Chimerism, GVHD, infection, and clinical outcome
Dose level and patient no. . | % donor at 6 mo . | aGVHD . | cGVHD . | Viral reactivations . | Fungal infection . | Autoimmunity . | Off study, mo after SCT . | Current status* . |
|---|---|---|---|---|---|---|---|---|
| Dose level 1 | ||||||||
| P1 | 100 | None | None | CMV/VZV | None | None | — | Alive in CR |
| P2 | 100 | Grade 4 skin | Ext (skin/liver) | CMV/Adeno | Aspergillus (B/C) | None | 8, death from liver failure | Death from liver failure (adeno/GVH) |
| P3 | 57 MNCs, 56 grans | None | None | CMV | None | None | 8, 2nd SCT for mixed chimerism | Alive in CR after 2nd SCT |
| P4 | 97 | None | None | None | None | None | 6, relapse | Death from disease/infection/hemorrhage |
| P5 | Relapsed | None | None | None | None | None | 5, relapse | Death from disease |
| P6 | 100 | None | None | CMV/VZV/EBV | None | None | 9, relapse | Death from disease/infection |
| P7 | 74 MNCs, 66 grans | None | None | CMV/EBV | None | None | 5, autologous reconstitution/relapse | Death from disease/infection |
| P8 | 0 MNCs, 0 grans | None | Not evaluable | CMV | None | None | 3, autologous reconstitution | Alive in CR after 2nd SCT |
| Dose level 2 | ||||||||
| P9 | 100 | Grade 1 skin | None | EBV | None | None | 8, relapse | Alive in relapse |
| P10 | Relapsed | None | None | CMV | None | None | 5, death from respiratory failure | Death from interstitial pneumonitis |
| P11 | 100 | Grade 1 gut | None | EBV | None | None | — | Alive in CR |
| P12 | 100 | Grade 2 skin | Ext (skin/mouth) | EBV | None | None | — | Alive in CR |
| P13 | 100 | None | None | CMV/EBV/JC | Pulmonary | AIHA | 30, death from multiorgan failure | Death from sepsis + multiorgan failure |
| P14 | 100 | None | None | None | None | None | 7, relapse | Death from disease |
| P15 | 100 | None | None | CMV/Adeno | Pulmonary | None | 7, death from encephalopathy | Death from postinfective encephalopathy |
| P16 | 100 | None | None | None | None | None | 8, relapse | Alive in relapse |
Dose level and patient no. . | % donor at 6 mo . | aGVHD . | cGVHD . | Viral reactivations . | Fungal infection . | Autoimmunity . | Off study, mo after SCT . | Current status* . |
|---|---|---|---|---|---|---|---|---|
| Dose level 1 | ||||||||
| P1 | 100 | None | None | CMV/VZV | None | None | — | Alive in CR |
| P2 | 100 | Grade 4 skin | Ext (skin/liver) | CMV/Adeno | Aspergillus (B/C) | None | 8, death from liver failure | Death from liver failure (adeno/GVH) |
| P3 | 57 MNCs, 56 grans | None | None | CMV | None | None | 8, 2nd SCT for mixed chimerism | Alive in CR after 2nd SCT |
| P4 | 97 | None | None | None | None | None | 6, relapse | Death from disease/infection/hemorrhage |
| P5 | Relapsed | None | None | None | None | None | 5, relapse | Death from disease |
| P6 | 100 | None | None | CMV/VZV/EBV | None | None | 9, relapse | Death from disease/infection |
| P7 | 74 MNCs, 66 grans | None | None | CMV/EBV | None | None | 5, autologous reconstitution/relapse | Death from disease/infection |
| P8 | 0 MNCs, 0 grans | None | Not evaluable | CMV | None | None | 3, autologous reconstitution | Alive in CR after 2nd SCT |
| Dose level 2 | ||||||||
| P9 | 100 | Grade 1 skin | None | EBV | None | None | 8, relapse | Alive in relapse |
| P10 | Relapsed | None | None | CMV | None | None | 5, death from respiratory failure | Death from interstitial pneumonitis |
| P11 | 100 | Grade 1 gut | None | EBV | None | None | — | Alive in CR |
| P12 | 100 | Grade 2 skin | Ext (skin/mouth) | EBV | None | None | — | Alive in CR |
| P13 | 100 | None | None | CMV/EBV/JC | Pulmonary | AIHA | 30, death from multiorgan failure | Death from sepsis + multiorgan failure |
| P14 | 100 | None | None | None | None | None | 7, relapse | Death from disease |
| P15 | 100 | None | None | CMV/Adeno | Pulmonary | None | 7, death from encephalopathy | Death from postinfective encephalopathy |
| P16 | 100 | None | None | None | None | None | 8, relapse | Alive in relapse |
MNCs indicates mononuclear cells; grans, granulocytes; B/C, blood cultures; and —, completed study.
As of June 2006.