TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
This trial is active, not recruiting.
|Condition||chronic lymphocytic leukemia|
|Treatment||tgr-1202 + obinutuzumab + chlorambucil|
|Sponsor||TG Therapeutics, Inc.|
|Start date||March 2014|
|End date||August 2016|
|Trial size||30 participants|
|Trial identifier||NCT02100852, TGR-GA-106|
The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil in patients with chronic lymphocytic leukemia.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Maximum Tolerated Dose acceptable for participants
time frame: 28 days (1 cycle of therapy)
Overall Response Rate
time frame: Up to 1 year
Male or female participants at least 18 years old.
Inclusion Criteria: - Confirmed Chronic Lymphocytic Leukemia (CLL) - Eastern Cooperative Oncology Group (ECOG) score of 0 to 2 - Ability to swallow oral medication Exclusion Criteria: - Known hepatitis B virus, hepatitis C virus or HIV infection - Primary central nervous system lymphoma or known intracranial involvement - Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months
|Official title||A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of TGR-1202, a Novel PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)|
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