Figure 5.
Faster T-cell reconstitution and less severe BK virus–associated cystitis/urethritis with ID-PTCy than with HD-PTCy. (A) CD4+ and (B) CD8+ T-cell recovery over 2 years after HCT for each dose level. Both CD4+ and CD8+ T-cell counts were significantly higher for patients in DL2 and DL3 than those treated with HD-PTCy at day +14 and also at other early post-transplant time periods, before counts numerically normalized by day +42. T-cell counts were evaluated before PTCy administration on days +3 and +4, before starting sirolimus and mycophenolate mofetil on day +5, on day +7, weekly for 100 days, and then at days +180, +270, +365, +545 (1.5 years), and +730 (2 years) after transplant. Up to day +21, samples were collected on the day labeled. Windows for subsequent samples are as follows: days +28 to +99 ± 3 days; days +180 and +270 ± 14 days; and all following time points ± 30 days. Patients who did not engraft and those with persistent mixed T-cell chimerism were not included. (C) Duration of symptomatic BK virus–associated cystitis/urethritis and hemorrhagic cystitis. BK cystitis symptoms were defined by the presence of dysuria, urinary urgency, urinary frequency, bladder spasms, or macroscopic hematuria occurring within the first 180 days after HCT in patients with BK viruria. (D) BK virus levels in urine and blood on serial monitoring in the first 100 days after transplant. Mean values with standard error of the means are shown. Statistical comparisons shown are of the AUC of weekly testing over the first 100 days. For panels C-D, patients included are known to be at risk for BK cystitis, defined by BK virus detection in the urine or blood at any point on serial monitoring; 2 patients in DL2 without symptoms but also without any detectable BK virus in urine or blood at any timepoint were excluded in case they were unexposed and not at risk for reactivation. Patients who did not engraft, those with follow-up of <100 days because of relapse or NRM (unrelated to BK virus), or with BK virus–associated cystitis/urethritis symptoms at the time of initiation of conditioning for HCT also were excluded. ∗P < .05; ∗∗P < .01.

Faster T-cell reconstitution and less severe BK virus–associated cystitis/urethritis with ID-PTCy than with HD-PTCy. (A) CD4+ and (B) CD8+ T-cell recovery over 2 years after HCT for each dose level. Both CD4+ and CD8+ T-cell counts were significantly higher for patients in DL2 and DL3 than those treated with HD-PTCy at day +14 and also at other early post-transplant time periods, before counts numerically normalized by day +42. T-cell counts were evaluated before PTCy administration on days +3 and +4, before starting sirolimus and mycophenolate mofetil on day +5, on day +7, weekly for 100 days, and then at days +180, +270, +365, +545 (1.5 years), and +730 (2 years) after transplant. Up to day +21, samples were collected on the day labeled. Windows for subsequent samples are as follows: days +28 to +99 ± 3 days; days +180 and +270 ± 14 days; and all following time points ± 30 days. Patients who did not engraft and those with persistent mixed T-cell chimerism were not included. (C) Duration of symptomatic BK virus–associated cystitis/urethritis and hemorrhagic cystitis. BK cystitis symptoms were defined by the presence of dysuria, urinary urgency, urinary frequency, bladder spasms, or macroscopic hematuria occurring within the first 180 days after HCT in patients with BK viruria. (D) BK virus levels in urine and blood on serial monitoring in the first 100 days after transplant. Mean values with standard error of the means are shown. Statistical comparisons shown are of the AUC of weekly testing over the first 100 days. For panels C-D, patients included are known to be at risk for BK cystitis, defined by BK virus detection in the urine or blood at any point on serial monitoring; 2 patients in DL2 without symptoms but also without any detectable BK virus in urine or blood at any timepoint were excluded in case they were unexposed and not at risk for reactivation. Patients who did not engraft, those with follow-up of <100 days because of relapse or NRM (unrelated to BK virus), or with BK virus–associated cystitis/urethritis symptoms at the time of initiation of conditioning for HCT also were excluded. ∗P < .05; ∗∗P < .01.

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