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

Status: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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

Locations & Contacts

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: Active
Name Not Available

Massachusetts

Boston
Brigham and Women's Hospital
Status: Active
Name Not Available
Dana-Farber Cancer Institute
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
TG Therapeutics Inc

Trial IDs

Primary ID TGR-1202-202
Secondary IDs NCI-2018-00242
Clinicaltrials.gov ID NCT03364231