Table 2. Proposition for MRD response... | American Society of Hematology

Table 2.

Proposition for MRD response criteria in MDS

Category	Defining criteria
MRD_CR	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
MRD_LL	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, MRD_CR 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 MRD_CR, MRD_LL, 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†

Category	Defining criteria
MRD_CR	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
MRD_LL	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, MRD_CR 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 MRD_CR, MRD_LL, 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%); MRD_CR, complete MRD response.

International Working Group 2023 response criteria (unchanged from IWG 2006).⁹

Corroboration via sorted donor chimerism analyses is recommended.