX-TGR-304
Enrolling by invitation
Phase 2
Drug | Synonyms | Arms |
---|---|---|
ublituximab | TG-1101 | Ublituximab + TGR-1202 |
TGR-1202 | Ublituximab + TGR-1202 |
Name | Type | Description | Interventions |
---|---|---|---|
Ublituximab + TGR-1202 | Experimental | Ublituximab IV treatment + TGR-1202 oral daily dose |
|
Inclusion Criteria: - Prior treatment in clinical trial UTX-TGR-304 - Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: - Patients refractory to ublituximab + TGR-1202 - Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Measure: | Overall Response Rate |
Time Frame: | Every 12 weeks up to 2 years |
Safety Issue: | |
Description: | To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab + TGR-1202 |
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Enrolling by invitation |
Lead Sponsor: | TG Therapeutics, Inc. |
August 23, 2021