Trials / Completed
CompletedNCT02763319
A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)
A Phase 2/3, Randomised, Multicentre Study of Tafasitamab With Bendamustine Versus Rituximab With Bendamustine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL) Who Are Not Eligible for High-Dose Chemotherapy (HDC) and Autologous Stem-Cell Transplantation (ASCT)
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 453 (actual)
- Sponsor
- Incyte Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to compare the safety and efficacy of Tafasitamab with BEN versus RTX with BEN in adult patients with relapsed of refractory DLBCL.
Detailed description
This is a randomised, two-arm, multicentre, open-label phase II/III efficacy and safety study of Tafasitamab in combination with BEN versus RTX in combination with BEN given to adult patients who have relapsed after or are refractory to at least one but no more than three prior systemic therapies and have failed, or are not candidates for HDC and ASCT, and have thus exhausted their therapeutic options of demonstrated clinical benefit. At least one prior therapy line must have included a CD20-targeted therapy.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rituximab (RTX) | Rituximab: Dose: 375 mg/m2 IV |
| DRUG | Tafasitamab | Tafasitamab: Tafasitamab dose: 12 mg/kg intravenously (IV) |
| DRUG | Bendamustine (BEN) |
Timeline
- Start date
- 2016-11-28
- Primary completion
- 2024-06-21
- Completion
- 2024-06-21
- First posted
- 2016-05-05
- Last updated
- 2025-07-17
- Results posted
- 2025-07-17
Locations
158 sites across 23 countries: United States, Australia, Austria, Canada, Croatia, Czechia, Finland, France, Germany, Hungary, Israel, Italy, New Zealand, Poland, Portugal, Romania, Serbia, Singapore, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02763319. Inclusion in this directory is not an endorsement.