Back to resultsTGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TGR-1202 + Obinutuzumab + Chlorambucil
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia
Eligibility Criteria
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
Sites / Locations
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TGR-1202 + Obinutuzumab + Chlorambucil
Arm Description
TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.
Outcomes
Primary Outcome Measures
Maximum Tolerated Dose acceptable for participants
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Secondary Outcome Measures
Overall Response Rate
To assess the overall response rate (ORR) in patients with chronic lymphocytic leukemia treated with TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02100852
Brief Title
TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
March 12, 2014 (Actual)
Primary Completion Date
November 2017 (Actual)
Study Completion Date
November 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TGR-1202 + Obinutuzumab + Chlorambucil
Arm Type
Experimental
Arm Description
TGR-1202 is an oral daily dose with obinutuzumab at a fixed IV infusion and chlorambucil as an oral dose on specified days.
Intervention Type
Drug
Intervention Name(s)
TGR-1202 + Obinutuzumab + Chlorambucil
Other Intervention Name(s)
Obinutuzumab: Gazyva, Chlorambucil: Leukeran
Intervention Description
TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose
Primary Outcome Measure Information:
Title
Maximum Tolerated Dose acceptable for participants
Description
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Time Frame
28 days (1 cycle of therapy)
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
To assess the overall response rate (ORR) in patients with chronic lymphocytic leukemia treated with TGR-1202 in combination with obinutuzumab (Gazyva) and chlorambucil
Time Frame
Up to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
12. IPD Sharing Statement
Learn more about this trial
TGR-1202, a PI3K Delta Inhibitor, in Combination With Obinutuzumab and Chlorambucil in Patients With Chronic Lymphocytic Leukemia (CLL)
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