Patient characteristics
No. treated | 30 |
| Median age, y (range) | 43 (20-63) |
| Sex, M/F | 15/15 |
| Diagnosis, no. | |
| Acute leukemia/myelodysplastic syndrome | 15 |
| CML/chronic myeloproliferative disorder | 4 |
| Chronic lymphocytic leukemia | 6 |
| Non-Hodgkin lymphoma | 3 |
| Hodgkin lymphoma | 1 |
| Plasma cell leukemia | 1 |
| Donor, no. | |
| Matched related | 2 |
| Matched unrelated | 26 |
| Antigen mismatched related | 1 |
| Antigen mismatched unrelated | 1 |
| Stem cell source, no. | |
| Marrow | 6 |
| PBSCs | 24 |
| Conditioning, no. | |
| Cy/TBI | 17 |
| Bu/Cy | 2 |
| Fly/Bu (nonmyeloablative) | 11 |
| GVHD prophylaxis, no. | |
| FK506/MTX | 10 |
| FK506/mini-MTX/CD8+ T-cell depletion | 8 |
| FK506/mini-MTX/sirolimus | 3 |
| FK506/prednisone | 1 |
| CyA/prednisone | 3 |
| CyA/prednisone/MMF | 5 |
| Prior GVHD therapy (within 3 wk of enrollment), no. | |
| Tacrolimus | 23 |
| Cyclosporine | 7 |
| Sirolimus | 8 |
| MMF | 16 |
| Daclizumab | 12 |
| Infliximab | 3 |
| Extracorporeal photopheresis | 1 |
| Median no. of prior immunosuppressive agents (range) | 3 (2-6) |
| Acute GVHD grade at enrollment, no. | |
| II | 11 |
| III | 13 |
| IV | 6 |
| Denileukin diftitox dose level | |
| 9 μg/kg d 1, 15 | 7 |
| 9 μg/kg d 1, 3, 5, 15, 17, 19 | 18* |
| 9 μg/kg d 1-5, 16-19 | 5 |
No. treated | 30 |
| Median age, y (range) | 43 (20-63) |
| Sex, M/F | 15/15 |
| Diagnosis, no. | |
| Acute leukemia/myelodysplastic syndrome | 15 |
| CML/chronic myeloproliferative disorder | 4 |
| Chronic lymphocytic leukemia | 6 |
| Non-Hodgkin lymphoma | 3 |
| Hodgkin lymphoma | 1 |
| Plasma cell leukemia | 1 |
| Donor, no. | |
| Matched related | 2 |
| Matched unrelated | 26 |
| Antigen mismatched related | 1 |
| Antigen mismatched unrelated | 1 |
| Stem cell source, no. | |
| Marrow | 6 |
| PBSCs | 24 |
| Conditioning, no. | |
| Cy/TBI | 17 |
| Bu/Cy | 2 |
| Fly/Bu (nonmyeloablative) | 11 |
| GVHD prophylaxis, no. | |
| FK506/MTX | 10 |
| FK506/mini-MTX/CD8+ T-cell depletion | 8 |
| FK506/mini-MTX/sirolimus | 3 |
| FK506/prednisone | 1 |
| CyA/prednisone | 3 |
| CyA/prednisone/MMF | 5 |
| Prior GVHD therapy (within 3 wk of enrollment), no. | |
| Tacrolimus | 23 |
| Cyclosporine | 7 |
| Sirolimus | 8 |
| MMF | 16 |
| Daclizumab | 12 |
| Infliximab | 3 |
| Extracorporeal photopheresis | 1 |
| Median no. of prior immunosuppressive agents (range) | 3 (2-6) |
| Acute GVHD grade at enrollment, no. | |
| II | 11 |
| III | 13 |
| IV | 6 |
| Denileukin diftitox dose level | |
| 9 μg/kg d 1, 15 | 7 |
| 9 μg/kg d 1, 3, 5, 15, 17, 19 | 18* |
| 9 μg/kg d 1-5, 16-19 | 5 |
CML. indicates chronic myelogenous leukemia; PBSCs, peripheral blood stem cells; Cy/TBI, cyclophosphamide/total body irradiation; Bu/Cy, busulfan/cyclophosphamide; Flu/Bu, fludarabine/busulfex; FK506/MTX, tacrolimus/methotrexate; pred, prednisolone; CyA, cyclosporine A; MMF, mycophenolate mofetil.
Eight patients treated in dose-escalation phase, 10 on MTD expansion phase of trial.