Back to resultsNovel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients
Primary Purpose
Hodgkin's Lymphoma
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
TGR-1202 + brentuximab vedotin
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin's Lymphoma focused on measuring Hodgkin's
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of Hodgkin's Lymphoma
- Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT
- 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. Patients who had prior Allogeneic hematologic stem cell transplant are excluded
Sites / Locations
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TGR-1202 + brentuximab vedotin
Arm Description
TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin
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) of TGR-1202 in combination with brentuximab vedotin in patients with Hodgkin's lymphoma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02164006
Brief Title
Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients
Official Title
A Multi-center Phase I/Ib Study Evaluating the Efficacy and Safety of Brentuximab Vedotin in Combination With TGR-1202, a Novel PI3K Delta Inhibitor, in Patients With Hodgkins Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 11, 2014 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (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 brentuximab vedotin in patients with hodgkin's lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma
Keywords
Hodgkin's
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TGR-1202 + brentuximab vedotin
Arm Type
Experimental
Arm Description
TGR-1202 oral daily dose in combination with a fixed IV infusion of brentuximab vedotin
Intervention Type
Drug
Intervention Name(s)
TGR-1202 + brentuximab vedotin
Other Intervention Name(s)
brentuximab vedotin: Adcetris
Intervention Description
TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin
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
21 days (1 cycle of therapy)
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
To assess the overall response rate (ORR) of TGR-1202 in combination with brentuximab vedotin in patients with Hodgkin's lymphoma
Time Frame
Up to 1 year
Other Pre-specified Outcome Measures:
Title
Duration of Response
Description
To evaluate the duration of response of TGR-1202 in combination with brentuximab vedotin
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 diagnosis of Hodgkin's Lymphoma
Relapsed or refractory after an autologous stem cell transplant (ASCT) or at least two prior multi-agent chemotherapy regimens in patients not candidates for ASCT
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. Patients who had prior Allogeneic hematologic stem cell transplant are excluded
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Diego
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Novel PI3K Delta Inhibitor TGR-1202, in Combination With Brentuximab Vedotin for Hodgkin's Lymphoma Patients
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