Patient selection: MDS/MPN
Major criteria:
(1) increase in blast count in the bone marrow (see below)
(2) evidence of cytogenetic evolution (appearance of a new or previously present abnormality after complete cytogenetic remission, using FISH or karyotyping)
(3) new extramedullary disease (new or worsening splenomegaly, hepatomegaly, granulocytic sarcoma, skin lesions, etc)
Minor criteria:
(1) transfusion dependence
(2) increasing symptoms (>= 50% increase in MPN-SAF TSSII)
(3) molecular evidence of clonal evolution with increased mutational burden
(4) significant loss of maximal response on cytopenias (>= 50% decrease from maximum response in granulocytes or platelets)
(5) reduction in hemoglobin by >= 1.5 g/dL from baseline or best response
Diagnosis of progression - one or more of the following:
(1) >= 2 major criteria
(2) 1 major and >=2 minor criteria
(3) >= 3 minor criteria
|
Baseline Percent Blasts in Bone Marrow
|
Increase
|
New Percent
|
|
< 5%
|
>= 50%
|
> 5%
|
|
5-10%
|
>= 50%
|
> 10%
|
|
10-20%
|
>= 50%
|
> 20%
|
|
20-30%
|
>= 50%
|
> 30%
|
