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

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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
6
sites
1152
mi
from
Duarte, CA
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800
mi
from
Atlanta, GA
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Houston, Texas 77030
Principal Investigator: Nathan Fowler, MD
Phone: 212-554-4484
572
mi
from
Houston, TX
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Huntsville, Alabama 35805
659
mi
from
Huntsville, AL
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Jonesboro, Arkansas 72401
415
mi
from
Jonesboro, AR
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261
mi
from
Omaha, NE
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