Clinical characteristics: Patient demographics, status at study entry, response, and toxicity
| Patient no. . | 1 . | 2 . | 3 . | 4 . | 5 . | 6 . | 7 . | 8 . | 9 . | 10 . | 11 . | 12 . | 13 . | 14 . | 15 . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Demographics | |||||||||||||||
| Age, y | 21 | 31 | 1 | 13 | 9 | 29 | 15 | 43 | 29 | 20 | 7 | 60 | 11 | 34 | 32 |
| Sex | M | M | M | F | F | M | M | M | F | F | M | M | F | M | F |
| Diagnosis | NHL | AML | Imm | ALL | MDS | NHL | ALL | CML | ALL | NHL | ALL | NHL | AA | CML | MDS |
| HLA match | 6/6 | 5/6 | 6/6 | 6/6 | 6/6 | 5/6 | 6/6 | 6/6 | 6/6 | 6/6 | 6/6 | 6/6 | 6/6 | 5/6 | 6/6 |
| Donor type | MRD | URD | URD | URD | URD | URD | URD | URD | URD | URD | URD | URD | URD | URD | MRD |
| Donor cells | PSC | PSC | Cord | BM | BM | BM | BM | PSC | PSC | PSC | BM | PSC | BM | BM | PSC |
| Conditioning | CBV | MTBI | BuCy | CyTBI | BuCy | CBV | BAC | CyTBI | CyTBI | CVB | CyTBI | BuFl | CyTLI | BuCy | CyTBI |
| Status at study entry | |||||||||||||||
| Acute GVHD | Yes | Yes | Yes | Yes | Yes | No | Yes | No | No | No | Yes | No | No | Yes | Yes |
| Prior steroids, d | 4 | 1 | 28 | 3 | 0 | 9 | 2 | 0 | 2 | 8 | 2 | 2 | 0 | 7 | 3 |
| Prior O2, d | 2 | 4 | 3 | 1 | 1 | 12 | 2 | 2 | 3 | 5 | 3 | 6 | 3 | 7 | 1 |
| IPS onset, date | +19 | +10 | +56 | +12 | +12 | +9 | +11 | +15 | +13 | +13 | +14 | +83 | +17 | +87 | +19 |
| Initiation study treatment | +23 | +11 | +58 | +13 | +13 | +15 | +12 | +17 | +16 | +21 | +16 | +87 | +20 | +94 | +20 |
| Intubated (at entry) | Yes | Yes | No | No | No | Yes | No | No | Yes | Yes | No | Yes | No | No | Yes |
| Response | |||||||||||||||
| Clinical response | CR | CR | CR | CR | CR | NR | CR | CR | NR | NR | NR | NR | CR | CR | CR |
| Total doses until CR | 3 | 5 | 2 | 2 | 1 | NA | 2 | 5 | NA | NA | NA | NA | 3 | 2 | 1 |
| No. days until off O2 | 8 | 17 | 5 | 4 | 3 | NA | 5 | 16 | NA | NA | NA | NA | 10 | 4 | 17 |
| Overall survival | 148 | 233 | 199 | 238 | +1425 | 7 | +1344 | 67 | 17 | 18 | 55 | 4 | 46 | 62 | +705 |
| Cause of death | Rel | GVH | CF | GVH | — | IPS | — | INF | IPS | IPS | IPS | IPS | INF | INF | — |
| Toxicity: infections | — | — | — | — | — | Bact | — | Bact | — | — | — | Bact | CMV | Fungal | — |
| Patient no. . | 1 . | 2 . | 3 . | 4 . | 5 . | 6 . | 7 . | 8 . | 9 . | 10 . | 11 . | 12 . | 13 . | 14 . | 15 . |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Demographics | |||||||||||||||
| Age, y | 21 | 31 | 1 | 13 | 9 | 29 | 15 | 43 | 29 | 20 | 7 | 60 | 11 | 34 | 32 |
| Sex | M | M | M | F | F | M | M | M | F | F | M | M | F | M | F |
| Diagnosis | NHL | AML | Imm | ALL | MDS | NHL | ALL | CML | ALL | NHL | ALL | NHL | AA | CML | MDS |
| HLA match | 6/6 | 5/6 | 6/6 | 6/6 | 6/6 | 5/6 | 6/6 | 6/6 | 6/6 | 6/6 | 6/6 | 6/6 | 6/6 | 5/6 | 6/6 |
| Donor type | MRD | URD | URD | URD | URD | URD | URD | URD | URD | URD | URD | URD | URD | URD | MRD |
| Donor cells | PSC | PSC | Cord | BM | BM | BM | BM | PSC | PSC | PSC | BM | PSC | BM | BM | PSC |
| Conditioning | CBV | MTBI | BuCy | CyTBI | BuCy | CBV | BAC | CyTBI | CyTBI | CVB | CyTBI | BuFl | CyTLI | BuCy | CyTBI |
| Status at study entry | |||||||||||||||
| Acute GVHD | Yes | Yes | Yes | Yes | Yes | No | Yes | No | No | No | Yes | No | No | Yes | Yes |
| Prior steroids, d | 4 | 1 | 28 | 3 | 0 | 9 | 2 | 0 | 2 | 8 | 2 | 2 | 0 | 7 | 3 |
| Prior O2, d | 2 | 4 | 3 | 1 | 1 | 12 | 2 | 2 | 3 | 5 | 3 | 6 | 3 | 7 | 1 |
| IPS onset, date | +19 | +10 | +56 | +12 | +12 | +9 | +11 | +15 | +13 | +13 | +14 | +83 | +17 | +87 | +19 |
| Initiation study treatment | +23 | +11 | +58 | +13 | +13 | +15 | +12 | +17 | +16 | +21 | +16 | +87 | +20 | +94 | +20 |
| Intubated (at entry) | Yes | Yes | No | No | No | Yes | No | No | Yes | Yes | No | Yes | No | No | Yes |
| Response | |||||||||||||||
| Clinical response | CR | CR | CR | CR | CR | NR | CR | CR | NR | NR | NR | NR | CR | CR | CR |
| Total doses until CR | 3 | 5 | 2 | 2 | 1 | NA | 2 | 5 | NA | NA | NA | NA | 3 | 2 | 1 |
| No. days until off O2 | 8 | 17 | 5 | 4 | 3 | NA | 5 | 16 | NA | NA | NA | NA | 10 | 4 | 17 |
| Overall survival | 148 | 233 | 199 | 238 | +1425 | 7 | +1344 | 67 | 17 | 18 | 55 | 4 | 46 | 62 | +705 |
| Cause of death | Rel | GVH | CF | GVH | — | IPS | — | INF | IPS | IPS | IPS | IPS | INF | INF | — |
| Toxicity: infections | — | — | — | — | — | Bact | — | Bact | — | — | — | Bact | CMV | Fungal | — |
NHL indicates non-Hodgkin lymphoma; AML, acute myelogenous leukemia; Imm, congenital immune disorder; ALL, acute lymphoblastic leukemia; CML, chronic myelogenous leukemia; MDS, myelodysplastic syndrome; URD, unrelated donor; MRD, matched related donor; BM, bone marrow; PSC, peripheral stem cells; Prior steroids, number of days that a patient was on corticosteroids prior to study entry; Prior O2, number of days that a patient required supplemental oxygen support prior to study entry; CBV, cyclophosphamide, busulfan, VP16; MTBI, melphalan, total body irradiation; BuCy, busulfan, cyclophosphamide; BuFlu, busulfan, fludarabine; CyTLI, cyclophosphamide, total lymphoid irradiation; CR, complete response; NR, nonresponder; Rel, relapsed malignancy; CF, cardiac failure; INF, infection; Bact, bacteremia; and —, not applicable.