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Table 1 The clinical characteristics of patients enrolled on the study

From: WT1 peptide vaccine in Montanide in contrast to poly ICLC, is able to induce WT1-specific immune response with TCR clonal enrichment in myeloid leukemia

Patient no

Diagnosis

Arm

Prior treatments

Disease status at vaccination

WT1 treatment

Treatment after WT1

Severe toxicities

Current status

PFS (days)

1

CML myeloid blast phase

WT1 in Montanide

Failed ponatinib, had MRD SCT with active disease

Morphologic residual disease with molecule disease

s/p 6 WT1 vaccination, tolerated well

DLI 40 days after last WT1 vaccination

No

Died from infection with GVHD

463

2

HLA

A0202

Relapsed AML with normal karyotype

WT1 in poly ICLC

CR after induction, 2 cycle HiDAC consolidation, relapse 7 months later, CR2 with clinical trial

Morphologic residual disease, with cytogenetic changes

s/p 6 WT1 vaccination, tolerated well

Disease progressed, and died from disease

Admitted for viral infection (not related)

Died due to disease progression

186

3

t-AML, t (8,21), del 9q

WT1 in poly ICLC

CR1 after induction and consolidation

Morphologic and cytogenetic remission

s/p 9 WT1 vaccination;

tolerated well

Off study due to FDA hold of the study

No

In remission

1731

4

MDS RAEB2

WT1 in poly ICLC

CR after MUD SCT

Morphologic and cytogenetic remission

s/p 9 WT1 vaccination;

tolerated well

Off study due to FDA hold of the study

No

In remission

1675

5

Relapsed AML after allo-SCT

WT1 in Montanide

CR after 2rd haplo-cord SCT

Morphologic and cytogenetic remission

s/p 7 WT1 vaccination;

tolerated well

Off study with neurologic complication

Myelitis after bacterial meningitis

Died in remission

239

6

AML with normal karyotype

WT1 in Montanide

CR after induction/1 cycle consolidation,

Morphologic remission but cytogenetic revolution with 17p deletion

s/p 12 WT1 vaccine

Disease relapsed 18 months after vaccine, treated with decitabine

Developed aseptic ulcer at vaccine sites of 12, 11, 10, and erythema at the 1st vaccine site

Relapsed, Died from disease progression

832

7

AML with complex karyotype

WT1 in Montanide

CR1 after induction, 3 cycle consolidation

Morphologic and cytogenetic remission

s/p 8 WT1, tolerated well, but had disease relapse

Disease progressed after 4 cycle 10 day decitabine

No

Died from disease progression

169