VERLEN - Phase II, Open-Label Study evaluating efficacy of Lenalidomide and Tafasitamab combination associated to Rituximab in frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or older

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507286-25-00

Acronym

VERLEN

Enrollment

Registered

2024-01-10

Start date

2021-12-23

Completion date

Unknown

Last updated

2025-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-Cell Lymphoma

Brief summary

ORR encompasses patients that reach Complete Metabolic Response or Partial Metabolic Response based on investigator disease assessment according to Lugano Response Criteria.

Detailed description

Central review of PET-CT according to Lugano Response Criteria, Complete Metabolic response (CMR) rates based on investigator disease assessment and central assessment, Overall Survival (OS), Quality of Life (QoL), Progression Free Survival (PFS), Assess safety of lenalidomide and tafasitamab in the context of patients treated by rituximab

Interventions

DRUGMabThera 500 mg concentrate for solution for infusion

DRUGCYCLOPHOSPHAMIDE

DRUGMINJUVI 200 mg powder for concentrate for solution for infusion

DRUGPREDNISONE ARROW 20 mg

DRUGcomprimé sécable

DRUGZelvina 20 mg hard capsules

DRUGMabThera 1400 mg solution for subcutaneous injection

DRUGDOXORUBICIN

DRUGONCOVIN 1 mg

DRUGsolution injectable

DRUGVINCRISTINE

Eligibility

Sex/Gender

All

Age

65 Years to No maximum

Design outcomes

Primary

Measure	Time frame
ORR encompasses patients that reach Complete Metabolic Response or Partial Metabolic Response based on investigator disease assessment according to Lugano Response Criteria.	—

Secondary

Measure	Time frame
Central review of PET-CT according to Lugano Response Criteria, Complete Metabolic response (CMR) rates based on investigator disease assessment and central assessment, Overall Survival (OS), Quality of Life (QoL), Progression Free Survival (PFS), Assess safety of lenalidomide and tafasitamab in the context of patients treated by rituximab	—

Countries

Belgium, France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026