Description:
This is a phase 2, open label study to assess umbralisib in combination with ublituximab in
subjects with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).
Title
- Brief Title: Study to Assess Umbralisib Plus Ublituximab in Patients With Treatment Naïve Follicular Lymphoma
- Official Title: A Phase II Study Evaluating the Safety and Efficacy of Umbralisib (TGR-1202) in Combination With Ublituximab in Patients With Treatment Naïve Follicular Lymphoma and Small Lymphocytic Lymphoma
Clinical Trial IDs
- ORG STUDY ID:
UTX-TGR-203
- NCT ID:
NCT03828448
Conditions
- Follicular Lymphoma
- Small Lymphocytic Lymphoma
Interventions
| Drug | Synonyms | Arms |
|---|
| Ublituximab | TG-1101 | ublituximab + umbralisib |
| Umbralisib | TGR-1202 | ublituximab + umbralisib |
Purpose
This is a phase 2, open label study to assess umbralisib in combination with ublituximab in
subjects with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma (SLL).
Detailed Description
The study will assess the safety and efficacy of umbralisib in combination with ublituximab
in subjects with treatment naïve Follicular Lymphoma (FL) and Small Lymphocytic Lymphoma
(SLL). Ublituximab will be administered through Cycle 12, while umbralisib will be
administered through cycle 24. After this time, subjects will be followed for PFS.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| ublituximab + umbralisib | Experimental | Ublituximab: 900 mg administered through Cycle 12, via IV infusion
Umbralisib: 800 mg administered through Cycle 24, via daily oral tablet | |
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of Follicular Lymphoma (FL) or Small Lymphocytic Lymphoma (SLL).
- Measurable disease that requires treatment
- ECOG performance status ≤ 1
Exclusion Criteria:
- Currently or previously received treatment for their lymphoma
- Received wide field radiotherapy within 28 days or limited field radiation within 14
days of Cycle 1 Day 1
- Evidence of hepatitis B virus, hepatitis C virus or known HIV infection
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Overall Response Rate |
| Time Frame: | Up to 24 months |
| Safety Issue: | |
| Description: | The sum of patients with partial responses and complete responses |
Secondary Outcome Measures
| Measure: | Progression-Free Survival |
| Time Frame: | From date of randomization to the date of first documented progression assessed up to 4 years |
| Safety Issue: | |
| Description: | |
| Measure: | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |
| Time Frame: | 12 months |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | TG Therapeutics, Inc. |
Trial Keywords
Last Updated
August 23, 2021
