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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04139252

Acronym

HO902DLBCL

Enrollment

250

Registered

2019-10-25

Start date

2020-03-17

Completion date

2023-06-30

Last updated

2023-04-26

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

Conditions

NHL

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.

Interventions

OTHERNo intervention

No intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Tissue material	24 months	For genomic analysis and clinical outcome data

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026