HLH-like Toxicities Study
This study aims to characterize and compare pre-infusion and 1-month post-infusion bone marrow samples in patients who did and did not develop HLH-like toxicities after tisagenlecleucel.
ADDITIONAL ELIGIBILITY
HLH-like Toxicities Definition:
For the purposes of this study, we define HLH-like toxicities as a peak ferritin >10,000 ng/mL with at least two of the following within 30 days of CAR T infusion in a patient that had CRS:
Elevation of AST, ALT, or bilirubin ≥ grade 3 (AST/ALT: >5-20x ULN if baseline normal, >5-20x baseline if baseline abnormal; Bilirubin: >3-10x ULN if baseline normal, >3-10x baseline if baseline abnormal)
Renal dysfunction (as defined by increase in serum creatinine by ≥0.3mg/dL in 48 hours or 1.5-1.9x baseline in 7 days)
Hypoxemia or pulmonary edema
Coagulopathy (fibrinogen <150mg/dL or <LLN; PT/IRN> ULN; PTT> ULN)
Hemophagocytosis in bone marrow or tissue biopsy
COLLECTION
previously banked bone marrow samples from pre and 1mo post-CAR T with and/or without HLH-like toxicities
REQUIREMENTS
Institutional biobanking ICF that allows for future research on banked samples OR Foresight ICF signed