Table 2.
Proposition for MRD response criteria in MDS
| Category | Defining criteria |
|---|---|
| MRDCR | CCyR∗ or normal karyotype, and complete MRD response: negative results (lower LOD at least 0.1%) in all MRD tests (NGS, MFC, and PCR) that were used |
| MRDLL | CCyR∗ or normal karyotype, and any MRD above the LOD of the assay but below the level of 0.1% |
| MRD+ | CCyR∗ or normal karyotype, and any MRD tests positive ≥0.1% |
| –DTA+/− | Used as an additional MRD test qualifier: eg, MRDCR DTA+ and MRD+ DTA− |
| MFC-MRD− | MFC is used as a standalone test without other genetic or molecular tests MFC-MRD–: no detection of any leukemic clones using MFC (lower LOD, 0.1%) |
| MFC-MRD+ | MFC is used as a standalone test without other genetic or molecular tests MFC-MRD+: detection of leukemic clones using MFC with a frequency ≥ 0.1% |
| MRD relapse | Previous documentation of MRDCR, MRDLL, or MFC-MRD− after treatment MRD relapse confirmed in a second consecutive samples Newly detected MRD+ Newly detected MFC-MRD+ Greater or equal to 1 log10 increase of VAF of previously detected DTA variants after day +100 of allogeneic HCT† |
DTA, DNMT3A, TET2, and ASXL1; LL, low level of detection (<0.1%); MRDCR, complete MRD response.
∗
International Working Group 2023 response criteria (unchanged from IWG 2006).9
†
Corroboration via sorted donor chimerism analyses is recommended.