Table 1

Patient characteristics and percentage of tumor-specific CD8+ T cells detected in PBMCs of RICAZA trial patients

PINAge, y/sexDiagnosisPrevious treatmentDisease status at SCTGenetic risk*Donor typeAcute GVHD (grade ≥ 2)Tumor-specific CD8+ T-cell response, % lymphocytes
AntigenStatus at last follow-up
Cycle 1 before txCycle 3Cycle 6Cycle 9
1 54/M AML ADE, MACE, HD ara-C First remission Intermediate MUD No 0 0 1.4 0 BAGE-12-10, MAGE-A2157-166, MAGE-3112-120, MAGE-C2336-344, RAGE-132-40 CR (21 mo after SCT) 
2 63/M AML DA × 2, FLAG × 1 First remission Poor MUD No 0     Relapsed after cycle 1 
3 52/M AML ADE, FLAG + IDA, HD cytarabine First remission Intermediate MRD No 0 0.04 0.03 0.042 MAGE-A2157-166, MAGE-3112-120 CR (15 mo after SCT); DLI administered (13 mo after SCT) 
4 62/M AML DA First remission Intermediate MUD Yes (grade 2) 0 0 0 0.21 MAGE-A1161-169/MAGE-A1289-298 Relapsed after cycle 10 and died 
5 55/F AML with multilineage dysplasia after MDS DA First remission Intermediate MRD No 0.1 0.13 0.025 0.02 MAGE-A2157-166/MAGE-C2336-344/RAGE-1352-360 CR (18 mo after SCT) 
6 58/F AML DA + Mylotarg × 2, FLAG-IDA First remission Poor MRD No 0 0    Relapsed after cycle 3 
7 71/M AML DA × 3, sodium valproate + AZA Second remission Intermediate MUD No 0 0 0 0.1 MAGE-A1161-169/MAGE-A3167-176/BAGE-12-10/MAGE-A3168-176 CR (15 mo after SCT) 
8 64/M AML with multilineage dysplasia DCLo First remission Poor MRD No 0 0 0   Relapsed after cycle 6 
9 70/M AML with multilineage dysplasia DA, FLAG Second remission Poor MUD Yes (grade 2) 0 0 0   Withdrawn after cycle 9 
10 58/M AML ADE + Mylotarg, ADE First remission Poor MRD No 0     Withdrawn after cycle 1 
11 63/M AML DA, FLAG Second remission Intermediate MUD No ND 0 0.42  MAGE-A1289-298/MAGE-A1161-169/MAGE-A3168-176 Withdrawn after cycle 8; DLI administered (8 mo after SCT) 
12 67/F AML with multilineage dysplasia after MDS RCVP. DAT 3 + 10 First relapse Intermediate MUD No 0 ND 0.2 0.11 MAGE-A2212-220 CR (12 mo after SCT) 
13 66/F AML Daunorubicin, clofarabine, Mylotarg, FLAG/IDA Second remission Intermediate MUD No 0 0    Relapsed after cycle 4 and died 
14 58/F Secondary AML in association with previous Jak2+ myelofibrosis ADE, Mylotarg, ADE, DA, Clo First remission Intermediate MUD No ND 1.6 0.44 0.8 MAGE-A2212-220/MAGE-A3112-120/MAGE-A2157-166/MAGE-A3167-176 CR (12 mo after SCT) 
15 59/M AML after MDS FLAG, DA First remission Intermediate MRD No 0 0.284 0.68 0.45 MAGE-A3168-176 Active treatment after cycle 9 
16 68/M AML DA, FLAG, MACE, FLAG-IDA Second remission Intermediate MUD No ND     Relapsed after cycle 2 
17 48/F AML DA, DA, MIDAC First Remission Intermediate MRD No ND 0 0 0.013 MAGE-A2157-166/MAGE-A1161-169/RAGE-1352-360 Active treatment after cycle 9 
18 51/M AML DA, Etoposide, Clo First remission Intermediate MUD No 0 0 0.9 0.09 MAGE-A3112-120/MAGE- C2336-344/WT-1317-327 Active treatment after cycle 6 
19 54/F AML DA × 2, HD araC First remission Intermediate MRD No 0 0.01   MAGE-A3112-120 Relapsed after cycle 5 
20 63/M AML MIDAC × 4 Second remission Intermediate MUD No 0 0 1.36  MAGE-C2336-344/WT-1235-243/MAGE-A3112-120/MAGE-A397-105 Active treatment after cycle 7 
21 60/M AML with multilineage dysplasia DA, Mylotarg, DCLo First remission Intermediate MUD No ND 0 0 0  Active treatment after cycle 5 
22 40/F AML ADE + Mylotarg, DCLo, FLAG-IDA First relapse Intermediate MRD No 0     Active treatment after cycle 4 
23 53/F AML ADE × 2 First remission Intermediate MUD Yes (grade 2) 0 0    Withdrawn after cycle 3 
24 66/M AML MIDAC First remission Intermediate MRD No 0 0.04 0.01 0.17 MAGE-A2157-166/MAGE-A1289-298 Active treatment after cycle 6 
25 55/M Acute myelomonocytic leukemia MIDAC × 4, FLAG-IDA Second remission Intermediate MRD No 0 0 0† 0† MAGE-A397-105/WT-1235-243 Active treatment after cycle 6 
26 62/F Therapy-related AML after previous exposure to a topoisomerase II inhibitor DA × 2, HD araC First remission Poor MUD No 0 0 0   Active treatment after cycle 3 
27 62/M AML after MDS DA × 3, FLAG-IDA, HD araC First remission Intermediate MUD No ND     Active treatment after cycle 3 
PINAge, y/sexDiagnosisPrevious treatmentDisease status at SCTGenetic risk*Donor typeAcute GVHD (grade ≥ 2)Tumor-specific CD8+ T-cell response, % lymphocytes
AntigenStatus at last follow-up
Cycle 1 before txCycle 3Cycle 6Cycle 9
1 54/M AML ADE, MACE, HD ara-C First remission Intermediate MUD No 0 0 1.4 0 BAGE-12-10, MAGE-A2157-166, MAGE-3112-120, MAGE-C2336-344, RAGE-132-40 CR (21 mo after SCT) 
2 63/M AML DA × 2, FLAG × 1 First remission Poor MUD No 0     Relapsed after cycle 1 
3 52/M AML ADE, FLAG + IDA, HD cytarabine First remission Intermediate MRD No 0 0.04 0.03 0.042 MAGE-A2157-166, MAGE-3112-120 CR (15 mo after SCT); DLI administered (13 mo after SCT) 
4 62/M AML DA First remission Intermediate MUD Yes (grade 2) 0 0 0 0.21 MAGE-A1161-169/MAGE-A1289-298 Relapsed after cycle 10 and died 
5 55/F AML with multilineage dysplasia after MDS DA First remission Intermediate MRD No 0.1 0.13 0.025 0.02 MAGE-A2157-166/MAGE-C2336-344/RAGE-1352-360 CR (18 mo after SCT) 
6 58/F AML DA + Mylotarg × 2, FLAG-IDA First remission Poor MRD No 0 0    Relapsed after cycle 3 
7 71/M AML DA × 3, sodium valproate + AZA Second remission Intermediate MUD No 0 0 0 0.1 MAGE-A1161-169/MAGE-A3167-176/BAGE-12-10/MAGE-A3168-176 CR (15 mo after SCT) 
8 64/M AML with multilineage dysplasia DCLo First remission Poor MRD No 0 0 0   Relapsed after cycle 6 
9 70/M AML with multilineage dysplasia DA, FLAG Second remission Poor MUD Yes (grade 2) 0 0 0   Withdrawn after cycle 9 
10 58/M AML ADE + Mylotarg, ADE First remission Poor MRD No 0     Withdrawn after cycle 1 
11 63/M AML DA, FLAG Second remission Intermediate MUD No ND 0 0.42  MAGE-A1289-298/MAGE-A1161-169/MAGE-A3168-176 Withdrawn after cycle 8; DLI administered (8 mo after SCT) 
12 67/F AML with multilineage dysplasia after MDS RCVP. DAT 3 + 10 First relapse Intermediate MUD No 0 ND 0.2 0.11 MAGE-A2212-220 CR (12 mo after SCT) 
13 66/F AML Daunorubicin, clofarabine, Mylotarg, FLAG/IDA Second remission Intermediate MUD No 0 0    Relapsed after cycle 4 and died 
14 58/F Secondary AML in association with previous Jak2+ myelofibrosis ADE, Mylotarg, ADE, DA, Clo First remission Intermediate MUD No ND 1.6 0.44 0.8 MAGE-A2212-220/MAGE-A3112-120/MAGE-A2157-166/MAGE-A3167-176 CR (12 mo after SCT) 
15 59/M AML after MDS FLAG, DA First remission Intermediate MRD No 0 0.284 0.68 0.45 MAGE-A3168-176 Active treatment after cycle 9 
16 68/M AML DA, FLAG, MACE, FLAG-IDA Second remission Intermediate MUD No ND     Relapsed after cycle 2 
17 48/F AML DA, DA, MIDAC First Remission Intermediate MRD No ND 0 0 0.013 MAGE-A2157-166/MAGE-A1161-169/RAGE-1352-360 Active treatment after cycle 9 
18 51/M AML DA, Etoposide, Clo First remission Intermediate MUD No 0 0 0.9 0.09 MAGE-A3112-120/MAGE- C2336-344/WT-1317-327 Active treatment after cycle 6 
19 54/F AML DA × 2, HD araC First remission Intermediate MRD No 0 0.01   MAGE-A3112-120 Relapsed after cycle 5 
20 63/M AML MIDAC × 4 Second remission Intermediate MUD No 0 0 1.36  MAGE-C2336-344/WT-1235-243/MAGE-A3112-120/MAGE-A397-105 Active treatment after cycle 7 
21 60/M AML with multilineage dysplasia DA, Mylotarg, DCLo First remission Intermediate MUD No ND 0 0 0  Active treatment after cycle 5 
22 40/F AML ADE + Mylotarg, DCLo, FLAG-IDA First relapse Intermediate MRD No 0     Active treatment after cycle 4 
23 53/F AML ADE × 2 First remission Intermediate MUD Yes (grade 2) 0 0    Withdrawn after cycle 3 
24 66/M AML MIDAC First remission Intermediate MRD No 0 0.04 0.01 0.17 MAGE-A2157-166/MAGE-A1289-298 Active treatment after cycle 6 
25 55/M Acute myelomonocytic leukemia MIDAC × 4, FLAG-IDA Second remission Intermediate MRD No 0 0 0† 0† MAGE-A397-105/WT-1235-243 Active treatment after cycle 6 
26 62/F Therapy-related AML after previous exposure to a topoisomerase II inhibitor DA × 2, HD araC First remission Poor MUD No 0 0 0   Active treatment after cycle 3 
27 62/M AML after MDS DA × 3, FLAG-IDA, HD araC First remission Intermediate MUD No ND     Active treatment after cycle 3 

ADE indicates cytosine arabinoside/daunorubicin/etoposide; AML, acute myeloid leukemia; BAGE-1, B melanoma Ag 1; CR, complete remission; Clo, clofarabine; DA, daunorubicin/cytosine arabinoside; DAT, daunorubicin,/cytosine arabinoside/6-thioguanine; DClo, daunorubicin/clofarabine; DLI, donor lymphocyte infusion; HD araC, high-dose cytosine arabinoside; FLAG, fludarabine/cytosine arabinoside/GCSF; FLAG-IDA, G-CSF/fludarabine/cytosine arabinoside/idarubicin; MACE, amsacrine/cytosine arabinoside/etoposide; MAGE, melanoma-associated Ag; MDS, myelodysplastic syndrome; MIDAC, mitoxantrone/cytosine arabinoside; MRD, matched related donor; MUD, matched unrelated donor; ND, not done; PB, peripheral blood; PIN, personal identification number; RAGE-1, renal tumor Ag 1; RCVP, rituximab/cyclophosphamide/vincristine/prednisolone; RICAZA, reduced intensity conditioning with azacitidine; SCT, stem cell transplantation; and tx, treatment.

*

Karyotype risk stratification according to Grimwade et al.25 

†

CTA-specific response detected in the BM (cycle 6 = 0.09%) and (cycle 9 = 0.042%) but below detection in PB.

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