1. Home
  2. Additional clinical information

Acute lymphoblastic leukaemia ALL06 - Definition of risk groups

This document is a quick and concise evidence-based summary to provide additional information, instruction, or guidance to complement a treatment protocol or clinical resource document. 

Minimal residual disease (MRD) is used to stratify patients into risk groups. For information on which protocol is used for each risk group, refer to the indications and patient population section of the individual ALL06 protocol, the overall ALL06 treatment schema and the ALL06 protocol flow diagram.

Definition of risk groupsr

Standard risk (SR) Medium risk (MR) Medium-High risk (MHR) High risk (HR) Very high risk (VHR)
  • Prednisolone good response on day 8 (blast count < 1.0 x109/L in peripheral blood after 7 days of prednisolone and one intrathecal injection of methotrexate on day1).
  • Negative for t(4:11) and MLL/AF4.
  • Complete remission on day 33 (time point 1) marrow biopsy.
  • Either precursor-B or T lineage.
  • MRD must be negative on day 33 (time point 1) and at day 79 (time point 2), (day 1 of Protocol M), measured with a sensitivity of ≤ 10-4. 
  • Normal marrow cellularity is not required for assessment of day 33 (time point 1) complete remission.
  • Prednisolone good response as for SR.
  • Negative for t(4:11) and MLL/AF4.
  • Complete remission on day 33 marrow biopsy.
  • Either precursor-B or T lineage
  • MRD criteria not fulfilled for standard risk, high risk, or very high risk, or not tested/no result.
  • MRD may be positive on day 33 (time point 1) but must be negative on day 79 (time point 2) to remain in the medium risk group.
  • Extramedullary disease at diagnosis does not exclude patients from this group.
  • Prednisolone good response on day 8 (blast count < 1.0 x109/L in peripheral blood after 7 days of prednisolone and one intrathecal injection of methotrexate on day1).
  • Negative for t(4:11) and MLL/AF4.
  • Complete remission on day 33 (time point 1) marrow biopsy.
  • Either precursor-B or T lineage.
  • MRD criteria not fulfilled for standard risk, high risk, or very high risk, or not tested/no result.
  • Normal marrow cellularity at diagnosis does not exclude patients from this group.
  • Prednisolone poor response (peripheral blood blast count ≥ 1.0 x109/L on day 8).
  • Patient must be pre-B phenotype (CD10+, CD19+) phenotype and have WCC < 100 x109/L, not be T lineage or pro-B cell (CD10-, CD19+) phenotype, negative for t(4,11) and MLL/AF4.
  • Complete remission on day 33 (time point 1) marrow biopsy.
  • MRD positive but < 5 x10-4 on day 79 (time point 2) or unknown.
  • MRD: ≥ 5 x 10-4 at time point 2.
  • Prednisolone poor response and either T cell, pro-B, or WCC ≥ 100 x109/L.
  • Positive for t(4:11) or MLL/AF4.
  • Day 33 (time point 1) marrow biopsy not in complete remission (i.e. ≥ 5% leukaemic blasts).
On this page
Expand all Collapse all Back to top
[%id%]
[%title%]
[%abstract%]

Version 1

Date Summary of changes
24/11/2020 Document developed with ALL06 protocols, reviewed by Haematology Reference Committee.
29/03/2021 Published on eviQ website. Version 1. Review in 1 year.

Version 2

Date Summary of changes
29/11/2022 Document reviewed electronically by Haematology Reference Committee. Updates include:
  • Document title updated to align with ALL06 protocol titles.
  • Reference update - study data published for ALL06.
  • Removed 'interim' from title.
15/05/2023

Approved and published as version number v.2.

For review in 2 years.

While every effort has been made to ensure the accuracy of the content at the time of publication, the Cancer Institute NSW does not accept any liability, with respect to loss, damage, injury or expense arising from any such errors or omission in the contents of this work. Any reference to specific pharmaceuticals and/or medical products as examples does not imply endorsement of any of these products. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information source. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

Send feedback for this page

First approved:
Last reviewed:
Review due:

The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/3910

16 Apr 2024