Table I.
Patient-, disease-, and transplant-related characteristics
| BMT CTN-0201 | BMT CTN-0901 | |||
|---|---|---|---|---|
|
| ||||
| Bone marrow |
Peripheral blood |
Reduced intensity |
Myeloablative | |
|
| ||||
| N | 94 | 93 | 77 | 86 |
|
| ||||
| Age (years), mean (SD) | 44 (15) | 42 (15) | 53 (10) | 53 (10) |
|
| ||||
| Gender, n (%) | ||||
| Male | 56 (60) | 59 (63) | 34 (44) | 46 (53) |
| Female | 38 (40) | 34 (37) | 43 (56) | 40 (47) |
|
| ||||
| Donor | ||||
| Matched sibling | 0 | 0 | 47 (61) | 48 (56) |
| Matched unrelated | 94 (100) | 93 (100) | 30 (39) | 38 (44) |
|
| ||||
| GVHD prophylaxis, n (%) | ||||
| CsA/MTX | 24 (26) | 19 (20) | 2 (3) | 1 (1) |
| Tac/MTX | 61 (65) | 67 (72) | 65 (84) | 73 (85) |
| Other | 9 (10) | 7 (8) | ||
| Tac/Siro | 8 (10) | 8 (9) | ||
| Tac/MMF | 2 (3) | 4 (5) | ||
|
| ||||
| Conditioning, n (%) | ||||
| Cy/TBI | 35 (37) | 40 (43) | 0 | 3 (3) |
| Bu/Cy | 38 (40) | 28 (30) | 0 | 28 (33) |
| Flu/Bu4 | 0 | 0 | 0 | 55 (64) |
| Flu/Mel | 8 (9) | 10 (11) | 13 (17) | 0 |
| Flu/Bu2/ATG | 13 (14) | 15 (16) | 0 | 0 |
| Flu/Bu2 | 0 | 0 | 64 (83) | 0 |
|
| ||||
| Conditioning intensity, n (%) | ||||
| Myeloablative | 73 (78) | 68 (73) | 0 | 86 (100) |
| Reduced intensity | 21 (22) | 25 (27) | 77 (100) | 0 |
|
| ||||
| Disease risk1, n (%) | ||||
| Good risk | 74 (79) | 60 (65) | 38 (49) | 49 (57) |
| Poor risk | 20 (21) | 33 (35) | 37 (48) | 36 (42) |
| Unknown | 0 | 0 | 2 (3) | 1 (1) |
|
| ||||
| Recipient CMV serostatus, n (%) | ||||
| Positive | 51 (54) | 44 (47) | 49 (64) | 56 (65) |
| Negative | 43 (46) | 49 (53) | 27 (35) | 30 (35) |
| Unknown | 0 | 0 | 1 (1) | 0 |
|
| ||||
| Underlying disease, n (%) | ||||
| AML | 45 (48) | 41 (44) | 62 (81) | 66 (77) |
| ALL | 14 (15) | 17 (18) | 0 | 0 |
| MDS | 20 (21) | 18 (19) | 15 (19) | 20 (23) |
| MPN | 15 (16) | 17 (19) | 0 | 0 |
None of the variables were significant between randomized groups.
Defined according to the original BMT-CTN study. In CTN-0201, poor risk was defined as AML in third or subsequent remission or not in remission, ALL not in remission, MDS with excess blasts in transformation, chronic myeloid leukaemia in blast phase, and chronic myelomonocytic leukaemia in any stage. In CTN-0901, poor risk was defined as AML with unfavourable risk cytogenetics, FLT3 mutation, or complete remission ≥3, and intermediate-II or high risk MDS.
ALL: Acute lymphoblastic leukaemia; AML: Acute myeloid leukaemia; ATG: Anti-thymocyte globulin; BMT CTN: Blood and Marrow Transplant Clinical Trials Network; Bu: Busulfan; CMV: Cytomegalovirus; CsA: Ciclosporin; Cy: Cyclophosphamide; Flu: fludarabine; GVHD: Graft-versus-host disease; MDS: Myelodysplastic syndrome; Mel: Melphalan; MMF: Mycophenolate mofetil; MPN: Myeloproliferative neoplasm; MTX: Methotrexate; SD: standard deviation; Siro: Sirolimus; Tac: Tacrolimus; TBI: Total body irradiation