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Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

A Phase 1b/2, Open-Label, Multicenter Study to Evaluate the Safety and Pharmacokinetics of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

NCT05222555•Incyte Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Capable of giving signed informed consent
•2. Age 18 years or older
•3. Histologically confirmed diagnosis of DLBCL
•4. Tumor tissue for retrospective central pathology review must be provided as an adjunct to participation in this study.
•5. Patients must have:
•* relapsed and/or refractory disease
•* at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
•* received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must have included a CD20-targeted therapy
•* Eastern Cooperative Oncology Group 0 to 2
•6. Patients not considered in the opinion of the investigator eligible to undergo intensive salvage therapy including ASCT
+8 more criteria

Exclusion Criteria

•1. Patients who are legally institutionalized or concurrent enrollment in another interventional clinical study
•2. Patients who have:
•* other histological type of lymphoma
•* a history of "double/triple hit" genetics
•3. Patients who have, within 14 days prior to Day 1 dosing:
•* not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
•* undergone major surgery (with 4 weeks) or suffered from significant traumatic injury
•* received live vaccines (within 4 weeks).
•* required parenteral antimicrobial therapy for active, intercurrent infections
•4. Patients who:
+21 more criteria

Locations (62)

Morristown Memorial Hospital

Morristown, New Jersey, United States

Texas Oncology-Baylor Charles A. Sammons Cancer Center - USOR

Dallas, Texas, United States

Vista Oncology

Olympia, Washington, United States

UK St. Pölten

Sankt Pölten, Lower Austria, Austria

Klinikum Wels Grieskirchen

Wels, Upper Austria, Austria

Universitatsklinikum Salzburg

Salzburg, Austria

Fakultni nemocnice Brno

Brno, Czechia

Fakultni nemocnice Ostrava

Ostrava, Czechia

Fakultni nemocnice Kralovske Vinohrady

Prague, Czechia

Vseobecna Fakultni Nemocnice V Praze

Prague, Czechia

Key Dates

Start Date

July 19, 2022

Primary Completion Date

July 17, 2024

Completion Date

November 30, 2027

Last Updated

January 16, 2026

Enrollment

ACTUAL participants

Conditions

Diffuse Large B Cell Lymphoma

Interventions

Tafasitamab

DRUG

Lenalidomide

DRUG

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B-cell MalignancyMarginal Zone Lymphoma+7 more

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RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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