CLL MRD harmonisation

Background

Treatment for CLL is now highly effective and MRD assessment is increasingly a core component in evaluating the response to current and new therapeutic strategies. A standardised 4-colour MRD assay developed by ERIC and the CLL research consortium is available but many centres have more advanced cytometers which allow simpler and more cost-effective approaches to be used.

Goals

To assess a single tube assay for the detection of CLL MRD in different laboratories across Europe and the US and facilitate the production of reproducible MRD information.

Approach

Reagents for the single-tube assay will be provided centrally. Participating centres will prepare samples according to their in-house standard laboratory procedures and acquire the data for the single-tube CLL MRD assay in parallel to their in-house analysis.

Participating centres will report the results of their analysis from in-house and single tube analysis. Data files for the single-tube assay will be re-analysed centrally and the performance characteristics assessed, primarily the detection of CLL MRD and the signal:noise for component reagents under varying laboratory conditions.

It is envisaged that the project will improve the reproducibility of MRD data from participant labs by providing a reference assay and identifying sources of variability.

Participants

Any centre can participate if they:

  1. have a flow cytometer capable of analysing 8 or more fluorochromes with the following laser/filter sets: Violet laser 450/50, 525/50; Blue laser 530/30, 575/26, 695/40, 780/60; Red laser 670/14, 780/60.
  2. will perform flow cytometry on at least 20 post-treatment samples from patients with CLL in a CR/PR after treatment within a six-month time period.

Time-line

  • review data end 2011
  • report findings at EHA 2012.

Coordination

Andy C. Rawstron, PhD
HMDS, Leeds Teaching Hospitals, UK
E-mail: