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Clinical trial

A Multi-Center, Open-Label, Compassionate Use Extension Study of Ublituximab (TG-1101) in Combination With Umbralisib (TGR-1202) for Patients Previously Enrolled in Protocol UTX-TGR-304

ID
Name
UTX-TGR-204
Description
The purpose of this study was to provide the opportunity to the participants who progressed on treatment arm previously in the study UTX-TGR-304 (NCT02612311) to receive ublituximab (TG-1101) treatment in combination with umbralisib (TGR-1202).
Trial arms
Trial start
2016-01-07
Estimated PCD
2022-05-26
Trial end
2022-07-11
Status
Terminated
Phase
Early phase I
Treatment
Ublituximab
Ublituximab IV infusion
Arms:
Parent Study Arm B, Parent Study Arm C, Parent Study Arm D
Other names:
TG-1101
Umbralisib
Umbralisib tablets
Arms:
Parent Study Arm B, Parent Study Arm C, Parent Study Arm D
Other names:
TGR-1202
Size
116
Primary endpoint
Overall Response Rate (ORR) as Per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria
Up to 76 months
Complete Response (CR) Rate Per iwCLL Criteria
Up to 76 months
Progression-Free Survival (PFS) Per iwCLL Criteria
Up to 76 months
Duration of Response (DOR)
Up to 76 months
Eligibility criteria
Inclusion Criteria: * Prior treatment in clinical trial UTX-TGR-304 * Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 Exclusion Criteria: * Participants refractory to ublituximab + TGR-1202 * Transformation of chronic lymphocytic leukemia (CLL) to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's transformation)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 116, 'type': 'ACTUAL'}}
Updated at
2023-06-22

1 organization

2 products

1 indication

Product
Ublituximab
Indication
Chronic Lymphocytic Leukemia
Product
Umbralisib
Organization
TG Therapeutics