NCT04139252

A National Study for Blood Based Response Monitoring of B-cell Lymphoma Patients

A National Study for Blood Based Response Monitoring of Newly Diagnosed Aggressive B-cell Lymphoma (DLBCL and HGBCL) Patients

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Observational prospective study. Patients with DLBCL and HGBCL will be enrolled in the study to collect samples for developing a blood based assay allowing biomarker driven treatment in the future.

Detailed description

The rationale of this study is that, due to the lack of successful salvage options, first-line treatment outcome needs to be improved. To make this possible, a crucial condition is optimal identification of patients that will not be cured on R-CHOP. The aim of this protocol is to develop new tools to monitor treatment response and disease outcome. Molecular monitoring of treatment response through liquid biopsies (LB) is such a promising new tool. The primary objective is to collect liquid biopsy samples of patients with newly diagnosed DLBCL/HGBCL to develop a blood based assay allowing biomarker driven treatment in the future. The secondary objectives are to collect clinical data and pre-treatment tissue samples (for determining molecular profiles) to allow for correlation to the blood based assay. This study is designed for patients with newly diagnosed DLBCL and HGBCL ≥ 18 yr.

Conditions

• NHL

Interventions

Type	Name	Description
OTHER	No intervention	No intervention

Timeline

• Start date: 2020-03-17
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2019-10-25
• Last updated: 2023-04-26

Locations

60 sites across 1 country: Netherlands