Baseline demographics and characteristics in Part 2
| . | Ibrutinib plus RICE/RVICI (n = 35) . | RICE/RVICI (n = 16) . |
|---|---|---|
| Median age at randomization, y (range) | 15.0 (5.0-19.0) | 14.5 (3.0-18.0) |
| 1-5, n (%) | 2 (6) | 2 (13) |
| 6-11, n (%) | 5 (14) | 2 (13) |
| 12-17, n (%) | 23 (66) | 11 (69) |
| ≥18, n (%) | 5 (14) | 1 (6) |
| Male, n (%) | 23 (66) | 13 (81) |
| Race, n (%) | ||
| White | 22 (63) | 8 (50) |
| Black | 0 | 1 (6) |
| Asian | 8 (23) | 6 (38) |
| Other | 2 (6) | 1 (6) |
| Time in months from initial diagnosis to randomization, median (range) | 8.1 (3.0-69.0) | 6.6 (2.0-46.0) |
| BSA (m2) | ||
| Median (range) | 1.6 (0.7-2.1) | 1.5 (0.7-2.1) |
| Type of mature B-cell NHL at enrollment, n (%) | ||
| Burkitt-like lymphoma | 1 (3) | 1 (6) |
| BL | 12 (34) | 4 (25) |
| Burkitt leukemia | 4 (11) | 1 (6) |
| DLBCL | 12 (34) | 8 (50) |
| Primary mediastinal B-cell lymphoma | 6 (17) | 0 |
| Other pediatric mature B-cell NHL | 0 | 2 (13) |
| CNS involvement, n (%) | 1 (3) | 1 (6) |
| Bone marrow involvement, n (%) | 7 (20) | 5 (31) |
| First relapse, n (%) | ||
| Burkitt-like lymphoma | 1 (3) | 1 (6) |
| BL | 12 (34) | 4 (25) |
| Burkitt leukemia | 4 (11) | 1 (6) |
| DLBCL | 12 (34) | 8 (50) |
| Primary mediastinal B-cell lymphoma | 6 (17) | 0 |
| Other pediatric mature B-cell NHL | 0 | 2 (13) |
| Second relapse, n (%)∗ | 2 (6) | 0 |
| BL | 1 (3) | 0 |
| DLBCL | 1 (3) | 0 |
| CSF cytologic evaluation, n (%) | ||
| CSF-positive | 5 (14) | 1 (6) |
| CSF-negative | 30 (86) | 15 (94) |
| Prior rituximab treatment, n (%) | 30 (86) | 9 (56) |
| Time in months from start of latest prior line of therapy to progression on latest prior line of therapy, median (range) | 6.6 (1.3-68.6) | 5.6 (1.5-37.8) |
| . | Ibrutinib plus RICE/RVICI (n = 35) . | RICE/RVICI (n = 16) . |
|---|---|---|
| Median age at randomization, y (range) | 15.0 (5.0-19.0) | 14.5 (3.0-18.0) |
| 1-5, n (%) | 2 (6) | 2 (13) |
| 6-11, n (%) | 5 (14) | 2 (13) |
| 12-17, n (%) | 23 (66) | 11 (69) |
| ≥18, n (%) | 5 (14) | 1 (6) |
| Male, n (%) | 23 (66) | 13 (81) |
| Race, n (%) | ||
| White | 22 (63) | 8 (50) |
| Black | 0 | 1 (6) |
| Asian | 8 (23) | 6 (38) |
| Other | 2 (6) | 1 (6) |
| Time in months from initial diagnosis to randomization, median (range) | 8.1 (3.0-69.0) | 6.6 (2.0-46.0) |
| BSA (m2) | ||
| Median (range) | 1.6 (0.7-2.1) | 1.5 (0.7-2.1) |
| Type of mature B-cell NHL at enrollment, n (%) | ||
| Burkitt-like lymphoma | 1 (3) | 1 (6) |
| BL | 12 (34) | 4 (25) |
| Burkitt leukemia | 4 (11) | 1 (6) |
| DLBCL | 12 (34) | 8 (50) |
| Primary mediastinal B-cell lymphoma | 6 (17) | 0 |
| Other pediatric mature B-cell NHL | 0 | 2 (13) |
| CNS involvement, n (%) | 1 (3) | 1 (6) |
| Bone marrow involvement, n (%) | 7 (20) | 5 (31) |
| First relapse, n (%) | ||
| Burkitt-like lymphoma | 1 (3) | 1 (6) |
| BL | 12 (34) | 4 (25) |
| Burkitt leukemia | 4 (11) | 1 (6) |
| DLBCL | 12 (34) | 8 (50) |
| Primary mediastinal B-cell lymphoma | 6 (17) | 0 |
| Other pediatric mature B-cell NHL | 0 | 2 (13) |
| Second relapse, n (%)∗ | 2 (6) | 0 |
| BL | 1 (3) | 0 |
| DLBCL | 1 (3) | 0 |
| CSF cytologic evaluation, n (%) | ||
| CSF-positive | 5 (14) | 1 (6) |
| CSF-negative | 30 (86) | 15 (94) |
| Prior rituximab treatment, n (%) | 30 (86) | 9 (56) |
| Time in months from start of latest prior line of therapy to progression on latest prior line of therapy, median (range) | 6.6 (1.3-68.6) | 5.6 (1.5-37.8) |
BSA, body surface area; CNS, central nervous system; CSF, cerebrospinal fluid.
Following Part 1, the decision was made to restrict inclusion to those in first relapse or refractory to first-line therapy. The protocol was amended but whilst the protocol was being approved in all sites, 2 patients in second relapse were included.