Table 1. Transplant characteristics, engraftment and GvHD.
| Campath-20/15 group | Campath-10 group | All | |
|---|---|---|---|
| No. of pts | 19 | 18 | 37 |
| Age, median years (range) | 39 (17–59) | 38 (20–65) | 38 (17–65) |
| Male (M)/female (F) (in %) | 74/26 | 45/55 | 59/40 |
| Disease | |||
| AML | 11 (58%) | 12 (67%) | 23 (62%) |
| De novo/sec-, t-AML | 8/3 | 8/4 | 16/7 |
| CR-1 | 9 | 6 | 15 |
| CR-2 | 0 | 3 | 3 |
| REL/refractory | 2/0 | 0/3 | 5 |
| ALL | 4 (21%) | 6 (33%) | 10 (27%) |
| B-ALL/T-ALL | 3/1 | 5/1 | 8/2 |
| CR-1 | 3a | 5 | 8 |
| CR-2 | 1 | 1 | 2 |
| MDS RAEB-2 (untreated) | 1 (5%) | — | 1 (3%) |
| CML blast crisis, 2nd CP | 1 (5%) | — | 1 (3%) |
| AA/PNH | 2 (10%) | — | 2 (5%) |
| Risk status at HCTb | |||
| Standard/advanced (in %) | 70/30 | 61/39 | 65/35 |
| Stem cell source | |||
| PBSC/BM (in %) | 95/5 | 94/6 | 95/5 |
| Donor | |||
| Sibling | 11 (58%) | 7 (39%) | 18 (49%) |
| VUD | 8 (42%) | 11 (61%) | 19 (51%) |
| 8/8 match | 3 | 6 | 9 |
| 7/8 match | 5 | 5 | 10 |
| Class I mismatch (A/B/C) | −/1/4 | 3/−/2 | 3/1/6 |
| Class II mismatch (DRB1/DQB1/DPB1) | −/−/3 | −/−/6 | −/−/9 |
| Cell dose (median, range) | |||
| CD34+ ( × 106 cells/kg) | 5, 2 (2, 5–15) | 5, 1 (1, 5–10,3) | 5, 2 (1, 5–15) |
| CD3+ ( × 107 cells/kg) | 27 (7–71) | 25 (5–64) | 25 (5–71) |
| Conditioning regimenc | |||
| Busi/Cy | 9 (47%) | 7 (39%) | 16 (43%) |
| TBI/VP16/Cy | 4 (21%) | 4 (22%) | 8 (22%) |
| Flu/BCNU/MEL or TT | 6 (32%) | 7 (39%) | 13 (35%) |
| Precond. HD-ARA-C | 1 (5%) | 3 (17%) | 4 (11%) |
| Sex mismatch | |||
| (M → F/F → M) | 5/− (26%) | 4/3 (39%) | 9/3 (32%) |
| ABO incompatibility | |||
| (Major/minor/bi-directional) | 3/3/− (32%) | 5/3/3 (61%) | 8/6/3 (46%) |
| CMV (donor → recipient) | |||
| D+ → R+ | 11 (58%) | 14 (78%) | 25 (68%) |
| D+ → R− | 2 (10%) | 1 (6%) | 3 (8%) |
| D− → R+ | 3 (16%) | 3 (17%) | 6 (16%) |
| D− → R− | 3 (16%) | — | 3 (8%) |
| Engraftment | |||
| WBC>1000 × 109 cells/L | 14 (10–19) | 14 (11–21) | 14 (10–21) |
| plt>20 × 109 cells/L | 11 (8–19) | 12 (7–27) | 12 (7–27) |
| plt>50 × 109 cells/L | 12 (10–95) | 13 (10–27) | 13 (10–95) |
| T-cell mixed chimerism (in %) | 17 | 22 | 19 |
| CsA discontinuation | |||
| Median day (range) | 150 (70–250) | 109 (30–202) | 126 (30–250) |
| Acute GvHD | |||
| No. of evaluable pts | 18 | 18 | 36 |
| 0 | 12 (67%) | 11 (61%) | 23 (64%) |
| I | 6 (33%) | 3 (17%) | 9 (25%) |
| II | 0 | 2 (11%) | 2 (5%) |
| III–IV | 0 | 2 (11%) | 2 (5%) |
| Chronic GvHD | |||
| No. of evaluable pts | 18 | 17 | 35 |
| No | 14 (78%) | 15 (88%) | 30 (83%) |
| Limited | 4 (22%) | 1 (6%) | 5 (14%) |
| Extensive | 0 | 1 (6%) | 1 (3%) |
| Severity chronic GvHDd | |||
| Mild | 3 (17%) | 0 | 3 (9%) |
| Moderate | 1 (5%) | 1 (6%) | 2 (6%) |
| Severe | 0 | 1 (6%) | 1 (3%) |
Abbreviations: AA=aplastic anemia; PNH=paroxysmal nocturnal hemoglobinuria; REL=relapse rate
All patients received post-transplant CsA only, except one patient in the Camapth-20/15 group who received additional low-dose MTX (5 mg/m2 on day +1, day +3).
a
One with persistent extramedullary disease, one with active hemophagocytosis.
b
Standard risk: AML or ALL in CR-1, AA or PNH.
c
Busi/Cy and TBI/VP16/Cy, standard myeloablative conditionings; Flu/BCNU/MEL or TT, fludarabine-based reduced toxicity regimens. Precond HD-ARA-C, patients with active disease received 1 week before conditioning high-dose Ara-C.
d
Severity was assessed according to National Institutes of Health consensus (Biol Blood Marrow Transplant 2005; 11(12): 945–956).