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. Author manuscript; available in PMC: 2021 Jan 1.
Published in final edited form as: Biol Blood Marrow Transplant. 2019 Aug 13;26(1):26–33. doi: 10.1016/j.bbmt.2019.08.003

Table 4:

Summary of Late Events after CD19 targeted CAR-T cells

Late adverse events* Entire cohort (N=86) Ongoing CR (N=21) Non-ongoing CR (N=65) p-value**

Cytopenias (evaluated only in patients with ongoing CR and no diagnosis of subsequent MDS) - 3/ 19 (16%) - -

Hypogammaglobulinemia (% of patients with available data) 28/42 (67%) 14/19 (74%) 14/ 23 (61%) 0.51

Infection density; mean number of infections/100 days at risk (Number of patients evaluated) 0.57 (53) 0.57 (20) 0.58 (33) 0.58

Subsequent malignancies (%) 0.08
- All subsequent malignancies 13 (15%) 6 (29%) 7 (11%)

- MDS 4 (5%) 2 (10%) 2 (3%) 0.25
- non-melanoma skin cancer 6 (7%) 2 (10%) 4 (6%) 0.63

Immune-related events (%) 7 (8%) 2 (10%) 5 (8%) 1.00

Neurologic events (%) 9 (10%) 2 (10%) 7 (11%) 1.00
Patients with CVA/TIA 4 (5%) 0 (0%) 4 (5%) 0.57

Psychiatric events (%) 8 (9%) 2 (10%) 6 (9%) 1.00

GVHD (% of patients with prior allogeneic HCT) 3/15 (20%) 3/8 (38%) 0/7 (0%) 0.20
*

Number of patients with late adverse evens

**

Ongoing CR versus non-ongoing CR. P-values calculated using Fisher’s exact test.

P-value calculated using t-test from 100 bootstrap samples