Extension Trial of Ublituximab and TGR-1202 in Combinatio... | NCT03207256 | Trialant

Extension Trial of Ublituximab and TGR-1202 in Combinatio... | NCT03207256 | Trialant

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TGR-1202	Experimental	Oral TGR-1202 Daily	Drug: TGR-1202
TGR-1202 + Ublituximab	Experimental	Oral TGR-1202 in combination with Ublituximab intravenous administration	Drug: TGR-1202 + Ublituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities	Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)	Evaluated at each planned visit through study completion, an average of 2 years

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment	Date of progression reported for each patient	Evaluated at each planned visit through study completion, an average of 2 years

Contacts/Locations Module

Ancestor Terms

ID	Term
D015448	Leukemia, B-Cell
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D008223	Lymphoma