Presenting features of the patients and clinical outcome
Patient/dosage* . | Age, y . | Sex . | Disease status at collection of blasts . | Treatment prior to immunization† . | Conditioning regimen or chemotherapy . | GvHD prophylaxis . | Time from last treatment to first injection, d . | Time from cessation of immunosuppression to first injection, d . | Remission status prior to first injection . | Time to relapse, d . | Current status/survival from first injection, d . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1/1 | 18 | M | Relapsed B ALL (L3) | MUD BMT (6/6) | TBI + Cyclo + AraC | CSA, MTX | 119 | 52 | PR2 | 27 | DOD/33 |
| 2/1 | 4 | M | Relapsed AML (M4) with t(10;11) | MUD BMT (6/6) | TBI + ATG + Cyclo + AraC | CSA, MTX | 130 | 37 | CR2 | NA | NED/1847 |
| 3/1 | 39 | F | Relapsed pre-B ALL with del 12p | MRD BMT (6/6) | TBI + ATG + fludarabine | FK506 | 320 | 116 | CR2 | 150 | NED/1518 |
| 4/1 | 12 | F | Relapsed pre-B ALL | MUD BMT (6/6) | TBI + ATG + Cyclo + AraC | CSA | 321 | 195 | CR2 | NA | NED/1495 |
| 5/2 | 12 | M | Relapsed pre-B ALL | MRD BMT (6/6) | TBI + Cyclo + AraC | CSA, MTX | 348 | 105 | CR2 | NA | NED/1377 |
| 6/2 | 5 | M | Pre-B ALL with t(9;22) | MMUD BMT (5/6) | TBI + ATG + Cyclo + AraC | CSA, FK506 | 609 | 14 | CR1 | NA | NED/1229 |
| 7/2 | 13 | M | Relapsed pre-B ALL (testis) | Chemotherapy | Individualized relapse protocol | — | 29 | 29 | CR2 | NA | NED/1152 |
| 8/3 | 46 | M | MDS/AML (M6) with t(6;9) | MRD BMT (6/6) | TBI + Cyclo | FK506, MTX | 217 | 35 | CR1 | NA | NED/984 |
| 9/3 | 18 | M | Secondary AML (M0) with del 7 | MRD BMT (6/6) | TBI + alemtuzumab + Cyclo + AraC | FK506, MTX | 139 | 10 | CR1 | NA | NED/949 |
| 10/3 | 54 | F | Relapsed AML (M2) | MRD BMT (6/6) | TBI + alemtuzumab + fludarabine | FK506 | 167 | 112 | CR2 | NA | NED/811 |
Patient/dosage* . | Age, y . | Sex . | Disease status at collection of blasts . | Treatment prior to immunization† . | Conditioning regimen or chemotherapy . | GvHD prophylaxis . | Time from last treatment to first injection, d . | Time from cessation of immunosuppression to first injection, d . | Remission status prior to first injection . | Time to relapse, d . | Current status/survival from first injection, d . |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1/1 | 18 | M | Relapsed B ALL (L3) | MUD BMT (6/6) | TBI + Cyclo + AraC | CSA, MTX | 119 | 52 | PR2 | 27 | DOD/33 |
| 2/1 | 4 | M | Relapsed AML (M4) with t(10;11) | MUD BMT (6/6) | TBI + ATG + Cyclo + AraC | CSA, MTX | 130 | 37 | CR2 | NA | NED/1847 |
| 3/1 | 39 | F | Relapsed pre-B ALL with del 12p | MRD BMT (6/6) | TBI + ATG + fludarabine | FK506 | 320 | 116 | CR2 | 150 | NED/1518 |
| 4/1 | 12 | F | Relapsed pre-B ALL | MUD BMT (6/6) | TBI + ATG + Cyclo + AraC | CSA | 321 | 195 | CR2 | NA | NED/1495 |
| 5/2 | 12 | M | Relapsed pre-B ALL | MRD BMT (6/6) | TBI + Cyclo + AraC | CSA, MTX | 348 | 105 | CR2 | NA | NED/1377 |
| 6/2 | 5 | M | Pre-B ALL with t(9;22) | MMUD BMT (5/6) | TBI + ATG + Cyclo + AraC | CSA, FK506 | 609 | 14 | CR1 | NA | NED/1229 |
| 7/2 | 13 | M | Relapsed pre-B ALL (testis) | Chemotherapy | Individualized relapse protocol | — | 29 | 29 | CR2 | NA | NED/1152 |
| 8/3 | 46 | M | MDS/AML (M6) with t(6;9) | MRD BMT (6/6) | TBI + Cyclo | FK506, MTX | 217 | 35 | CR1 | NA | NED/984 |
| 9/3 | 18 | M | Secondary AML (M0) with del 7 | MRD BMT (6/6) | TBI + alemtuzumab + Cyclo + AraC | FK506, MTX | 139 | 10 | CR1 | NA | NED/949 |
| 10/3 | 54 | F | Relapsed AML (M2) | MRD BMT (6/6) | TBI + alemtuzumab + fludarabine | FK506 | 167 | 112 | CR2 | NA | NED/811 |
GvHD indicates graft-versus-host disease; ALL, acute lymphoblastic leukemia; MUD, matched-unrelated donor; BMT, bone marrow transplantation; TBI, total-body irradiation; Cyclo, cyclophosphamide; AraC, cytarabine; CSA, cyclosporin-A; MTX, methotrexate; PR, partial remission; DOD, died of disease; AML, acute myeloid leukemia; t, translocation; ATG, antithymocyte globulin; CR, complete remission; NED, no evidence of disease; del, deletion; MRD, matched-related donor; MMUD, mismatched-unrelated donor; MDS, myelodysplastic syndrome; and NA, not applicable.
The dose-escalation schedule began at 2 × 105 CD40L-secreting skin fibroblasts per injection (dose level 1), increasing in log increments to 2 × 107 (dose level 3). IL-2-secreting skin fibroblasts and recipient-derived blasts were administered at a fixed dosage throughout the study (2 × 107 per injection)
The numbers in parentheses indicate the number of matches out of 6