Status:
TERMINATED
Study to Assess Umbralisib Plus Ublituximab in Participants With Treatment Naïve Follicular Lymphoma
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
Follicular Lymphoma
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a phase 2, open label study to assess umbralisib in combination with ublituximab in participants with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).
Detailed Description
The study will assess the safety and efficacy of umbralisib in combination with ublituximab in participants with treatment naïve FL and SLL. Ublituximab will be administered through Cycle 12, while um...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of FL or SLL.
- Measurable disease that requires treatment
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Exclusion
- Currently or previously received treatment for their lymphoma
- Received wide field radiotherapy within 28 days or limited field radiation within 14 days of Cycle 1 Day 1
- Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus (HIV) infection
Key Trial Info
Start Date :
July 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03828448
Start Date
July 10 2019
End Date
May 31 2022
Last Update
July 24 2023
Active Locations (3)
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1
TG Therapeutics Investigational Trial Site
Fort Myers, Florida, United States, 33901
2
TG Therapeutics Investigational Trial Site
St. Petersburg, Florida, United States, 33705
3
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, United States, 37203