Table 1.
Comment | Patients | Pts. with clinical progression (*1) | |||||
---|---|---|---|---|---|---|---|
(A) | Patients registered/included into the study | Patients included into the study (Inclusion period: 01-03-2012 - 31-03-2014) | 136 | 79 | |||
Patients with only diagnostic BM sample received (until 31-10-2018) | 83 | ||||||
Patients with BM samples for Flow-MRD analysis received (until 31-08-2018) | 53 | 29 | |||||
(B) | 1st flow RA (Flow-MRD analysis FU1) | Patients with BM samples received for 1st Flow-RA | 53 | ||||
Excluded patients not reaching RS of CR at 1st response assessment | 31 | 13 | |||||
Excluded patients (OFF-protocol) | 1 | 1 | |||||
Included patients with RS of CR/SCR at 1st response assessment | 21 | 14 | |||||
Included with adequate BM sample | 15 | ||||||
Excluded with inadequate BM sample | 6 | ||||||
(C) | Longitudinal flow-MRD analysis (FU1-FUX) | Patients with BM samples received for longitudinal analysis | 53 | ||||
Best reached RS during the patients course: <VGPR | 2 | 1 | |||||
Best reached RS during the patients course: VGPR | 11 | 10 | |||||
Best reached RS during the patients course: CR | 12 | 5 | |||||
Best reached RS during the patients course: sCR | 28 | 13 | |||||
Excluded patients (Off-protocol) | 2 | ||||||
Excluded patients not reaching CR over the entire patients course | 13 | ||||||
Excluded with inadequate BM samples (until progression) | 4 | ||||||
Included patients with reached RS CR/SCR over the patients course | 34 | ||||||
Included with ≥ 3 Flow-MRD samples analysed (incl. FU1) | 20 | 7 | |||||
Excluded with ≤ 2 Flow-MRD samples analysed (incl. FU1) | 14 | 7 |
Abbreviations: PR Partial response, VGPR Very good PR, CR Complete response, SCR Stringent CR, Flow-MRD MRD assessment using MFC, RA Response assessment, RS Clinical response category, FU Follow up (FU1 = 1st RA; FUX = subsequent follow ups), Pts Patients. Grey Boxes indicate patients included into the final analysis. (*1): at censoring date