Table 1:
Definitions of late events and patient population evaluated for each event.
Event | Definition | Censoring criteria | Denominator | |
---|---|---|---|---|
Subsequent systemic therapy for underlying disease | Subsequent transplant | |||
Late significant cytopenias | Cytopenias that required red blood cell or platelet transfusions, or growth factors support. Occurred and/or persisted beyond 90 days after first CAR-T cell infusion. |
Yes | Yes | N=19 Included patients with ongoing CR without diagnosis of subsequent MDS. |
Late hypogammaglobulinemia | IgG levels < 400 mg/dL and/or intravenous immunoglobulin (IVIG) replacement. Occurred and/or persisted beyond 90 days after first CAR-T cell infusion. |
Yes | Yes | N=42 Included patients with available IgG data > 90 days after CAR-T cells |
Late infections | Any infection documented in medical records (with or without microbiologic or radiologic evidence). Occurred and/or persisted beyond 90 days after first CAR-T cell infusion. We considered two different infection events if: (1) occur at different time points (2) different pathogen groups (viral, bacterial, fungal, parasite) were identified (even if documented at the same time point) or (3) different non-adjacent organs were affected (even if documented at the same time point). |
Yes | Yes | N=54 Included patients with available infection data > 90 days after CAR-T cells |
Subsequent malignancies | All malignancies with pathology confirmation that were diagnosed after CAR-T cell administration. | No | Yes | N=86 Entire cohort |
Immune-related events | Any possible immune-related condition (except infections), even without a formal diagnostic confirmation. Occurred and/or persisted beyond 90 days after first CAR-T cell infusion. |
No | Yes | N=86 Entire cohort |
Psychiatric and neurologic disorders | Occurred and/or persisted beyond 90 days after first CAR-T cell infusion. | No | No | N=86 Entire cohort |
GVHD | GVHD requiring systemic therapy. | No | Yes | N=15 Patients with history of allogeneic HCT prior to first CAR-T cell infusion. |