Back to resultsExtension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials
Primary Purpose
Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
TGR-1202
TGR-1202 + Ublituximab
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.
- Subjects must have completed at least 6 cycles of therapy on their current protocol.
Exclusion Criteria:
- Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.
Sites / Locations
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Site
- TG Therapeutics Investigational Trial Site
- TG Therapeutics Investigational Trial Site
- 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 2
Arm Type
Experimental
Experimental
Arm Label
TGR-1202
TGR-1202 + Ublituximab
Arm Description
Oral TGR-1202 Daily
Oral TGR-1202 in combination with Ublituximab intravenous administration
Outcomes
Primary Outcome Measures
Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities
Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)
Secondary Outcome Measures
Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment
Date of progression reported for each patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03207256
Brief Title
Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials
Official Title
An Open Label Extension Trial of Ublituximab and/or Umbralisib (TGR-1202) in Combination With Other Novel Agents or as Single Agents in Subjects Currently Receiving Treatment on a TG Therapeutics Study.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Strategic/Business Decision
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
May 25, 2022 (Actual)
Study Completion Date
June 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is an open label compassionate use trial of Ublituximab and TGR-1202 in combination or as single agents in patients currently receiving treatment on Ublituximab and/or TGR-1202 trials with B-cell Non-Hodgkin's Lymphoma or 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, Non Hodgkin Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TGR-1202
Arm Type
Experimental
Arm Description
Oral TGR-1202 Daily
Arm Title
TGR-1202 + Ublituximab
Arm Type
Experimental
Arm Description
Oral TGR-1202 in combination with Ublituximab intravenous administration
Intervention Type
Drug
Intervention Name(s)
TGR-1202
Intervention Description
Oral Daily TGR-1202
Intervention Type
Drug
Intervention Name(s)
TGR-1202 + Ublituximab
Intervention Description
Oral Daily TGR-1202 + Ublituximab IV Administration
Primary Outcome Measure Information:
Title
Adverse Events of TGR-1202 and/or TGR-1202 + ublituximab treatment, including delayed toxicities
Description
Toxicity according to the investigator (Adverse events with NCI-CTC 4.0)
Time Frame
Evaluated at each planned visit through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Progression-free survival of TGR-1202 and/or TGR-1202 + ublituximab treatment
Description
Date of progression reported for each patient
Time Frame
Evaluated at each planned visit through study completion, an average of 2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must be currently receiving treatment with ublituximab and/or TGR-1202 on a previously approved protocol.
Subjects must have completed at least 6 cycles of therapy on their current protocol.
Exclusion Criteria:
Subject progressed while receiving therapy with ublituximab and/or TGR-1202 while participating in their immediate previous trial.
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
Tucson
State/Province
Arizona
ZIP/Postal Code
85711
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
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
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46804
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
TG Therapeutics Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Denton
State/Province
Texas
ZIP/Postal Code
76210
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Extension Trial of Ublituximab and TGR-1202 in Combination or as Single Agents in Subjects Currently Receiving Treatment on Ublituximab and/or TGR-1202 Trials
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