Recommendations for conduct and reporting of correlative testing
| Tier . | Correlative testing recommendations . |
|---|---|
| Tier 1 | Clinical laboratory tests: before and after LD chemotherapy and at serial time points after infusion CAR T-cell monitoring (flow cytometry– or qPCR-based): at serial time points after infusion |
| Tier 2 | Cytokine analysis: before and after LD chemotherapy and at serial time points after infusion |
| Tier 3 | Detailed CAR T-cell monitoring (eg, high-dimensional flow cytometry–based or transcriptomics-based): before and after LD chemotherapy and at serial time points after infusion Detailed non–CAR T-cell immune monitoring (eg, high-dimensional flow cytometry–based or transcriptomics-based): before and after LD chemotherapy and at serial time points after infusion Tumor microenvironment milieu bone marrow evaluation (eg, high-dimensional flow cytometry–based or transcriptomics-based): before LD chemotherapy and at disease response evaluation Pharmacokinetic monitoring of agents used in LD chemotherapy |
| Tier . | Correlative testing recommendations . |
|---|---|
| Tier 1 | Clinical laboratory tests: before and after LD chemotherapy and at serial time points after infusion CAR T-cell monitoring (flow cytometry– or qPCR-based): at serial time points after infusion |
| Tier 2 | Cytokine analysis: before and after LD chemotherapy and at serial time points after infusion |
| Tier 3 | Detailed CAR T-cell monitoring (eg, high-dimensional flow cytometry–based or transcriptomics-based): before and after LD chemotherapy and at serial time points after infusion Detailed non–CAR T-cell immune monitoring (eg, high-dimensional flow cytometry–based or transcriptomics-based): before and after LD chemotherapy and at serial time points after infusion Tumor microenvironment milieu bone marrow evaluation (eg, high-dimensional flow cytometry–based or transcriptomics-based): before LD chemotherapy and at disease response evaluation Pharmacokinetic monitoring of agents used in LD chemotherapy |
qPCR, quantitative polymerase chain reaction.