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

Active, not recruiting

• Conditions: NHL

• Registration Number: NCT04139252
• Lead Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland

Brief 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.

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Study Start: 2020-03-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26
• Primary Completion: 2023-06
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Patients diagnosed with newly diagnosed DLBCL (including HGBCL- NOS and HGBCL-DH) according to WHO classification 2016
• Ann Arbor stage II-IV
• Patients intended to be treated with 6 cycles R-CHOP (or DA-EPOCH-R) as first-line treatment (successive inclusion in HOVON 151 or HOVON 152 is possible)
• Age ≥ 18 years

Exclusion Criteria

• Patients with limited stage I, II disease planned to receive 3 cycles of R-CHOP + radiotherapy, or 4 x R-CHOP+ 2R

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tissue material	24 months	For genomic analysis and clinical outcome data

Trial Locations

Locations (60)

NL-Alkmaar-NWZ; 🇳🇱 Alkmaar, Netherlands

NL-Almelo-ZGTALMELO; 🇳🇱 Almelo, Netherlands

NL-Almere-FLEVOZIEKENHUIS; 🇳🇱 Almere, Netherlands

NL-Amersfoort-MEANDERMC; 🇳🇱 Amersfoort, Netherlands

NL-Amstelveen-AMSTELLAND; 🇳🇱 Amstelveen, Netherlands

NL-Amsterdam-AMC; 🇳🇱 Amsterdam, Netherlands

NL-Amsterdam-OLVG; 🇳🇱 Amsterdam, Netherlands

NL-Amsterdam-VUMC; 🇳🇱 Amsterdam, Netherlands

NL-Arnhem-RIJNSTATE; 🇳🇱 Arnhem, Netherlands

NL-Assen-WZA; 🇳🇱 Assen, Netherlands

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