Ublituximab in Combination With TGR-1202 +/- Ibrutinib or Bendamustine in Patients With B-cell Malignancies

Status:	Active, not recruiting
Conditions:	Blood Cancer, Lymphoma, Lymphoma
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	9/15/2018
Start Date:	December 2013
End Date:	July 2019

A Phase I/Ib Study Evaluating the Efficacy and Safety of Ublituximab, a Third-Generation Anti-CD20 Monoclonal Antibody, in Combination With TGR-1202, a Novel PI3k Delta Inhibitor; and Ibrutinib or Bendamustine, in Patients With B-cell Malignancies.

The purpose of this study is to evaluate the safety and effectiveness of Ublituximab in
combination with TGR-1202, with or without ibrutinib or bendamustine, in patients with
advanced hematologic malignancies

Inclusion Criteria:

- Confirmed B-cell non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL)/small
lymphocytic lymphoma (SLL), and other B-cell lymphoproliferative disorders as approved
by the Medical Monitor or Study Chair

- Refractory to or relapsed after at least 1 prior treatment regimen

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

Exclusion Criteria:

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

- Known hepatitis B virus, hepatitis C virus or HIV infection

- Autologous hematologic stem cell transplant within 3 months of study entry or
Allogeneic hematologic stem cell transplant within 12 months

- Primary central nervous system lymphoma or known intracranial involvement

We found this trial at

sites

TG Therapeutics Investigational Trial Site

Huntsville, Alabama 35805

from

Huntsville, AL