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A National Study for Blood Based Response Monitoring of B-cell Lymphoma Patients (HO902DLBCL)

S

Stichting Hemato-Oncologie voor Volwassenen Nederland

Status

Active, not recruiting

Conditions

NHL

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No 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

Trial contacts and locations

60

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Data sourced from clinicaltrials.gov

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