An Open-Label Study to Evaluate the Safety and Efficacy of Ublituximab in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304
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ClinicalTrials.gov Identifier: NCT02656303 |
Recruitment Status :
Active, not recruiting
First Posted : January 14, 2016
Last Update Posted : June 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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Chronic Lymphocytic Leukemia | Biological: ublituximab Drug: TGR-1202 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 300 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Open-Label, Study to Evaluate the Safety and Efficacy of Ublituximab (TG-1101) in Combination With TGR-1202 for Patients Previously Enrolled in Protocol UTX-TGR-304 |
Actual Study Start Date : | January 7, 2016 |
Estimated Primary Completion Date : | January 1, 2025 |
Estimated Study Completion Date : | March 1, 2025 |

Arm | Intervention/treatment |
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Experimental: Ublituximab + TGR-1202
Ublituximab IV treatment + TGR-1202 oral daily dose
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Biological: ublituximab
ublituximab IV infusion
Other Name: TG-1101 Drug: TGR-1202 TGR-1202 oral daily dose |
- Overall Response Rate [ Time Frame: Every 12 weeks up to 2 years ]To assess the overall response rate (ORR) in patients with Chronic Lymphocytic Leukemia treated with ublituximab + TGR-1202

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656303

Responsible Party: | TG Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT02656303 |
Other Study ID Numbers: |
UTX-TGR-204 |
First Posted: | January 14, 2016 Key Record Dates |
Last Update Posted: | June 21, 2022 |
Last Verified: | June 2022 |
Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia Neoplasms by Histologic Type Neoplasms |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell |