Back to resultsStudy of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
Primary Purpose
Chronic Lymphocytic Leukemia, Richter Syndrome
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Umbralisib
ublituximab
TG-1501
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
- 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 14 days
- Known hepatitis B virus, hepatitis C virus or HIV infection
- Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
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
TG-1501 + Ublituximab + Umbralisib
Arm Description
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
Outcomes
Primary Outcome Measures
Determine Acceptable Adverse Events That Are Related to Treatment
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Secondary Outcome Measures
Overall Response Rate
The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy
Full Information
NCT ID
NCT02535286
First Posted
August 24, 2015
Last Updated
October 19, 2022
Sponsor
TG Therapeutics, Inc.
Collaborators
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02535286
Brief Title
Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
Official Title
Phase I Study of Ublituximab and Umbralisib in Combination With Targeted Immunotherapy in Patients With Relapsed-refractory Chronic Lymphocytic Leukemia (CLL) or Richter's Transformation (RT) of CLL
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 18, 2015 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TG Therapeutics, Inc.
Collaborators
Memorial Sloan Kettering Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of targeted immunotherapy in combination with ublituximab and umbralisib, in patients with advanced CLL or Richter's Transformation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia, Richter Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TG-1501 + Ublituximab + Umbralisib
Arm Type
Experimental
Arm Description
Ublituximab at a fixed IV infusion dose Days 1, 8 and 15 followed by maintenance infusions Umbralisib oral daily dose TG-1501 IV infusion at scheduled intervals
Intervention Type
Drug
Intervention Name(s)
Umbralisib
Other Intervention Name(s)
TGR-1202
Intervention Description
A once daily oral agent
Intervention Type
Biological
Intervention Name(s)
ublituximab
Other Intervention Name(s)
TG-1101
Intervention Description
IV anti-CD20 monoclonal antibody
Intervention Type
Biological
Intervention Name(s)
TG-1501
Intervention Description
IV immunotherapy for cancer
Primary Outcome Measure Information:
Title
Determine Acceptable Adverse Events That Are Related to Treatment
Description
To determine the incidence of adverse events, any potential abnormal laboratory results and any dose-limiting toxicities
Time Frame
6 months of therapy
Secondary Outcome Measure Information:
Title
Overall Response Rate
Description
The overall response rate (ORR) in patients with CLL and Richter's Transformation treated with Ublituximab in combination with Umbralisib and Targeted Immunotherapy
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 B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
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 14 days
Known hepatitis B virus, hepatitis C virus or HIV infection
Active autoimmune disorder (with the exception of autoimmune hemolytic anemia or ITP)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony R. Mato, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
TG Therapeutics Investigational Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10065
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 Trial Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
TG Therapeutics Investigational Trial Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation
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