Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Marginal Zone Lymphoma, Waldenstrom Macroglobulinemia, Non Follicular Indolent Non-Hodgkin Lymphoma

In brief

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 back or that has not responded to standard treatment.

Key facts

Study ID

NCT03364231

Run by

TG Therapeutics, Inc.

People needed

21

Starts

2017-11-30

Expected to finish

2022-02-15

Last updated by the study team

2023-06-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• TG Therapeutics Investigational Trial Site — Washington D.C., District of Columbia, United States
• TG Therapeutics Investigational Trial Site — Boston, Massachusetts, United States
• TG Therapeutics Investigational Trial Site — Hackensack, New Jersey, United States
• TG Therapeutics Investigational Trial Site — New York, New York, United States

Full record on ClinicalTrials.gov

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