Table 1.
Patient Characteristics Overall and by Planned Tacrolimus Duration
| Variable | Planned Tacrolimus Stop Date
|
|||||
|---|---|---|---|---|---|---|
| Day +60, +90, or +120 (n = 105)*,† | Day +90 (n = 47) | Day +60 (n = 55) | ||||
| Patient age, yr | ||||||
| Median (range) | 61 | (13–74) | 61 | (19–73) | 60 | (13–74) |
| ≥65 yr, n (%) | 36 | (34) | 15 | (32) | 19 | (35) |
| Male sex, n (%) | 75 | (71) | 39 | (83) | 34 | (62) |
| Feasibility of reduced IS, n (%) | ||||||
| Feasible to stop early | 63 | (60) | 23 | (49) | 38 | (69) |
| Not feasible | 42 | (40) | 24 | (51) | 17 | (31) |
| Reasons for infeasibility of reduced IS, n (%) | ||||||
| Acute GVHD | 20 | (19) | 10 | (21) | 10 | (18) |
| Grade II | 19 | 9 | 10 | |||
| Grade III-IV | 1 | 1 | 0 | |||
| Graft failure or <5% donor T cells | 10 | (10) | 6 | (13) | 4 | (7) |
| Relapse | 9 | (9) | 6 | (13) | 2 | (4) |
| NRM | 3 | (3) | 2 | (4) | 1 | (2) |
| Diagnosis, n (%) | ||||||
| AML | 45 | (43) | 13 | (28) | 30 | (55) |
| ALL | 8 | (8) | 4 | (9) | 4 | (7) |
| MDS or MPN | 19 | (18) | 10 | (21) | 8 | (15) |
| CMML or CML | 3 | (3) | 1 | (2) | 2 | (4) |
| Aggressive NHL | 13 | (12) | 7 | (15) | 6 | (11) |
| Hodgkin lymphoma | 8 | (8) | 4 | (9) | 4 | (7) |
| Indolent NHL, MCL or CLL | 5 | (5) | 4 | (9) | 1 | (2) |
| Multiple myeloma | 4 | (4) | 4 | (9) | 0 | (0) |
| Refined DRI group, n (%) | ||||||
| Low risk | 12 | (11) | 6 | (13) | 5 | (9) |
| Intermediate risk | 73 | (70) | 33 | (70) | 39 | (71) |
| High risk‡ | 20 | (19) | 8 | (17) | 11 | (20) |
| Patient CMV IgG positive, n (%) | 60 | (57) | 26 | (55) | 32 | (58) |
| CMV mismatch, n (%) | 38 | (36) | 14 | (30) | 22 | (40) |
| Donor age, yr, median (range) | 38 | (17–68) | 40 | (17–68) | 33 | (18–61) |
| Class I and II antigen mismatches,§ | ||||||
| Median (range) | 5 | (1–5) | 5 | (1–5) | 5 | (2–5) |
| 5, n (%) | 59 | (56) | 24 | (51) | 32 | (58) |
| 4, n (%) | 23 | (22) | 11 | (23) | 12 | (22) |
| 3, n (%) | 19 | (18) | 9 | (19) | 10 | (18) |
| 1–2, n (%) | 4 | (4) | 3 | (6) | 1 | (2) |
| Female donor for male patient, n | 25 | (24) | 15 | (32) | 9 | (16) |
| Cell dose infused, median (IQR) | ||||||
| Total nucleated cells ×108/kg | 4.6 | (3.9–5.3) | 4.2 | (3.8–5.1) | 4.9 | (4.2–5.4) |
| CD3+ cells ×107/kg | 4.2 | (3.4–5.4) | 4.0 | (3.4–5.0) | 4.8 | (3.5–5.7) |
| CD34+ cells ×106/kg | 4.1 | (3.5–5.3) | 4.3 | (3.0–5.3) | 4.1 | (3.6–5.2) |
| Post-BMT maintenance therapy, n (%) | 17‖ | (16) | 4 | (9) | 13 | (24) |
AML indicates acute myelogenous leukemia; ALL, acute lymphoblastic leukemia or lymphoma; CLL, chronic lymphocytic leukemia; CMML, chronic myelomonocytic leukemia; CML, chronic myeloid leukemia; CMV, cytomegalovirus; DRI, disease risk index; IQR, interquartile range; IS, immunosuppression; MDS, myelodysplastic syndrome; MPN, myeloproliferative neoplasm; NHL, non-Hodgkin lymphoma.
Patients assigned to particular tacrolimus duration, regardless of actual duration.
All percentages are for column-wise comparisons.
None were very high-risk.
Antigen mismatching in any direction; composite of HLA-A, -B, -Cw, -DRB1, and -DQB1.
BCR-ABL tyrosine kinase inhibitor (n = 5 patients), sorafenib (n = 5), azacitidine (n = 5), rituximab (n = 2).