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Clinical picture: NHL (Non Hodgkin Lymphoma)

Trial: HOVON 902 DLBCL


News
1. Overview
Study details
2. Patient eligibility criteria
3. Registration (& randomization) of patients
4. Participating parties
5. Participating sites
6. Instruction videos
7. Download documentation / forms


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News


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1. Overview



Summary

A national study for blood based response monitoring of newly diagnosed aggressive B-cell lymphoma (DLBCL and HGBCL) patients


Status

planned


Study details



Echelon level

Level D


Type of monitoring for this study

None


Target number of patients

250


Date of first EC&CA submission

25-Jul-2019


Study objectives

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.


2. Patient eligibility criteria



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


3. Registration (& randomization) of patients



Registration

Eligible patients should be registered before start of treatment. Patients need to be registered at the HOVON Data Center by one of the following options:
♦ By ALEA; select the [patient] tab and click the [Add new patient] button. Complete all items and click the [Submit] button
♦ By faxing the completed registration/randomization CRF +31.10.7041028 Monday through Friday, from 09:00 to 17:00 CET
♦ By phone +31.10.7041560 Monday through Friday, from 09:00 to 17:00


4. Participating parties



5. Participating sites



6. Instruction videos



7. Download documentation / forms




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