Patient and graft characteristics
. | . | . | . | . | . | . | CPM, no. . | . | . | . | . | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient no. (age, y) . | Diagnosis . | Conditioning . | Dose level, per kg . | No. CD34/kg . | No. CD3/kg . | % CD3+/CD25+ . | No IT . | IT . | % residual proliferation . | Alemtuzumab level at first infusion, ng/mL . | No. infusions . | |
| P1 (8) | Rel ALL in second CR | Cy/TBI/Ara-C/alemtuzumab | 104 | 1.4 × 107 | 1.8 × 104 | 0.15 | 4 014 | 765 | 0 | 1180 | 3 | |
| P2 (14) | Ref AML | Cy/TBI/Ara-C/alemtuzumab | 104 | 1.2 × 107 | 0.7 × 104 | 0.27 | 21 033 | 1006 | 0.46 | Undetectable | 1 (GVH) | |
| P3 (3) | Rel ALL on Rx in second CR | Cy/TBI/Ara-C/alemtuzumab | 104 | 1.1 × 107 | 3.4 × 104 | 0.03 | 1 770 | 510 | 0 | Undetectable | 3 | |
| P4 (3) | AML first CR | Cy/TBI/Ara-C/alemtuzumab | 104 | 6.3 × 106 | 1 × 105 | 0.1 | 41 980 | 578 | 0.71 | Undetectable | 3 | |
| P5 (12) | Ref AML | Cy/TBI/Ara-C/alemtuzumab | 104 | 7.5 × 106 | 3.4 × 104 | 0.02 | 20 633 | 1071 | 1.00 | NE | 3 | |
| P6 (28) | Hodgkins in relapse after ABMT | TBI/FDR/alemtuzumab | 104 | 6.9 × 106 | 2.2 × 104 | 0.01 | 28 256 | 866 | 0.33 | 350 | 3 | |
| P7 (3) | HLH | Cy/TBI/Ara-C/alemtuzumab | 104 | 2.0 × 107 | 4.4 × 104 | 0.07 | 14 068 | 601 | 3.12 | NE | 3 | |
| P8 (58) | CML LBC in 2nd CP | TBI/FDR/alemtuzumab | 104 | 1.3 × 107 | 2.6 × 104 | 0.11 | 4 160 | 367 | 0 | 303 | 1 (autologous reconstitution) | |
| P9 (2) | Rel AML after MMUD BMT in relapse | TBI/FDR/alemtuzumab | 105 | 1.2 × 107 | 1.3 × 104 | 0.11 | 2 569 | 513 | 0 | Undetectable | 1 (CD3 > 1000) | |
| P10 (2) | Ref AML | Cy/TBI/Ara-C/alemtuzumab | 105 | 1.8 × 107 | 1.8 × 105 | 0.19 | 22 252 | 1423 | 0.04 | Undetectable | 2 (CD3 > 1000) | |
| P11 (8) | HLH | Cy/TBI/Ara-C/alemtuzumab | 105 | 1.4 × 107 | 2.4 × 104 | 0.13 | 72 204 | 1366 | 1.18 | 426 | 3 | |
| P12 (12) | SAA | FDR/Cy/TBI/alemtuzumab | 105 | 5.9 × 106 | 0.9 × 104 | 0.05 | 2 103 | 1369 | 0 | NE | 2 (GVH) | |
| P13 (14) | MDS | FDR/Cy/TBI/ATG | 105 | 7.5 × 106 | 2.7 × 104 | 0.01 | 4 695 | 340 | 2.80 | — | 4 | |
| P14 (6) | JMML/AML after haplo-SCT in third CR | FLAG | 105 | 1.1 × 107 | 2.1 × 104 | 0.03 | 21 719 | 1346 | 0.57 | — | 4 | |
| P15 (10) | Fanconi, rejected first haplo-SCT | FDR/Cy/TBI/ATG | 105 | 2 × 107 | 1 × 105 | 0.25 | 6 879 | 717 | 0 | — | 3 | |
| P16 (14) | Rel AML after syngeneic BMT in relapse | TBI/FDR/alemtuzumab | 105 | 1.1 × 107 | 6.4 × 104 | 0.12 | 39 801 | 604 | 0 | Undetectable | 3 | |
. | . | . | . | . | . | . | CPM, no. . | . | . | . | . | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient no. (age, y) . | Diagnosis . | Conditioning . | Dose level, per kg . | No. CD34/kg . | No. CD3/kg . | % CD3+/CD25+ . | No IT . | IT . | % residual proliferation . | Alemtuzumab level at first infusion, ng/mL . | No. infusions . | |
| P1 (8) | Rel ALL in second CR | Cy/TBI/Ara-C/alemtuzumab | 104 | 1.4 × 107 | 1.8 × 104 | 0.15 | 4 014 | 765 | 0 | 1180 | 3 | |
| P2 (14) | Ref AML | Cy/TBI/Ara-C/alemtuzumab | 104 | 1.2 × 107 | 0.7 × 104 | 0.27 | 21 033 | 1006 | 0.46 | Undetectable | 1 (GVH) | |
| P3 (3) | Rel ALL on Rx in second CR | Cy/TBI/Ara-C/alemtuzumab | 104 | 1.1 × 107 | 3.4 × 104 | 0.03 | 1 770 | 510 | 0 | Undetectable | 3 | |
| P4 (3) | AML first CR | Cy/TBI/Ara-C/alemtuzumab | 104 | 6.3 × 106 | 1 × 105 | 0.1 | 41 980 | 578 | 0.71 | Undetectable | 3 | |
| P5 (12) | Ref AML | Cy/TBI/Ara-C/alemtuzumab | 104 | 7.5 × 106 | 3.4 × 104 | 0.02 | 20 633 | 1071 | 1.00 | NE | 3 | |
| P6 (28) | Hodgkins in relapse after ABMT | TBI/FDR/alemtuzumab | 104 | 6.9 × 106 | 2.2 × 104 | 0.01 | 28 256 | 866 | 0.33 | 350 | 3 | |
| P7 (3) | HLH | Cy/TBI/Ara-C/alemtuzumab | 104 | 2.0 × 107 | 4.4 × 104 | 0.07 | 14 068 | 601 | 3.12 | NE | 3 | |
| P8 (58) | CML LBC in 2nd CP | TBI/FDR/alemtuzumab | 104 | 1.3 × 107 | 2.6 × 104 | 0.11 | 4 160 | 367 | 0 | 303 | 1 (autologous reconstitution) | |
| P9 (2) | Rel AML after MMUD BMT in relapse | TBI/FDR/alemtuzumab | 105 | 1.2 × 107 | 1.3 × 104 | 0.11 | 2 569 | 513 | 0 | Undetectable | 1 (CD3 > 1000) | |
| P10 (2) | Ref AML | Cy/TBI/Ara-C/alemtuzumab | 105 | 1.8 × 107 | 1.8 × 105 | 0.19 | 22 252 | 1423 | 0.04 | Undetectable | 2 (CD3 > 1000) | |
| P11 (8) | HLH | Cy/TBI/Ara-C/alemtuzumab | 105 | 1.4 × 107 | 2.4 × 104 | 0.13 | 72 204 | 1366 | 1.18 | 426 | 3 | |
| P12 (12) | SAA | FDR/Cy/TBI/alemtuzumab | 105 | 5.9 × 106 | 0.9 × 104 | 0.05 | 2 103 | 1369 | 0 | NE | 2 (GVH) | |
| P13 (14) | MDS | FDR/Cy/TBI/ATG | 105 | 7.5 × 106 | 2.7 × 104 | 0.01 | 4 695 | 340 | 2.80 | — | 4 | |
| P14 (6) | JMML/AML after haplo-SCT in third CR | FLAG | 105 | 1.1 × 107 | 2.1 × 104 | 0.03 | 21 719 | 1346 | 0.57 | — | 4 | |
| P15 (10) | Fanconi, rejected first haplo-SCT | FDR/Cy/TBI/ATG | 105 | 2 × 107 | 1 × 105 | 0.25 | 6 879 | 717 | 0 | — | 3 | |
| P16 (14) | Rel AML after syngeneic BMT in relapse | TBI/FDR/alemtuzumab | 105 | 1.1 × 107 | 6.4 × 104 | 0.12 | 39 801 | 604 | 0 | Undetectable | 3 | |
Rel indicates relapsed; ref, refractory; CR, complete remission; HLH, hemophagocytic lymphohistiocytosis; LBC, lymphoid blast crisis; MMUD, mismatched unrelated donor; SAA, severe aplastic anemia; MDS, myelodysplasia; Cy, cyclophosphamide; TBI, total body irradiation; Ara-C, cytarabine; ATG, rabbit antithymocyte globulin; FLAG, fludarabine/cytarabine/G-CSF; CPM, counts per minute in primary mixed lymphocyte reaction of day-4 donor PBMCs + host LCLs with and without immunotoxin (IT); % Resid prol, shows residual proliferation calculated as outlined in “Patients, materials, and methods'; NE, not evaluated; and —, not given alemtuzumab.