Trials / Terminated
TerminatedNCT02793583
Study to Assess the Efficacy and Safety of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkins Lymphoma
A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib With or Without Bendamustine and Umbralisib Alone in Patients With Previously Treated Non-Hodgkin's Lymphoma
- Status
- Terminated
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 710 (actual)
- Sponsor
- TG Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Unity NHL - A Phase 2b Randomized Study to Assess the Efficacy and Safety of the Combination of Ublituximab + Umbralisib with or without Bendamustine and Umbralisib alone in Patients with Previously Treated Non-Hodgkin's Lymphoma
Detailed description
The purpose of this study is to evaluate the efficacy and safety of umbralisib monotherapy and the umbralisib + ublituximab (U2) combination in aggressive and indolent lymphomas and to also explore the U2 regimen in combination with bendamustine in the treatment of NHL (FL, SLL, MZL, DLBCL and MCL).
Conditions
- Diffuse Large B-Cell Lymphoma
- Follicular Lymphoma
- Marginal Zone Lymphoma
- Mantle Cell Lymphoma
- Small Lymphocytic Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Ublituximab | |
| DRUG | Umbralisib | |
| BIOLOGICAL | Bendamustine |
Timeline
- Start date
- 2016-05-25
- Primary completion
- 2022-05-31
- Completion
- 2022-07-04
- First posted
- 2016-06-08
- Last updated
- 2022-07-21
Locations
168 sites across 9 countries: United States, Australia, Israel, Italy, Poland, Slovakia, South Korea, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT02793583. Inclusion in this directory is not an endorsement.