Phase 2
N=21
Study to Assess the Efficacy and Safety of Umbralisib in Participants With Non-Follicular Indolent Non-Hodgkin's Lymphoma
Marginal Zone Lymphoma · Waldenstrom Macroglobulinemia · Non Follicular Indolent Non-Hodgkin Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT03364231 ↗Enrolled (actual)
21
Serious AEs
4.8%
Results posted
Jun 2023
Primary outcome: Primary: Overall Response Rate (ORR) as Assessed by Revised Response Criteria for Non- Hodgkin's Lymphoma (Lugano Classification) and Consensus-Based 6th International Workshop on Waldenstrom's Macroglobulinemia (IWWM) — 37.5; 30.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Umbralisib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- TG Therapeutics, Inc.
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) as Assessed by Revised Response Criteria for Non- Hodgkin's Lymphoma (Lugano Classification) and Consensus-Based 6th International Workshop on Waldenstrom's Macroglobulinemia (IWWM) |
37.5; 30.0 | — |
| PRIMARY Duration of Response (DOR) |
21.2; 13 | — |
| SECONDARY Complete Response (CR) Rate |
12.5; 0 | — |
| SECONDARY Progression-Free Survival (PFS) |
47.1; 18.4 | — |
| SECONDARY Time to Treatment Failure (TTF) |
13.1; 6.5 | — |
| SECONDARY Number of Participants With at Least One Adverse Event (AE) |
8; 13 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03364231). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.