MedTrace Logo

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)

NCT02763319 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 453

Last updated 2025-07-17

Study results available
· View outcomes & findings →

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.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

Rituximab (RTX)

Rituximab: Dose: 375 mg/m2 IV

DRUG

Tafasitamab

Tafasitamab: Tafasitamab dose: 12 mg/kg intravenously (IV)

DRUG

Bendamustine (BEN)

Sponsors & Collaborators

Principal Investigators

  • Incyte Medical Director · Incyte Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-28
Primary Completion
2024-06-21
Completion
2024-06-21

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02763319 on ClinicalTrials.gov