Brief Title
Study to Assess the Efficacy and Safety of Umbralisib in Patients With Non-Follicular Indolent Non-Hodgkin's Lymphoma
Official Title
A Phase 2 Study to Assess the Efficacy and Safety of TGR-1202 (Umbralisib) Monotherapy in Patients With Non-Follicular Indolent Non-Hodgkin's Lymphoma
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 back or that has not responded to standard treatment.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Overall Response Rate
Secondary Outcome
Progression-Free Survival
Condition
Waldenstrom Macroglobulinemia
Intervention
Umbralisib
Study Arms / Comparison Groups
Umbralisib
Description: Umbralisib oral daily dose
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
21
Start Date
November 30, 2017
Completion Date
February 15, 2022
Primary Completion Date
February 15, 2022
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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Bruce Cheson, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03364231
Organization ID
TGR-1202-202
Responsible Party
Sponsor
Study Sponsor
TG Therapeutics, Inc.
Study Sponsor
Bruce Cheson, MD, Study Chair, Lombardi Comprehensive Cancer Center
Verification Date
May 2022