Study to Assess the Efficacy and Safety of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkins Lymphoma



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/6/2019
Start Date:June 2016
End Date:July 2019
Contact:TG Therapeutics Clinical Support Team
Email:clinicalsupport@tgtxinc.com
Phone:212-554-4279

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A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + TGR-1202 With or Without Bendamustine and TGR-1202 Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma

This research study will evaluate the safety and efficacy of a study drug called TGR-1202 in
combination with another study drug called ublituximab with or without bendamustine and
TGR-1202 alone as a possible treatment for Non-Hodgkin's Lymphoma (NHL) that has come back or
that has not responded to standard treatment.


Inclusion Criteria:

- Diagnosis of Non-Hodgkin's Lymphoma including Diffuse Large B-cell Lymphoma,
Follicular, Small Lymphocytic and Marginal Zone Lymphoma

- Relapsed or refractory to prior standard therapy and subjects who are not candidates
for high-dose therapy or autologous stem cell transplant

- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

Exclusion Criteria:

- Any major surgery, chemotherapy or immunotherapy within the last 21 days

- Evidence of hepatitis B virus, hepatitis C virus or known HIV infection

- Autologous hematologic stem cell transplant within 6 months of study entry. Prior
Allogeneic hematologic stem cell transplant is excluded

- Prior therapy with a PI3K delta inhibitor
We found this trial at
106
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Ann Arbor, Michigan 48106
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