Table 1.
Demographics, Baseline Disease Characteristics, and Outcomes, by Patient
| Patient | Age (Years) | Sex | Baseline ECOG PS | De Novo vs Secondary AML | Cytogenetic Risk and Age Category | KIR m/m GVL1 | Induction Therapy | No. of Cycles | Duration of CR1 at Treatment | Donor NK Cells (%) Day 72 | RFS (Days)3 | OS (Days)4 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3×105 | ||||||||||||
| 3-001 | 74 | F | 0 | De Novo | Adverse Del(5q) | No | Cytarabine; Daunorubicin liposome (CPX-351) | 1 | 65 | 0 | 92 | 98 |
| 3-002 | 72 | F | 0 | De Novo | Adverse Del (7) | Bw4 C2 | Cytarabine, Daunorubicin | 1 | 71 | 2 | 525 | 525 |
| 8-002 | 73 | F | 1 | Secondary | Adverse Del (5) | Bw4 | Cytarabine, Daunorubicin | 1 | 49 | 0 | 105 | 410 |
| 1×106 | ||||||||||||
| 2-001 | 79 | M | 0 | De Novo | Unknown Age >60 | C2 | Clofarabine, Cytarabine | 1 | 58 | 2 | 1448+5 | 1448+5 |
| 3-004 | 74 | M | 0 | Secondary | Unknown Age >60 | No | 88 | 15 | 117 | 131 | ||
| 3-005 | 76 | F | 1 | Secondary | Unknown Age >60 | C2 | Clofarabine | 1 | 33 | 1 | 156 | 232 |
| 3×106 | ||||||||||||
| 2-002 | 75 | M | 0 | De Novo | Unknown Age >60 | C2 | Cytarabine, Idarubicin | 1 | 28 | 15 | 344 | 347 |
| 3-006 | 67 | M | 0 | Secondary | Unknown Therapy-related AML | No | Cytarabine, Idarubicin | 1 | 139 | 2 | 1292+5 | 1292+5 |
| 5-001 | 57 | M | 1 | De Novo | Intermediate 2 FLT3-ITD mutation w/o NPM1 mutation | No | Cytarabine, Daunorubicin, Idarubicin | 1 | 117 | 0 | 9915 | 9915 |
| 8-004 | 73 | M | 0 | De Novo | Unknown Age >60 | Bw4 C2 | Cytarabine, Daunorubicin | 1 | 89 | 84 | 183 | 241 |
| 8-005 | 66 | M | 1 | Secondary | 8% blasts; MDS phenotype; 5.9% MRD Age >60 | Bw4 | – | – | – | 11 | 176 | 176 |
| 8-006 | 66 | M | 2 | De Novo | Age >60 | No | Cytarabine, Daunorubicin | 1 | 167 | 64 | 330 | 336 |
CR1=First complete remission; ECOG=Eastern Cooperative Oncology Group; F=Female; M=Male; NK=Natural killer; PS=Performance status; OS=Survival; RFS=Relapse-free survival. Cytogenetic risk category was defined as described.27
Donor and recipient HLA were used to identify KIR ligand mismatch in the graft versus leukemia (GVL) direction. The mismatched allele or if there was no mismatch is indicated.
Donor NK cells (%), as detected by molecular DNA chimerism with STR genotyping.
Relapse free survival from CR1 was defined as the time from the date of CR1 until the date of relapse or death due to any cause. For relapse free survival from CR1, if patients died without documented relapse, they were considered to have relapsed on the day of their death. If patients did not progress through 12 months of follow-up or were lost to follow-up before the 12-month follow-up visit, they were censored at the day of last disease status assessment.
Overall Survival from CR1 was defined as the time from the date of CR1 until the date of death from any cause. For OS durations, if the patient was alive at the end of the follow-up period or was lost to follow-up, OS duration from CR1 was censored on the last date the patient was known to be alive.
Based on post-trial follow-up.