Skip to main content
Blood Advances logoLink to Blood Advances
. 2021 Feb 23;5(4):1136. doi: 10.1182/bloodadvances.2021004265

Pasquini MC, Hu Z-H, Curran K, et al. Real-world evidence of tisagenlecleucel for pediatric acute lymphoblastic leukemia and non-Hodgkin lymphoma. Blood Adv. 2020;4(21):5414-5424.

PMCID: PMC7903231  PMID: 33620430

There are errors in the cytokine release syndrome (“CRS”) section of Table 2 on page 5417. In the “ELIANA” column, the median number of days to onset should read “3,” the range of days to onset should read “1-22,” the median number of days of duration should read “8,” and the range of days of duration should read “1-36.” In the “JULIET” column, the range of days to onset should read “1-51,” the median number of days of duration should read “7,” and the range of days of duration should read “2-30.”

In the “MRD” row of the “Pivotal trial, % (95% CI)” column of Table 3 on page 5419, “100.0 (n = 64/64)” should read “98.5 (n = 64/65).”

The corrected Tables 2 and 3 are shown below. The errors have been corrected in the published article.

Table 2.

Comparison of safety outcomes of CIBMTR with those of ELIANA and JULIET trials

ALL NHL
End point CIBMTR (n = 255) ELIANA (n = 79) CIBMTR (n = 155) JULIET (n = 115)
CRS
 Any, n (%) 140 (54.9) 61 (77.2) 70 (45.2) 66 (57.4)
 Grade ≥3, n (%) 41 (16.1) 38 (48.1) 7 (4.5) 26 (22.6)
 Time to onset, d
  Median 6 3 4 3
  Range 1-27 1-22 1-14 1-51
 Duration, d
  Median 7 8 5 7
  Range 1-76 1-36 1-33 2-30
Neurotoxicity
 Any, n (%) 69 (27.1) 31 (39.2) 28 (18.1) 23 (20.0)
 Grade ≥3, n (%) 23 (9.0) 10 (12.7) 8 (5.1) 13 (11.3)
 Time to onset, d
  Median 7 8 8 6
  Range 1-80 2-489 2-33 1-323
 Duration, d
  Median 7 7 6.5 13
  Range 1-94 1-50

Table 3.

Comparison of efficacy outcomes of CIBMTR with those of ELIANA and JULIET trials

End point CIBMTR, % (95% CI) Pivotal trial, % (95% CI)
CIBMTR vs ELIANA (n = 249) (n = 79)
 BOR of CR 85.5 (80.6-89.7) 82.3 (72.1-90.0)
 MRD 99.1 (n = 115/116)
(95.3-100)
98.5 (n = 64/65)
(94.4-100)
 DOR
  At 6 mo 78.1 (70.5-84.0) 80.8 (68.0-88.9)
  At 12 mo 60.9 (49.4-70.5) 67.4 (53.2-78.1)
 EFS
  At 6 mo 68.6 (62.0-74.4) 71.7 (59.8-80.6)
  At 12 mo 52.4 (43.4-60.7) 57.2 (44.5-68.0)
 OS
  At 6 mo 88.5 (83.6-92.0) 88.6 (79.3-93.9)
  At 12 mo 77.2 (69.8-83.1) 77.1 (66.1-84.9)
CIBMTR vs JULIET (n = 152) (n = 115)
 ORR (CR + PR) 61.8 (53.6-69.6) 52.2 (42.7-61.6)
 BOR of CR 39.5 (31.6-47.7) 38.3 (29.4-47.8)
 DOR
  At 6 mo 55.3 (42.2-66.6) 66.6 (52.8-77.3)
  At 12 mo 48.4* (33.9-61.5) 62.7 (48.7-73.9)
 PFS
  At 6 mo 38.7 (30.5-46.9) 39.0 (29.7-48.2)
  At 12 mo 26.4* (17.2-36.6) 34.7 (25.7-43.9)
 OS
  At 6 mo 70.7 (62.2-77.6) 61.2 (51.6-69.5)
  At 12 mo 56.3 (44.2-66.8) 48.2 (38.6-57.1)
*

Less than 10 patients at risk at this time point.


Articles from Blood Advances are provided here courtesy of The American Society of Hematology

RESOURCES