Status:
COMPLETED
Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
Marginal Zone Lymphoma
Waldenstrom Macroglobulinemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This research study will evaluate the safety and efficacy of a study drug called Umbralisib (also known as TGR-1202) alone as a possible treatment for Waldenstrom's Macroglobulinemia that has come bac...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of Waldenstroms Macroglobulinemia
- Relapsed or refractory after at least one prior treatment regimen
- Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
Exclusion
- Any major surgery, chemotherapy or immunotherapy within the last 21 days
- Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
- Prior autologous stem cell transplant within 6 months of study entry
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 15 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03364231
Start Date
November 30 2017
End Date
February 15 2022
Last Update
June 23 2023
Active Locations (4)
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1
TG Therapeutics Investigational Trial Site
Washington D.C., District of Columbia, United States, 20007
2
TG Therapeutics Investigational Trial Site
Boston, Massachusetts, United States, 02215
3
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, United States, 07601
4
TG Therapeutics Investigational Trial Site
New York, New York, United States, 10065