At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 453 enrolled
Drug / intervention
Rituximab (RTX) +2 moredrug
Likely dose
Rituximab (RTX) 375 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Rituximab (RTX), Tafasitamab, and 1 other intervention for Diffuse Large B-cell Lymphoma. Completed, enrolled 453 participants across 158 sites in 23 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiffuse Large B-cell Lymphoma
CountriesAustralia, 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, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartNov 2016
Primary CompletionJun 2024
TodayJul 2026
First PostedMay 5, 2016
Enrollment StartNov 28, 2016
Primary CompletionJun 21, 2024
TodayJul 2, 2026
Enrollment to primary: 7.6 yearsPosted 10.2 years ago
Interventions
Rituximab (RTX)drug
Rituximab: Dose: 375 mg/m2 IV
Tafasitamabdrug
Tafasitamab: Tafasitamab dose: 12 mg/kg intravenously (IV)
Bendamustine (BEN)drug