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.
Title
- 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
Clinical Trial IDs
- ORG STUDY ID:
TGR-1202-202
- NCT ID:
NCT03364231
Conditions
- Waldenstrom Macroglobulinemia
Interventions
Drug | Synonyms | Arms |
---|
Umbralisib | TGR-1202 | Umbralisib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Umbralisib | Experimental | Umbralisib oral daily dose | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | N/A |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Overall Response Rate |
Time Frame: | Every 12 weeks, up to 2 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Progression-Free Survival |
Time Frame: | From date of randomization until the date of first documented progression, assessed up through 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | TG Therapeutics, Inc. |
Last Updated
August 23, 2021