Patient, donor, and disease characteristics by treatment arm
| . | tac/mtx, n = 70 . | siro/tac/mtx, n = 73 . | P . | |||
|---|---|---|---|---|---|---|
| N . | % . | N . | % . | |||
| Age at transplant, y | .37 | |||||
| 1-4 | 15 | 21 | 20 | 27 | ||
| 5-9 | 17 | 24 | 24 | 33 | ||
| 10-14 | 21 | 30 | 14 | 19 | ||
| 15+ | 17 | 24 | 15 | 21 | ||
| Sex | ||||||
| Female | 29 | 41 | 30 | 41 | .97 | |
| Male | 41 | 59 | 43 | 59 | ||
| Immunophenotype | ||||||
| B-precursor | 55 | 79 | 58 | 79 | ||
| T cell | 13 | 19 | 14 | 19 | .96 | |
| Mixed lineage (MLL) | 2 | 2.9 | 1 | 1.4 | ||
| Philadelphia chromosome positive | ||||||
| No | 65 | 93 | 64 | 88 | .30 | |
| Yes | 5 | 7 | 9 | 12 | ||
| Extramedullary disease at diagnosis | ||||||
| No | 59 | 84 | 60 | 82 | .73 | |
| Central nervous system | 10 | 14 | 12 | 16 | ||
| Other site | 1 | 1 | 1 | 1 | ||
| Extramedullary disease in CR2 patients, N = 94 | ||||||
| Diagnosis | Relapse | |||||
| No | No | 27 | 59 | 29 | 60 | .76 |
| No | Yes | 11 | 24 | 10 | 21 | |
| Yes | No | 7 | 15 | 6 | 13 | |
| Yes | Yes | 1 | 2 | 3 | 6 | |
| Cranial radiation at initial treatment | ||||||
| No | 57 | 81 | 61 | 84 | .74 | |
| Yes | 13 | 19 | 12 | 16 | ||
| Total dose of radiation therapy, cGy: median (range) | 1800 (1200-1800) | 1200 (600-2400) | ||||
| Relapse risk group assessment | ||||||
| High-risk CR1 | 24 | 34 | 25 | 34 | .99 | |
| High-risk CR2 | 34 | 49 | 35 | 48 | ||
| Intermediate-risk CR2 | 12 | 17 | 13 | 18 | ||
| Stem cell source | ||||||
| Matched sibling | 38 | 54 | 40 | 55 | .99 | |
| Other related donor | 2 | 3 | 2 | 3 | ||
| Unrelated donor: BM or PBSC | 16 | 23 | 18 | 25 | ||
| Unrelated donor: cord blood | 14 | 20 | 13 | 18 | ||
| CMV status | ||||||
| Donor | Recipient | |||||
| Negative | Negative | 31 | 48 | 27 | 39 | .17 |
| Negative | Positive | 15 | 23 | 17 | 25 | |
| Positive | Negative | 3 | 5 | 11 | 16 | |
| Positive | Positive | 16 | 25 | 14 | 20 | |
| MRD status pretransplant | ||||||
| Negative | 38 | 54 | 37 | 51 | .39 | |
| Positive, <0.1% | 7 | 10 | 6 | 8 | ||
| Positive, 0.1%+ | 5 | 7 | 12 | 16 | ||
| Not available* | 20 | 29 | 18 | 25 | ||
| . | tac/mtx, n = 70 . | siro/tac/mtx, n = 73 . | P . | |||
|---|---|---|---|---|---|---|
| N . | % . | N . | % . | |||
| Age at transplant, y | .37 | |||||
| 1-4 | 15 | 21 | 20 | 27 | ||
| 5-9 | 17 | 24 | 24 | 33 | ||
| 10-14 | 21 | 30 | 14 | 19 | ||
| 15+ | 17 | 24 | 15 | 21 | ||
| Sex | ||||||
| Female | 29 | 41 | 30 | 41 | .97 | |
| Male | 41 | 59 | 43 | 59 | ||
| Immunophenotype | ||||||
| B-precursor | 55 | 79 | 58 | 79 | ||
| T cell | 13 | 19 | 14 | 19 | .96 | |
| Mixed lineage (MLL) | 2 | 2.9 | 1 | 1.4 | ||
| Philadelphia chromosome positive | ||||||
| No | 65 | 93 | 64 | 88 | .30 | |
| Yes | 5 | 7 | 9 | 12 | ||
| Extramedullary disease at diagnosis | ||||||
| No | 59 | 84 | 60 | 82 | .73 | |
| Central nervous system | 10 | 14 | 12 | 16 | ||
| Other site | 1 | 1 | 1 | 1 | ||
| Extramedullary disease in CR2 patients, N = 94 | ||||||
| Diagnosis | Relapse | |||||
| No | No | 27 | 59 | 29 | 60 | .76 |
| No | Yes | 11 | 24 | 10 | 21 | |
| Yes | No | 7 | 15 | 6 | 13 | |
| Yes | Yes | 1 | 2 | 3 | 6 | |
| Cranial radiation at initial treatment | ||||||
| No | 57 | 81 | 61 | 84 | .74 | |
| Yes | 13 | 19 | 12 | 16 | ||
| Total dose of radiation therapy, cGy: median (range) | 1800 (1200-1800) | 1200 (600-2400) | ||||
| Relapse risk group assessment | ||||||
| High-risk CR1 | 24 | 34 | 25 | 34 | .99 | |
| High-risk CR2 | 34 | 49 | 35 | 48 | ||
| Intermediate-risk CR2 | 12 | 17 | 13 | 18 | ||
| Stem cell source | ||||||
| Matched sibling | 38 | 54 | 40 | 55 | .99 | |
| Other related donor | 2 | 3 | 2 | 3 | ||
| Unrelated donor: BM or PBSC | 16 | 23 | 18 | 25 | ||
| Unrelated donor: cord blood | 14 | 20 | 13 | 18 | ||
| CMV status | ||||||
| Donor | Recipient | |||||
| Negative | Negative | 31 | 48 | 27 | 39 | .17 |
| Negative | Positive | 15 | 23 | 17 | 25 | |
| Positive | Negative | 3 | 5 | 11 | 16 | |
| Positive | Positive | 16 | 25 | 14 | 20 | |
| MRD status pretransplant | ||||||
| Negative | 38 | 54 | 37 | 51 | .39 | |
| Positive, <0.1% | 7 | 10 | 6 | 8 | ||
| Positive, 0.1%+ | 5 | 7 | 12 | 16 | ||
| Not available* | 20 | 29 | 18 | 25 | ||
A portion of pre-HCT MRD samples were not available due to patient/parent refusal of biology studies (rare) or more commonly consent being obtained after pre-HCT BM was performed locally and patient/parent refusal of a second “optional” research BM sample.