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Nano Energy ◽  
2022 ◽  
Vol 93 ◽  
pp. 106800
Author(s):  
Chang Liu ◽  
Zhi Fang ◽  
Jinsong Sun ◽  
Minghui Shang ◽  
Kanghui Zheng ◽  
...  

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1776-1776
Author(s):  
Sanjeet S Dadwal ◽  
Dongyun Yang ◽  
Guido Marcucci ◽  
Sally Mokhtari ◽  
Bernard Tegtmeier ◽  
...  

Abstract CMV recipient seropositivity (R+) and CMVi are independent risk factors for increased mortality after alloHCT. Preemptive therapy (PET) was standard of care until LTV approval by the FDA in November 2017 for CMVi prevention in CMV R+ alloHCT patients (pts). In a registration trial, LTV led to a significant reduction in clinically significant CMVi (CS-CMVi) defined as CMVi requiring PET in both high-risk (HR) or low-risk (LR) recipients. In the HR-group, defined as mismatched related / unrelated donor with at least one mismatch in one of the four HLA-gene loci of HLA-A, -B, -C or -DRB1, haploidentical donor, umbilical cord source or grade ≥2 acute graft-versus-host disease (aGVHD) at randomization, the impact of LTV on CS-CMVi was more robust. Small studies have confirmed the positive impact of LTV on CS-CMVi. Here, we compared the natural history of CMVi and CS-CMVi between the pre-LTV and LTV era in the first 100 days after HR-alloHCT. We also explored the impact on non-relapse mortality (NRM), overall survival (OS), disease free survival (DFS), and incidence of aGVHD between the two eras. In this IRB approved retrospective study, we identified 450 consecutive HR-alloHCT pts who underwent their first HCT from 1/1/2016 to 12/31/2020 at our center. Pre-LTV era was from 1/1/2016 to 2/28/2018 and LTV era was from 3/1/2018 onwards when prophylaxis became standard of care (SOC) for all R+ alloHCT at our institution. In the HR-alloHCT, the uptake of the new SOC was consistent in all HR-R+ pts beginning LTV prophylaxis on day +7 post-HCT. We defined R+ HR-alloHCT pts at high-risk for CMVi or CS-CMVi as described above except for aGVHD (not recorded at time of institution of LTV). CMVi was defined as first time viral load (VL) of >500 genomic copies/ml (gc/ml). CS-CMVi was defined as a VL >500 gc/ml (910 IU/ml) on two consecutive tests done atleast 48 hours apart, that triggered PET (ganciclovir, valganciclovir, foscarnet, cidofovir), or had identification of CMV end organ disease . The incidence of CMVi and CS-CMVi in R+ allo-HCT was compared by LTV era using Gray test. Kaplan-Meier curves and log-rank tests were used for OS and DFS by LTV era. NRM, relapse, acute and chronic GVHD were compared using cumulative incidence curves and Gray test. All tests were 2-sided at 0.05 level. Of the 450 HR-alloHCT pts, 146 were R+ in pre-LTV vs. 246 R+ in LTV era. R+ patient, their eligible underlying disease, and HCT characteristics are shown in Table 1. There was a significant reduction in both CMVi and CS-CMVi in LTV era vs pre-LTV era (24.1% vs 45.2%, and 22.3% vs 44.5% respectively; p <0.001 for both outcomes) in the first 100 days. Compared to pre LTV era, LTV era was associated with significantly reduced CS-CMVi among R+ pts (HR=0.39, 95%CI: 0.26-0.58, p <0.001) in the multivariable Fine and Gray model adjusted for primary diagnosis, donor type and acute GVHD. CMVi was also reduced in the multivariable model (HR=0.41 and 95%CI: 0.28-0.61, p<0.001). Although there were no significant differences in OS, DFS, NRM, relapse, and chronic GVHD between the two eras at 6, 12, and 18 months post-HCT in R+ pts, a trend towards improved OS and DFS in LTV era was noted (p=0.06 and p=0.07) in this patient population. There was a significantly lower rate of grade III-IV acute GVHD in the LTV era (9.2% vs 17.8% at day 100, p=0.012 with HR = 0.49). No case of CMV disease was identified in the first 100 days. LTV has substantially reduced CS-CMVi in the first 100 days post-HCT in HR-R+ pts and resultant burden from PET. We identified a significant reduction in grade III - IV aGVHD in LTV era suggesting that with reduced CMVi, LTV may have a salutary impact on development of aGVHD; this is in agreement with studies showing bidirectional relationship between CMVi and onset of aGVHD. We did not observe a significant difference in OS, DFS, NRM amongst the two eras but there was trend towards higher OS and DFS in LTV era that requires further assessment in a larger multicenter cohort. Lastly, significant burden persists from CS-CMVi in this patient population during the first 100 days of alloHCT that underscores the need of efforts to identify other novel methods to mitigate it. One of the limitations in the LTV era is identifying the clinical scenarios surrounding the CMVi and CS-CMVi that may relate to compliance, absorption from gastrointestinal tract, and affordability or coverage of LTV after discharge from hospital. Figure 1 Figure 1. Disclosures Dadwal: Astellas: Speakers Bureau; Aseptiscope: Consultancy; AlloVir: Research Funding; Shire/Takeda: Research Funding; Merck: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Janssen: Other: Investigator; Karius: Other: Investigator. Marcucci: Novartis: Other: Speaker and advisory scientific board meetings; Agios: Other: Speaker and advisory scientific board meetings; Abbvie: Other: Speaker and advisory scientific board meetings. Taplitz: Merck: Membership on an entity's Board of Directors or advisory committees. Artz: Radiology Partners: Other: Spouse has equity interest in Radiology Partners, a private radiology physician practice. Stein: Amgen: Consultancy, Speakers Bureau; Celgene: Speakers Bureau; Stemline: Speakers Bureau. Forman: Allogene: Consultancy; Lixte Biotechnology: Consultancy, Current holder of individual stocks in a privately-held company; Mustang Bio: Consultancy, Current holder of individual stocks in a privately-held company. Al Malki: Neximmune: Consultancy; Jazz Pharmaceuticals, Inc.: Consultancy; CareDx: Consultancy; Rigel Pharma: Consultancy; Hansa Biopharma: Consultancy.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1784-1784
Author(s):  
Omer Hassan Jamy ◽  
John Dasher ◽  
Yanjun Chen ◽  
Kevin D. Battles ◽  
Donna Salzman ◽  
...  

Abstract Background: Patients undergoing allogeneic hematopoietic stem cell transplantation (allo-hsct) can develop complications such as life-threatening infections, multi-system organ failure, ICU admission and ventilator support in the immediate post-transplant period. Whereas outcomes of these complications, particularly ICU admission and ventilator support, are known to be poor, little is known about the risk factors leading to them. Methods: We conducted a retrospective study to analyze the impact of pre-transplant risk factors on acute inpatient complications, focusing on ICU admission, ventilator support and multi-system organ failure, following allo-hsct at the University of Alabama at Birmingham (UAB) between 2008 and 2016. Mortality rates and survival outcomes of patients admitted to the ICU were also analyzed. Pre-transplant individual comorbidities were defined as per Sorror's HCT-CI. Results: There were 304 patients included with a median age of 52y (18-72y). There were 51% male and 82% Non-Hispanic white patients. The most common indication for transplant was AML (45%). Donor type was matched-unrelated, haploidentical and matched-related in 53%, 35% and 12% of cases, respectively. Majority of the patients received myeloablative conditioning (74%). The prevalence of health behaviors and comorbidities at the time of transplant is shown in Table 1. There were 39% patients with HCT-CI score of ≥3, 23% with moderate pulmonary compromise, 22% with a psychiatric disorder, 13% with severe pulmonary compromise, 13% with diabetes mellitus (DM), 10% with cardiac abnormalities and 6% with infection at the time of transplant. During the initial hospitalization, 33 (11%) patients required ICU admission, 29 (10%) required ventilator support, 33 (11%) developed multi-system organ failure, 79 (26%) developed bacterial infections and 15 (5%) developed fungal infections. The median time to neutrophil engraftment was 13 days (7-48 days). In multivariable analysis (Table 2), risk factors for ICU admission included pre-transplant infection (HR 6.50, 95% CI 1.82-23.26, p=0.004), pre-transplant DM (HR 4.14, 95% CI 1.56-10.97, p=0.004), time to neutrophil engraftment (HR 1.13, 95% CI 1.05-1.21, p=0.0007), donor type (ref: matched related donor; haplo: HR 0.24 95% CI 0.07-0.82, p=0.02) and HSCT era (ref: 2008-2010; 2010-2013: HR 0.18 95% CI 0.04-0.88, p=0.03; 2014-2016: HR 0.12 95% CI 0.03-0.4, p=0.0006). Risk factors for ventilator support included pre-transplant infection (HR 10.09, 95% CI 2.44-41.64, p=0.001), pre-transplant DM (HR 3.61, 95% CI 1.31-9.91, p=0.01), time to neutrophil engraftment (HR 1.17, 95% CI 1.11-1.23, p<0.0001) and HSCT era (ref: 2008-2010; 2010-2013: HR 0.21 95% CI 0.06-0.81, p=0.02; 2014-2016: HR 0.07 95% CI 0.02-0.31, p=0.0005). Risk factors for multi-system organ failure included pre-transplant DM (HR 4.38, 95% CI 1.64-11.74, p=0.003), time to neutrophil engraftment (HR 1.13, 95% CI 1.08-1.19, p<0.0001) and HSCT era (ref: 2008-2010; 2010-2013: HR 0.21 95% CI 0.05-0.80, p=0.003; 2014-2016: HR 0.16 95% CI 0.05-0.48, p=0.001).Risk factor for bacterial infection included HSCT era (ref: 2008-2010; 2010-2013: HR 0.30 95% CI 0.14-0.65, p=0.002; 2014-2016: HR 0.24 95% CI 0.12-0.49, p<0.0001) and for fungal infection included pre-transplant pulmonary compromise (ref: no compromise; severe pulmonary compromise HR 5.16, 95% CI 1.05-25.4, p=0.04). For patients admitted to the ICU, the 60-day and 6-month mortality was 58% and 67%, respectively. No deaths were attributed to relapse disease. The median overall survival for patients admitted to the ICU was 1.4 months (Figure 1). Conclusion: Patients with DM and infection at the time of HSCT and delayed neutrophil engraftment during transplant are at an increased risk for ICU admission, ventilator support and multi-system organ failure following allo-hsct. Patients admitted to the ICU are also at a high risk for early mortality leading to poor survival. Optimizing glycemic control and delaying transplant until resolution of infection, if the underlying disease would allow, may help improve both morbidity and mortality in transplant recipients. Figure 1 Figure 1. Disclosures Di Stasi: Syndax Pharmaceutical: Honoraria, Membership on an entity's Board of Directors or advisory committees; University of Alabama at Birmingham: Current Employment.


Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3956-3956
Author(s):  
Claudio G. Brunstein ◽  
Paul V O'Donnell ◽  
Brent R. Logan ◽  
Luciano J. Costa ◽  
Corey Cutler ◽  
...  

Abstract BACKGROUND: Our group recently reported on the results of Blood and Marrow Transplant (BMT) Clinical Trials Network (CTN) 1101 a randomized comparison between double umbilical cord blood (dUCB) and haploidentical bone marrow (haplo) with post-transplant cyclophosphamide (ptCy) in the nonmyeloablative setting that showed similar progression free survival (PFS) between the two treatment groups, but lower non-relapse mortality (NRM) and better of overall survival (OS) in the haplo arm. In this secondary analysis we sought to investigate if transplant center experience with haplo and or cord blood HCT had an impact on outcomes. PATIENTS AND METHODS: All patient randomized in BMT CTN 1101 were included. In order to determine the transplant center experience with either haplo or dUCB we queried the Center for International Blood and Marrow Transplant Research (CIBMTR) for number of transplants with each platform in the year prior to initiation of the study. Centers were then grouped as dUCB center (> 10 dUCB, n=117, 10 centers), Haplo center (>10 haplo and ≤10 dUCB, n=110, 2 centers), and ≤10 haplo and ≤10 dUCB HCTs (other center, n=140, 21 centers). Further analysis considered the alternative cut-off for haplo (> 5 vs ≤ 5) experience, and considered the outcomes based on the donor experience vs. others (e.g. dUCB > 10 vs. ≤ 10; haplo > 5 vs. ≤ 5). RESULTS: The effect of center experience on HCT outcomes shown in Figure, below . After adjusting for age, Karnofsky performance score and, disease risk index we found that there was no difference in outcomes between haplo and dUCB for centers that were experienced with dUCB or had limited to no experience with either dUCB or haplo. In contrast, in centers that were primarily experienced with haplo had better outcomes with this donor type, as compared to dUCB. The higher risk of treatment failure (relapse or death) and overall mortality in dUCB in haplo experienced centers was driven by significantly higher risk of relapse. We then considered the transplant experience with each of the donor types separately. In transplant centers that had performed > 10 dUCB, there were similar outcomes for recipients of both dUCB and haplo. Similarly, centers that had ≤ 5 haplo HCTs had no difference in outcomes between donor types suggesting an overlap with centers that had performed > 10 dUCB HCTs. Overall mortality was higher among dUCB recipients in centers that had performed ≤ 10 dUCB. Notably, the hazard ratio of non-relapse mortality favored haplo in all four donor experience type of transplant center, albeit not statistically significant. CONCLUSION: Except for dUCB recipients in centers with < 10 dUCB/year had worse overall mortality, primarily driven by relapse, the transplant center experience in the year prior to the initiation of BMT CTN 1101 had limited impact on the outcomes of this randomized clinical trial. Figure 1 Figure 1. Disclosures Brunstein: NANT: Research Funding; FATE: Research Funding; GamidaCell: Research Funding; BlueRock: Research Funding; AlloVir: Consultancy. Costa: Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Janssen: Consultancy, Honoraria, Research Funding; Sanofi: Consultancy, Honoraria, Speakers Bureau; Pfizer: Consultancy, Honoraria; BMS: Consultancy, Honoraria, Research Funding; Karyopharm: Consultancy, Honoraria. Cutler: Deciphera: Consultancy; Cimeio: Consultancy; Editas: Consultancy; Kadmon: Consultancy; Pfizer: Consultancy; Mallinckrodt: Consultancy; CareDx: Consultancy; Incyte: Consultancy; Omeros: Consultancy; Syndax: Consultancy; Mesoblast: Consultancy; Jazz: Consultancy. Horowitz: Sobi: Research Funding; Regeneron: Research Funding; Orca Biosystems: Research Funding; Tscan: Research Funding; Xenikos: Research Funding; Miltenyi Biotech: Research Funding; Stemcyte: Research Funding; Medac: Research Funding; Vor Biopharma: Research Funding; Kite/Gilead: Research Funding; Janssen: Research Funding; Pharmacyclics: Research Funding; Kiadis: Research Funding; Seattle Genetics: Research Funding; Mesoblast: Research Funding; GlaxoSmithKline: Research Funding; Sanofi: Research Funding; Pfizer, Inc: Research Funding; Omeros: Research Funding; Magenta: Consultancy, Research Funding; Jazz Pharmaceuticals: Research Funding; Vertex: Research Funding; Genentech: Research Funding; Takeda: Research Funding; Novartis: Research Funding; Shire: Research Funding; Gamida Cell: Research Funding; Daiicho Sankyo: Research Funding; CSL Behring: Research Funding; Chimerix: Research Funding; Bristol-Myers Squibb: Research Funding; bluebird bio: Research Funding; Astellas: Research Funding; Amgen: Research Funding; Allovir: Consultancy; Actinium: Research Funding. Horwitz: Gamida Cell: Research Funding. McGuirk: Novartis: Research Funding; Magenta Therapeutics: Consultancy, Honoraria, Research Funding; EcoR1 Capital: Consultancy; Pluristem Therapeutics: Research Funding; Novartis: Research Funding; Bellicum Pharmaceuticals: Research Funding; Astelllas Pharma: Research Funding; Gamida Cell: Research Funding; Fresenius Biotech: Research Funding; Allovir: Consultancy, Honoraria, Research Funding; Juno Therapeutics: Consultancy, Honoraria, Research Funding; Kite/ Gilead: Consultancy, Honoraria, Other: travel accommodations, expense, Kite a Gilead company, Research Funding, Speakers Bureau. Rezvani: US Department of Justice: Consultancy; Kaleido: Other: One-time scientific advisory board; Nohla Therapeutics: Other: One-time scientific advisory board; Pharmacyclics-Abbvie: Research Funding. Rybka: Spark Therapeutics: Consultancy; Merck: Consultancy. Vasu: Kiadis, Inc.: Research Funding; Boehringer Ingelheim: Other: Travel support; Seattle Genetics: Other: travel support; Omeros, Inc.: Membership on an entity's Board of Directors or advisory committees.


2021 ◽  
Vol 10 (21) ◽  
pp. 5168
Author(s):  
Eulàlia Solà-Porta ◽  
Dolores Redondo-Pachón ◽  
Carlos Arias-Cabrales ◽  
Diego Navazo ◽  
Anna Buxeda ◽  
...  

Early hypertransaminasemia after kidney transplantation (KT) is frequent. It has been associated with the crosstalk produced between the liver and the kidney in ischemia-reperfusion situations. However, the influence of the donor type has not been evaluated. We present a retrospective study analyzing the increase in serum aspartate aminotransferase/alanine aminotransferase (AST/ALT) during the first three months post-KT in 151 recipients who received thymoglobulin as induction therapy, either from brain-death donors (DBD, n = 75), controlled circulatory death donors (cDCD, n = 33), or uncontrolled DCD (uDCD, n = 43). Eighty-five KT recipients from DBD who received basiliximab were included as controls. From KT recipients who received thymoglobulin, 33.6/43.4% presented with an increase in AST/ALT at 72 h post-KT, respectively. Regarding donor type, the percentage of recipients who experienced 72 h post-KT hypertransaminasemia was higher in uDCD group (65.1/83.7% vs. 20.3/26% in DBD and 20.7/27.6% in cDCD, p < 0.001). Within the control group, 9.4/12.9% of patients presented with AST/ALT elevation. One month after transplant, AST/ALT values returned to baseline in all groups. The multivariate analysis showed that uDCD recipients had 6- to 12-fold higher risk of developing early post-KT hypertransaminasemia. Early post-KT hypertransaminasemia is a frequent and transient event related to the kidney donor type, being more frequent in uDCD recipients.


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