Patient characteristics
Patient no. . | Age, y . | Type . | Karyotype . | Previous therapy . | Disease status baseline . | Cohort . | No. of vacc . | Blasts in BM baseline . | Best response, IWG . | PFS, d . | Best response modified criteria . | Duration of early progression, d . | mPFS, d . | Clinical response comments . | Tetramer+ T cells in pB baseline . | Tetramer response in pB following vacc . | Tetramer response in BM following vacc . | Cytokine response in pB following vacc . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 66 | M4 | Normal | 2× ind. reind. | 2. PR | 1 | 12 | 10 | PD | 21 | mCR (17 mo) | 65 | 514 | − | − | + | + | + |
2 | 82 | M2 | na | None | PD | 1 | 4 | 85 | SD | 136 | SD | − | 136 | Off protocol after 4 vacc due to soft tissue infectious complications | − | + | + | + |
3 | 64 | M6 | Complex 5q− | 2× ind. | PD | 1 | 4 | 60 | PD | 50 | PD | − | 50 | − | + | − | − | − |
4 | 72 | M2 | Normal | Ind. | 1. PR | 1 | 6 | 5 | PD | 37 | PD | − | 37 | − | − | + | + | + |
5 | 74 | M1 | 47 XX + 11 46 XX (23) | 2× ind.reind. | 2. PR | 1 | 9 | 12,5 | SD | 201 | SD | − | 201 | − | + | − | − | + |
6 | 45 | M7 | Normal | 3× ind reind. | PD | 1 | 4 | 60 | PD | 49 | PD | − | 49 | − | − | − | − | − |
7 | 73 | WHO II | Normal | None | PD | 1 | 12 | 70 | SD | 262 | SD | − | 262 | Erythroid response for 7 months | − | + | − | − |
8 | 63 | WHO II | Normal | None | PD | 1 | 18 | na | SD | 101 | SD | − | 101 | − | − | + | + | + |
9 | 80 | M4 | Normal | None | PD | 1 | 8 | 80 | PD | 60 | mSD | 82 | 144 | Decrease of peripheral blasts | + | − | + | + |
10 | 59 | M4 | Normal | 2× ind. reind. autoPBSCT | 3. PR | 2 | 4 | 5–10 | PD | 29 | PD | − | 29 | − | na | na | na | na |
11 | 65 | M4 | Normal | Ind. | PD | 2 | 12 | 10 | SD | 134 | SD | − | 134 | − | − | − | − | − |
12 | 67 | RAEBII | Normal | None | PD | 2 | 24 | 12 | Major neutrophil response | 112 | mSD | 231 | 339 | − | + | + | + | + |
13 | 61 | WHO II | Normal | None | PD | 2 | 11 | 60 | SD | 142 | SD | − | 142 | − | − | + | − | − |
14 | 69 | RAEB I | Normal | ATG, CsA | PD | 2 | 10 | 10 | Major neutrophil response | 69 | Major neutrophil response | − | 69 | − | − | − | − | − |
15 | 75 | WHO II | Complex | None | PD | 2 | 10 | 60 | SD | 132 | SD | − | 132 | Decrease of marrow blasts (30% at 3 months) | − | − | + | + |
16 | 82 | M4 | Normal | None | PD | 2 | 11 | 50 | PD | 66 | mSD | 112 | 137 | − | + | + | + | |
17 | 65 | M2 | Trisomy 8 | 1× ind. 2× cons. | 1. PR | 2 | 27+ | 5 | SD ongoing | SD ongoing | − | 571 (+) | Erythroid response after 4 months, molecular response with complete disappearance of trisomy 8 | − | + | + | + | |
18 | 58 | M2 | Normal | None | PD | 2 | 23+ | 40 | SD ongoing | 506 (+) | SD ongoing | − | 506 (+) | Decrease of marrow blasts (12% at 3 months) | − | − | − | − |
19 | 69 | WHO II | 46 XX (del5) | Low araC | 1. PR | 2 | 11 | 30 | SD | 168 | SD | 168 | Blast response at 3 months (15%) | − | + | − | + |
Patient no. . | Age, y . | Type . | Karyotype . | Previous therapy . | Disease status baseline . | Cohort . | No. of vacc . | Blasts in BM baseline . | Best response, IWG . | PFS, d . | Best response modified criteria . | Duration of early progression, d . | mPFS, d . | Clinical response comments . | Tetramer+ T cells in pB baseline . | Tetramer response in pB following vacc . | Tetramer response in BM following vacc . | Cytokine response in pB following vacc . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 66 | M4 | Normal | 2× ind. reind. | 2. PR | 1 | 12 | 10 | PD | 21 | mCR (17 mo) | 65 | 514 | − | − | + | + | + |
2 | 82 | M2 | na | None | PD | 1 | 4 | 85 | SD | 136 | SD | − | 136 | Off protocol after 4 vacc due to soft tissue infectious complications | − | + | + | + |
3 | 64 | M6 | Complex 5q− | 2× ind. | PD | 1 | 4 | 60 | PD | 50 | PD | − | 50 | − | + | − | − | − |
4 | 72 | M2 | Normal | Ind. | 1. PR | 1 | 6 | 5 | PD | 37 | PD | − | 37 | − | − | + | + | + |
5 | 74 | M1 | 47 XX + 11 46 XX (23) | 2× ind.reind. | 2. PR | 1 | 9 | 12,5 | SD | 201 | SD | − | 201 | − | + | − | − | + |
6 | 45 | M7 | Normal | 3× ind reind. | PD | 1 | 4 | 60 | PD | 49 | PD | − | 49 | − | − | − | − | − |
7 | 73 | WHO II | Normal | None | PD | 1 | 12 | 70 | SD | 262 | SD | − | 262 | Erythroid response for 7 months | − | + | − | − |
8 | 63 | WHO II | Normal | None | PD | 1 | 18 | na | SD | 101 | SD | − | 101 | − | − | + | + | + |
9 | 80 | M4 | Normal | None | PD | 1 | 8 | 80 | PD | 60 | mSD | 82 | 144 | Decrease of peripheral blasts | + | − | + | + |
10 | 59 | M4 | Normal | 2× ind. reind. autoPBSCT | 3. PR | 2 | 4 | 5–10 | PD | 29 | PD | − | 29 | − | na | na | na | na |
11 | 65 | M4 | Normal | Ind. | PD | 2 | 12 | 10 | SD | 134 | SD | − | 134 | − | − | − | − | − |
12 | 67 | RAEBII | Normal | None | PD | 2 | 24 | 12 | Major neutrophil response | 112 | mSD | 231 | 339 | − | + | + | + | + |
13 | 61 | WHO II | Normal | None | PD | 2 | 11 | 60 | SD | 142 | SD | − | 142 | − | − | + | − | − |
14 | 69 | RAEB I | Normal | ATG, CsA | PD | 2 | 10 | 10 | Major neutrophil response | 69 | Major neutrophil response | − | 69 | − | − | − | − | − |
15 | 75 | WHO II | Complex | None | PD | 2 | 10 | 60 | SD | 132 | SD | − | 132 | Decrease of marrow blasts (30% at 3 months) | − | − | + | + |
16 | 82 | M4 | Normal | None | PD | 2 | 11 | 50 | PD | 66 | mSD | 112 | 137 | − | + | + | + | |
17 | 65 | M2 | Trisomy 8 | 1× ind. 2× cons. | 1. PR | 2 | 27+ | 5 | SD ongoing | SD ongoing | − | 571 (+) | Erythroid response after 4 months, molecular response with complete disappearance of trisomy 8 | − | + | + | + | |
18 | 58 | M2 | Normal | None | PD | 2 | 23+ | 40 | SD ongoing | 506 (+) | SD ongoing | − | 506 (+) | Decrease of marrow blasts (12% at 3 months) | − | − | − | − |
19 | 69 | WHO II | 46 XX (del5) | Low araC | 1. PR | 2 | 11 | 30 | SD | 168 | SD | 168 | Blast response at 3 months (15%) | − | + | − | + |
ATG indicates antithymocyte globulin; autoPBSCT, autologous peripheral blood stem cell transplantation; con, consolidation chemotherapy; CsA, cyclosporin A; CR, complete remission; cytokine response, intracellular cytokine response as detected by flow cytometry after stimulation with WT1 peptide in percent (%) of CD3+CD8+ T cells, a cytokine response was considered positive if the percentage of WT1 peptide–specific cytokine producing CD3+CD8+ T cells was at least 2-fold the percentage of an HIV control peptide; Ind, induction chemotherapy; low araC, low-dose cytarabin; mPFS, modified progression-free survival (in case progression occurred prior to 6th vaccination, subsequent time was estimated from first vaccination until subsequent progression); na, not available; Patient no., order of inclusion into study; PD, progressive disease; PFS, progression-free survival; PR, partial remission; reind, reinduction chemotherapy; SD, stable disease; Tetramer+ T cells, WT1-specific tetramer-positive T cells in percent (%) of CD3+CD8+ T cells, which were considered positive, if the frequency of tetramer-positive CD3+CD8+ T cells at baseline exceeded 0.3%, which was the mean + 2 SDs (0.16% + 0.14%) observed in 12 healthy control subjects; tetramer response, an increase of at least 2-fold in frequency as compared to baseline was considered as vaccine-induced response; type, AMLs were classified according to the WHO classification (patients belonging to the category ″AMLs not otherwise categorized″ are subclassified according to the old FAB classification): all other patients belonged to the second group of the WHO classification (WHOII = ″AML with multilineage dysplasia- with prior MDS″); and vacc, vaccination.