Table 1 Patient demographics and baseline characteristics.

From: Ibrutinib plus CIT for R/R mature B-NHL in children (SPARKLE trial): initial safety, pharmacokinetics, and efficacy

 

Ibrutinib plus modified RICE (n = 11)

Ibrutinib plus RVICI (n = 10)

Median age (range), years

11.0 (3–17)

8.0 (4–15)

Age group, years, n (%)

  1–5

2 (18.2)

2 (20.0)

  6–11

4 (36.4)

6 (60.0)

  12–17

5 (45.5)

2 (20.0)

Sex, n (%)

  Female

3 (27.3)

1 (10.0)

  Male

8 (72.7)

9 (90.0)

 Ethnicity, n (%)

  Hispanic or Latino

2 (18.2)

0

  Not Hispanic or Latino

6 (54.5)

9 (90.0)

  Unknown

1 (9.1)

0

  Not reported

2 (18.2)

1 (10.0)

Race, n (%)

  White

9 (81.8)

10 (100.0)

  Asian

1 (9.1)

0

  Not reported

1 (9.1)

0

Time from initial diagnosis to first dose of study drug (months)

  Mean (SD)

11.7 (10.94)

10.5 (6.22)

  Median (range)

7.0 (4–37)

8.2 (5–25)

Type of mature B-cell NHL at initial diagnosis, n (%)

  Burkitt-like lymphoma

2 (18.2)

1 (10.0)

  Burkitt lymphoma

4 (36.4)

3 (30.0)

  Burkitt leukemia

2 (18.2)

4 (40.0)

  Diffuse large B-cell lymphoma

3 (27.3)

0

  Primary mediastinal B-cell lymphoma

0

1 (10.0)

  High-grade B-cell lymphoma

0

1 (10.0)

  Other

0

0

Extra nodal sites, n (%)

  Central nervous system

0

4 (40.0)

  Bone marrow

3 (27.3)

4 (40.0)

  Other

9 (81.8)

9 (90.0)

Prior lines of therapy, n (%)

  1

10 (90.9)

4 (40.0)

  >1

1 (9.1)

6 (60.0)

  1. NHL non-Hodgkin lymphoma, SD standard deviation, modified RICE rituximab, ifosfamide, carboplatin, and etoposide, with the addition of dexamethasone, RVICI vincristine, ifosfamide, carboplatin, idarubicin, that includes dexamethasone.