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)

Phase 2

Completed

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: Rituximab (RTX); Drug: Tafasitamab; Drug: Bendamustine (BEN)

• Registration Number: NCT02763319
• Lead Sponsor: Incyte Corporation

Brief 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.

Study Timeline

• Study First Submitted: 2016-04-30
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-05
• Study Start: 2016-11-28
• Primary Completion: 2024-06-21
• Study Completion: 2024-06-21
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rituximab and bendamustine	Rituximab (RTX)	Rituximab and bendamustine
Tafasitamab and bendamustine	Bendamustine (BEN)	Tafasitamab and bendamustine
Rituximab and bendamustine	Bendamustine (BEN)	Rituximab and bendamustine
Tafasitamab and bendamustine	Tafasitamab	Tafasitamab and bendamustine

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	From date of randomization until recurrence/disease progression, unacceptable toxicity, death or discontinuation for any other reason, whichever comes first assessed up to 4 yrs	To determine the efficacy of a combination of MOR00208 with BEN versus a combination of RTX with BEN in terms of progression-free survival (PFS) in: * Adult patients with R-R DLBCL (overall population); * A subgroup of adult patients with R-R DLBCL with low baseline peripheral blood NK-cell count (NKCC-low)

Secondary Outcome Measures

Name	Time	Method
Duration of response (DoR)	From date of randomization assessed up to 4 yrs	To determine efficacy
overall survival (OS)	From date of randomization assessed up to 4 yrs	To determine efficacy
time to progression (TTP)	From date of randomization assessed up to 4 yrs	To determine efficacy
time to next treatment (TTNT)	From date of randomization assessed up to 4 yrs	To determine efficacy
quality of life (QoL)	assessed up to 4 yrs	EORTC QLQ-C30 and EQ-5D-5L questionnaires will be used
Maximum Plasma Concentration of Tafasitamab (Cmax)	assessed up to 2 yrs
Apparent trough concentration (Cpd) of Tafsitamab	assessed up to 2 yrs
Objective response rate (ORR)	From date of randomization assessed up to 4 yrs	To determine efficacy
disease control rate (DCR)	From date of randomization assessed up to 4 yrs	To determine efficacy
Number of patients with adverse events	assessed up to 4 yrs	Number of participants with treatment- and non-treatment related adverse events as assessed by CTCAE
Number of patients developing Tafasitamab antibodies	assessed up to 2 yrs

Trial Locations

Locations (5)

MorphoSys Research Site; 🇬🇧 Southend on Sea, United Kingdom

Morphosys Research Site; 🇬🇧 Birmingham, United Kingdom

Morphosys Research site; 🇨🇿 Olomouc, Czechia

MorphoSys Research SIte; 🇦🇺 Garran, Australia

MorphoSys; 🇪🇸 Sabadell, Spain