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Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients

NCT05222555 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2026-01-16

Study results available
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Summary

This is an open-label, multicentre study too Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined with Lenalidomide (LEN) in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) who have had at least one, but no more than three prior systemic regimens and who are not eligible for high dose chemotherapy (HDC) with autologous stem-cell transplantation (ASCT) at the time of study entry.

Conditions

Interventions

DRUG

Tafasitamab

tafasitamab will be administered intravenously at protocol defined timepoints

DRUG

Lenalidomide

lenalidomide will be administered orally at protocol defined timepoints

Sponsors & Collaborators

Principal Investigators

  • Incyte Medical Director · Incyte Corporation

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-19
Primary Completion
2024-07-17
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Czechia
  • France
  • Israel
  • Italy
  • Poland
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT05222555 on ClinicalTrials.gov