Univariable and multivariable analyses for factors that had in impact on EFS in patients who achieved MRD-negative CR
| Variable . | Univariable analysis . | P . | Multivariable analysis . | P . | ||
|---|---|---|---|---|---|---|
| HR . | 95% CI . | HR . | 95% CI . | |||
| LDH (per 100 U/L, prelymphodepletion) | 1.49 | 1.22-1.80 | <.0001 | 1.39 | 1.12-1.74 | .003 |
| Bridging systemic therapy* | 5.66 | 2.56-12.5 | <.0001 | —† | — | |
| Platelet count (per 50 000/μL, prelymphodepletion) | 0.57 | 0.42-0.76 | .0002 | 0.65 | 0.47-0.88 | .006 |
| Extramedullary disease | 3.57 | 1.66-7.65 | .001 | — | — | |
| Fludarabine added to lymphodepletion | 0.30 | 0.13-0.66 | .003 | 0.34 | 0.15-0.78 | .011 |
| IL-6 (pg/mL, prelymphodepletion) | 1.02 | 1.01-1.03 | .005 | — | — | |
| Marrow blasts by flow cytometry, % | 1.01 | 1.00-1.03 | .006 | — | — | |
| High-risk cytogenetics‡ | 2.48 | 1.12-5.50 | .03 | — | — | |
| Neutrophil count (1000/μL, prelymphodepletion) | 0.73 | 0.55-0.97 | .03 | — | — | |
| Soluble TNFRp55 (day 0), pg/mL | 4.84 | 1.07-21.8 | .04 | —§ | — | |
| IL-2 (day 0), pg/mL | 3.24 | 1.05-10.0 | .04 | — | — | |
| IL-8 (pg/mL, prelymphodepletion) | 1.78 | 1.00-3.15 | .05 | — | — | |
| Soluble TIM-3 (ng/mL; prelymphodepletion) | 1.05 | 1.00-1.11 | .06 | — | — | |
| Dose level (2 × 105 vs 2 × 106 CAR T cells per kg) | 0.51 | 0.24-1.11 | .09 | — | — | |
| No. of previous regimens | 1.13 | 0.97-1.32 | .1 | — | — | |
| Previous allogeneic HCT | 1.65 | 0.79-3.44 | .2 | — | — | |
| Previous blinatumomab therapy | 1.27 | 0.52-3.12 | .6 | |||
| ECOG PS | 1.18 | 0.62-2.26 | .6 | — | — | |
| Age, y | 1.00 | 0.98-1.01 | .7 | — | — | |
| Time from leukapheresis to lymphodepletion, d | 1.52 | 0.64-3.62 | .3 | |||
| CD4+:CD8+ CAR T-cell ratio (peak expansion) | 1.20 | 0.86-1.68 | .3 | |||
| CD4+:CD8+ CAR T-cell ratio (AUC from day 0 to day 28) | 1.09 | 0.76-1.55 | .6 | |||
| CD4+:CD8+ CAR T-cell ratio (fold change from infusion product to peak expansion) | 1.21 | 0.81-1.81 | .4 | |||
| CAR T-cell counts (transgene log10 copies/μg of DNA; AUC28) | 0.98 | 0.56-1.71 | .9 | — | — | |
| Variable . | Univariable analysis . | P . | Multivariable analysis . | P . | ||
|---|---|---|---|---|---|---|
| HR . | 95% CI . | HR . | 95% CI . | |||
| LDH (per 100 U/L, prelymphodepletion) | 1.49 | 1.22-1.80 | <.0001 | 1.39 | 1.12-1.74 | .003 |
| Bridging systemic therapy* | 5.66 | 2.56-12.5 | <.0001 | —† | — | |
| Platelet count (per 50 000/μL, prelymphodepletion) | 0.57 | 0.42-0.76 | .0002 | 0.65 | 0.47-0.88 | .006 |
| Extramedullary disease | 3.57 | 1.66-7.65 | .001 | — | — | |
| Fludarabine added to lymphodepletion | 0.30 | 0.13-0.66 | .003 | 0.34 | 0.15-0.78 | .011 |
| IL-6 (pg/mL, prelymphodepletion) | 1.02 | 1.01-1.03 | .005 | — | — | |
| Marrow blasts by flow cytometry, % | 1.01 | 1.00-1.03 | .006 | — | — | |
| High-risk cytogenetics‡ | 2.48 | 1.12-5.50 | .03 | — | — | |
| Neutrophil count (1000/μL, prelymphodepletion) | 0.73 | 0.55-0.97 | .03 | — | — | |
| Soluble TNFRp55 (day 0), pg/mL | 4.84 | 1.07-21.8 | .04 | —§ | — | |
| IL-2 (day 0), pg/mL | 3.24 | 1.05-10.0 | .04 | — | — | |
| IL-8 (pg/mL, prelymphodepletion) | 1.78 | 1.00-3.15 | .05 | — | — | |
| Soluble TIM-3 (ng/mL; prelymphodepletion) | 1.05 | 1.00-1.11 | .06 | — | — | |
| Dose level (2 × 105 vs 2 × 106 CAR T cells per kg) | 0.51 | 0.24-1.11 | .09 | — | — | |
| No. of previous regimens | 1.13 | 0.97-1.32 | .1 | — | — | |
| Previous allogeneic HCT | 1.65 | 0.79-3.44 | .2 | — | — | |
| Previous blinatumomab therapy | 1.27 | 0.52-3.12 | .6 | |||
| ECOG PS | 1.18 | 0.62-2.26 | .6 | — | — | |
| Age, y | 1.00 | 0.98-1.01 | .7 | — | — | |
| Time from leukapheresis to lymphodepletion, d | 1.52 | 0.64-3.62 | .3 | |||
| CD4+:CD8+ CAR T-cell ratio (peak expansion) | 1.20 | 0.86-1.68 | .3 | |||
| CD4+:CD8+ CAR T-cell ratio (AUC from day 0 to day 28) | 1.09 | 0.76-1.55 | .6 | |||
| CD4+:CD8+ CAR T-cell ratio (fold change from infusion product to peak expansion) | 1.21 | 0.81-1.81 | .4 | |||
| CAR T-cell counts (transgene log10 copies/μg of DNA; AUC28) | 0.98 | 0.56-1.71 | .9 | — | — | |
IL-6, interleukin-6.
Between leukapheresis and CAR T-cell infusion.
Correlated strongly with LDH (P < .01) and platelet count (P = .02); therefore, it was not included in the multivariable model.
Defined as having 1 or more of the following: t(9;22) Ph+BCR-ABL t(v;11) MLL rearrangement, low hypodiploidy, near triploidy, iAMP21, or complex karyotype with ≥5 abnormalities.
Correlated strongly with platelet count; therefore, it was not included in the multivariable model.