Transplantation and Cellular Therapy最新文献

{"title":"Serositis Associated with Chronic Graft-Versus-Host Disease.","authors":"Chloe Te, Taara Elahi, Kenna Samples, Lynn Onstad, Stephanie J Lee","doi":"10.1016/j.jtct.2025.07.002","DOIUrl":"10.1016/j.jtct.2025.07.002","url":null,"abstract":"<p><p>Serositis is a recognized complication associated with chronic graft-versus-host disease (cGVHD) in patients who undergo allogeneic hematopoietic cell transplantation (HCT). Although it is uncommon, serositis after HCT can have significant negative clinical impacts. There are limited data describing the patient population, incidence, risk factors, and management strategies of cGVHD-associated serositis. We retrospectively identified 50 adult patients who underwent HCT at the Fred Hutchinson Cancer Center between 1998 and 2021 and developed serositis attributed to cGVHD. Most patients developed pericardial effusions (n = 31) and/or pleural effusions (n = 38). Overall, 94% of patients with pleural effusion and 87% of patients with pericardial effusion received medical management for their serositis. Eleven patients experienced at least one recurrence of serositis. The median overall survival for all serositis types at 1-year postserositis diagnosis was 86%, and 69% for 3-year postserositis diagnosis. Serositis is a serious atypical cGVHD manifestation, and prospective data collected from a larger cohort of patients is required to better understand favorable treatment strategies and outcomes of this complication.</p>","PeriodicalId":23283,"journal":{"name":"Transplantation and Cellular Therapy","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes of Allogeneic Hematopoietic Stem Cell Transplantation in Elderly Patients with Myeloid Malignancies Over 70 Years Old: A Retrospective Analysis of the Japanese Nationwide Registry.","authors":"Sumiko Kobayashi, Hidehiro Itonaga, Shuhei Kurosawa, Masamitsu Yanada, Yukihiro Miyazaki, Yuho Najima, Jun Aoki, Naoyuki Uchida, Shigesaburo Miyakoshi, Noriko Doki, Masatsugu Tanaka, Yasufumi Uehara, Tetsuya Eto, Naoyuki Anzai, Makoto Onizuka, Masashi Sawa, Takahiro Fukuda, Noboru Asada, Yuta Katayama, Toshiro Kawakita, Makoto Yoshimitsu, Junya Kanda, Marie Ohbiki, Yoshiko Atsuta, Ken Ishiyama","doi":"10.1016/j.jtct.2025.06.032","DOIUrl":"10.1016/j.jtct.2025.06.032","url":null,"abstract":"<p><p>Although allogeneic hematopoietic stem cell transplantation (SCT) remains a potentially curative treatment option for several myeloid malignancies, despite the fact that the average age at disease onset for myeloid malignancies is approximately 70 years of age, its applicability in elderly patients is challenging. We retrospectively evaluated the outcomes of elderly SCT patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), using a nationwide Japanese registry database. We analyzed the data of 3609 patients ranging from 65 to 79 years of age with AML or MDS who underwent initial SCT between 2003 and 2022, while focusing on those 70 to 74 (n = 645) and 75 to 79 years old (n = 65). The 2-year overall survival (OS) and relapse-free survival rates for patients aged 65 to 69, 70 to 74, and 75 to 79 years were 40.9%, 38.0%, and 22.7%, and 48.4%, 47.2%, and 18.5%, respectively. Among patients categorized as low-risk at SCT, no significant differences were observed in the cumulative incidence of grade III to IV acute graft-versus-host disease (aGVHD), extensive chronic GVHD (cGVHD), non-relapse mortality, or relapse across all age groups. A multivariate analysis revealed that sex (male), diagnosis (AML), disease status (high-risk), SCT year (2003 to 2007), performance status, hematopoietic cell transplantation-specific comorbidity index (≥3), development of grade III to IV aGVHD, and extensive cGVHD significantly affected the OS. An older age (75 to 79) and the intensity of conditioning (reduced intensity) were factors indicating a trend toward an adverse prognosis. In these subgroups, significant interactions were observed between OS and SCT years, the time from diagnosis to SCT, and aGVHD. These findings suggest that SCT may be a potential curative option for selected elderly patients up to the mid-70s; however, careful patient selection and vigilant management of aGVHD are crucial factors for improving outcomes.</p>","PeriodicalId":23283,"journal":{"name":"Transplantation and Cellular Therapy","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567927","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Outcomes after Melphalan-Based Reduced Intensity Allogeneic Hematopoietic Cell Transplantation in Renal Impairment.","authors":"Tina Nguyen, Tanya Markary, Ni-Chun Tsai, Katrin Tiemann, Sally Mokhtari, Yazeed Samara, Hoda Pourhassan, Amanda Blackmon, Shukaib Arslan, Salman Otoukesh, Vaibhav Agarwal, Idoroenyi Amanam, Brian Ball, Paul Koller, Ahmed Aribi, Amandeep Salhotra, Karamjeet Sandhu, Vinod Pullarkat, Pamela Becker, Ibrahim Aldoss, Haris Ali, Forrest Stewart, Eileen Smith, Anthony Stein, Guido Marcucci, Stephen J Forman, Andrew Artz, Ryotaro Nakamura, Monzr M Al Malki","doi":"10.1016/j.jtct.2025.07.001","DOIUrl":"10.1016/j.jtct.2025.07.001","url":null,"abstract":"<p><p>Renal impairment is associated with poor outcomes following allogeneic hematopoietic cell transplantation (HCT). Although melphalan-based reduced-intensity conditioning (RIC) is demonstrated to be safe and feasible in older HCT patients, the impact of renal impairment on outcomes and toxicities following melphalan-based RIC is not well described. To evaluate how pretransplant renal function influences toxicity and survival after fludarabine/melphalan (FM) RIC and to compare measured 24-h urine creatinine clearance (UCrCl) with calculated creatinine-based renal function estimates as prognostic markers. Herein, we describe long-term outcomes of 561 HCT patients aged 55 to 74 years who received FM conditioning and tacrolimus/sirolimus as graft-versus-host disease (GVHD) prophylaxis prior to matched donor HCT, between July 2009 and December 2019. Patients were divided based on pre-HCT UCrCl: creatinine clearance (CrCl) <90 mL/min (UCrCl 2 to 3, n = 184) and CrCl ≥90 mL/min (UCrCl 0 to 1, n = 377). CrCl for all patients was also calculated by the Cockcroft-Gault and the 2021 Chronic Kidney Disease Epidemiology Collaboration equations for comparison. UCrCl 2 to 3 correlated with higher 4-year non-relapse mortality (31% versus 19%, P < .01) and lower 4-year overall survival (55% versus 62%, P = .03) without differences in relapse rates. Neither CrCl calculation method correlated with any survival endpoint. UCrCl 2 to 3 was associated with higher severity and incidence of melphalan-related adverse events. Lower UCrCl was associated with less melphalan-induced severe GVHD- and gastrointestinal toxicity-free survival (MGTFS), a composite endpoint for severe melphalan-related morbidity and mortality at day +30 post-HCT and an early correlate of long-term survival outcomes (UCrCl 2 to 3: 18% versus UCrCl 0 to 1: 31%, P < .01). Patients with poor baseline UCrCl receiving melphalan-based RIC are at risk for significant conditioning-related toxicity and GVHD and, consequently, increased mortality. MGTFS quantified the early effect of FM RIC-related toxicities on post-HCT survival in this renally impaired HCT population.</p>","PeriodicalId":23283,"journal":{"name":"Transplantation and Cellular Therapy","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567926","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessing Cognitive Function in Transplantation and CAR-T Recipients: Expert Recommendations from the Survivorship, Aging and Biobehavioral Special Interest Groups of ASTCT.","authors":"Vanessa E Kennedy, Nausheen Ahmed, Andy Artz, Neel S Bhatt, Rachel Custatis, Manuel R Espinoza-Gutarra, Shatha Farhan, Robert J Ferguson, Betty Hamilton, Hannah Katz, Debra L Kelly, Jennifer M Knight, Catherine Lee, Adam Lin, Richard Lin, Lathika Mohanraj, Pashna Munshi, Mariam Nawas, Ashley M Nelson, Silvina Odstracil, Rebecca Olin, Rachel Phelan, Kelly E Rentscher, Hélène Schoemans, Anthony Sung, Mallory R Taylor, Wiliam Wood, Carrie H Yuen, Reena V Jayani-Kosarzycki","doi":"10.1016/j.jtct.2025.06.026","DOIUrl":"10.1016/j.jtct.2025.06.026","url":null,"abstract":"<p><p>Cognitive impairment is a prevalent yet underexplored comorbidity and complication in hematopoietic stem cell transplantation (HCT) and chimeric antigen receptor (CAR) T-cell therapy. Affecting up to half of patients, cognitive impairment may include acute phases, manifesting as transplant-associated altered mentation and encephalopathy (TAME) or immune effector cell-associated neurotoxicity syndrome (ICANS), and may persist for years post-treatment as cancer-related cognitive impairment (CRCI). Such dysfunction undermines autonomy, healthcare management, work reintegration, and quality of life. This consensus review synthesizes current evidence on CRCI across the timeline of transplant and cellular therapy, organized into pre-, peri-, and post-therapy phases, with additional focus on specific populations, such as older adults and pediatric patients. It highlights gaps in understanding of cognitive impairment risks, trajectory, and impact, alongside the challenges of standardizing assessments in diverse practice settings. Key recommendations, endorsed by the American Society for Transplantation and Cellular Therapy (ASTCT) Aging, Biobehavioral Research, and Survivorship Special Interest Groups, advocate for cognitive assessment pre- and post-therapy using validated instruments, like the Montreal Cognitive Assessment (MoCA) or Blessed Orientation-Memory-Concentration Test (BOMC). We additionally recommend supplementing with patient-reported outcomes (PROs) measures for comprehensive evaluation. If cognitive impairment is identified, we recommend action items, including exclusion of alternative etiologies, reconsideration of therapy or caregiving plan, and referrals for additional evaluation and rehabilitation, among others. Practical guidance for implementation across clinical and research settings is provided, emphasizing the need for multidisciplinary strategies to address identified impairments. This work aims to establish a framework for systematic cognitive monitoring, improving patient outcomes and quality of life while guiding future research to address significant knowledge and implementation gaps.</p>","PeriodicalId":23283,"journal":{"name":"Transplantation and Cellular Therapy","volume":" ","pages":""},"PeriodicalIF":3.6,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144565266","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"On the Road to Safer CAR Therapy for B-Cell Lymphoma: Real-World Evidence","authors":"Tiara DaCosta-Clark,&nbsp;Brandon Kale,&nbsp;Fabiana Perna","doi":"10.1016/j.jtct.2025.06.009","DOIUrl":"10.1016/j.jtct.2025.06.009","url":null,"abstract":"","PeriodicalId":23283,"journal":{"name":"Transplantation and Cellular Therapy","volume":"31 7","pages":"Pages 401-404"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144549123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Cytokine Release Syndrome and Neurotoxicity Following CD19 CAR-T in B-Cell Lymphoma","authors":"Roni Shouval ,&nbsp;Christopher Strouse ,&nbsp;Soyoung Kim ,&nbsp;Temitope Oloyede ,&nbsp;Sairah Ahmed ,&nbsp;Farrukh T. Awan ,&nbsp;Danny Luan ,&nbsp;Veronika Bachanova ,&nbsp;Talha Badar ,&nbsp;Merav Bar ,&nbsp;Pere Barba ,&nbsp;Amer M. Beitinjaneh ,&nbsp;Amanda Cashen ,&nbsp;Bhagirathbhai Dholaria ,&nbsp;Mahmoud Elsawy ,&nbsp;Siddhartha Ganguly ,&nbsp;Praveen Ramakrishnan Geethakumari ,&nbsp;Uri Greenbaum ,&nbsp;Hamza Hashmi ,&nbsp;LaQuisa C. Hill ,&nbsp;Marcelo C. Pasquini","doi":"10.1016/j.jtct.2025.03.011","DOIUrl":"10.1016/j.jtct.2025.03.011","url":null,"abstract":"<div><div>Chimeric antigen receptor T cell (CAR-T) therapy is an effective treatment for relapsed-refractory large B-cell lymphoma (LBCL). However, toxicities, particularly cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), remain significant concerns. Analyze temporal trends, risk factors, and associations between these toxicities and their severity. In this registry study by the Center for International Blood and Marrow Transplant Research, we studied CRS and ICANS in 1916 LBCL patients treated with commercial CAR-T therapies (axicabtagene ciloleucel 74.9%, tisagenlecleucel 25.1%) between 2018 and 2020. Outcomes include development of CRS/ICANS, timing and severity according to ASTC grading, overall survival (OS). Risk factors were assessed using Cox proportional hazards model. Among patients developing CRS (75.2%), 11.3% had grade ≥3 CRS. Among patients developing ICANS (43.5%), 47.7% had grade ≥3 ICANS. Among patients developing CRS, severe CRS rates decreased from 14.0% in 2018 to 9.2% in 2020 (<em>P<!--> </em>&lt; .01). However, the proportion of severe ICANS in patients who developed ICANS remained statistically unchanged (41.5% in 2018 to 53.7% in 2020, <em>P<!--> </em>= .10). CRS and ICANS were correlated: 57.1% of patients with CRS also experienced ICANS, and CRS was reported in 97.5% of ICANS cases, suggesting a potential continuum between toxicities. Axicabtagene ciloleucel was associated with higher risk of any grade CRS (OR, 4.6; 95% CI, 3.65 to 5.81) and ICANS (OR, 5.85; 95% CI, 4.48 to 7.64) as well as early and severe forms of both complications. Older age, lower performance status, and elevated lactate dehydrogenase levels prior to infusion also variably predicted these toxicities. In a landmark analysis starting 30 days postinfusion, patients with severe CRS or severe ICANS had shorter OS compared to those without these toxicities. High grades of CRS improved over time likely related to earlier intervention, development of ICANS is intrinsically related with CRS. These findings underscore the need for effective strategies to mitigate these toxicities and improve CAR-T safety.</div></div>","PeriodicalId":23283,"journal":{"name":"Transplantation and Cellular Therapy","volume":"31 7","pages":"Pages 419-433"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143996473","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Belumosudil for Chronic Graft-Versus-Host Disease: Analysis of Long-Term Results from the KD025-208 and ROCKstar Studies","authors":"Stephanie J. Lee ,&nbsp;Steven Pavletic ,&nbsp;Bruce R. Blazar ,&nbsp;Yu Yao ,&nbsp;Ran Ji ,&nbsp;Kathy Marshall ,&nbsp;Corey Cutler ,&nbsp;KD025-208 and ROCKstar Study Investigators","doi":"10.1016/j.jtct.2025.04.020","DOIUrl":"10.1016/j.jtct.2025.04.020","url":null,"abstract":"<div><div>Belumosudil is an oral selective rho-associated coiled-coil–containing protein kinase-2 (ROCK2) inhibitor approved for the treatment of chronic graft-versus-host disease (cGVHD) following an allogeneic hematopoietic cell transplant in patients aged ≥12 years after failure of ≥2 prior systemic lines of therapy. The KD025-208 (NCT02841995) and KD025-213 (ROCKstar; NCT03640481) studies demonstrated that belumosudil was well tolerated, with clinically meaningful responses in patients with cGVHD. KD025-217 (NCT05305989) is a follow-up study that evaluated extended treatment with belumosudil in patients enrolled in the parent studies, KD025-208 and ROCKstar. This pooled analysis reports the long-term follow-up (overall median follow-up duration of 31.4 months) results from these studies in patients with cGVHD. The study included a total of 208 patients across 3 cohorts. Cohort 1 (<em>n</em> = 95) received belumosudil 200 mg once daily, cohort 2 (<em>n</em> = 92) received belumosudil 200 mg twice daily, and cohort 3 (<em>n</em> = 21) received belumosudil 400 mg once daily. The primary endpoint was best overall response rate (ORR). Duration of response (DOR), failure-free survival (FFS), and time to next treatment (TTNT) were also evaluated in this analysis. The best ORR in the modified intent-to-treat (mITT) population was 72%. The median DOR for the responder population was 62.3 weeks (range, 36.1 to 82.6 weeks). The median FFS in the mITT population was 15.1 months (range, 11.3 to 20.6 months). The 1- and 2-year FFS rates were 56% and 40%, respectively. The median TTNT was 22.1 months (range, 15.2 to 40.3 months), where 47% of patients received a new systemic therapy for cGVHD by 36 months. When compared with the published data, the long-term results from this pooled analysis of these two phase 2 studies demonstrated belumosudil was associated with durable responses, and it remained well tolerated with no new safety concerns.</div></div>","PeriodicalId":23283,"journal":{"name":"Transplantation and Cellular Therapy","volume":"31 7","pages":"Pages 434.e1-434.e10"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033703","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mortality Is Increased in Those with a ≥10% Reduction in Spirometry Following Allogeneic Hematopoietic Stem Cell Transplant: A Retrospective 5-Year Follow-up Study from a Single Transplant Service","authors":"Cassandra S. Thompson ,&nbsp;Megan Hogg ,&nbsp;Jonathon Lennon ,&nbsp;Yang Song ,&nbsp;Catherine Farrow ,&nbsp;David Gottlieb ,&nbsp;Peter G. Middleton","doi":"10.1016/j.jtct.2025.03.019","DOIUrl":"10.1016/j.jtct.2025.03.019","url":null,"abstract":"&lt;div&gt;&lt;div&gt;Pulmonary graft versus host disease (GVHD) is a common and serious complication of hematopoietic stem cell transplantation (HSCT). Early diagnosis is essential for rapid treatment before irreversible changes in lung function occur. The National Institutes of Health (NIH) support that a decline in forced expiratory volume in 1 second (FEV&lt;sub&gt;1&lt;/sub&gt;) of ≥10% from baseline values requires further investigation and close monitoring post HSCT. Previous research demonstrates that a 10% to 19% and ≥20% reduction in FEV&lt;sub&gt;1&lt;/sub&gt; within 6 months of transplantation is associated with higher odds of 1-year mortality. However, to the authors’ knowledge, there is no long-term follow-up data of FEV&lt;sub&gt;1&lt;/sub&gt; decline with an onset after the first 6-month period. We aimed to investigate the clinical significance of a ≥10% decrement in FEV&lt;sub&gt;1&lt;/sub&gt; measured by spirometry for predicting all-cause mortality in HSCT recipients over a period of 5 years. A comparison was made with patients who met the NIH diagnostic criteria for lung GVHD. Long-term follow-up data of patients who received an allogeneic HSCT at Westmead was audited retrospectively using a censoring period of 5 years. A decrease in lung function was defined as a change in FEV&lt;sub&gt;1&lt;/sub&gt; by ≥10% from their best value, usually at the beginning of the transplant process. Recovery was defined as a ≥10% increase in FEV&lt;sub&gt;1&lt;/sub&gt; from the patient’s maximum decline in lung function. A diagnosis of lung GVHD was made when the following criteria were met: FEV&lt;sub&gt;1&lt;/sub&gt;/forced vital capacity (FVC) ratio of &lt;0.7, and an FEV&lt;sub&gt;1&lt;/sub&gt; &lt;75% of predicted normal with ≥10% reduction over less than 2 years and evidence of gas trapping. Data from 364 patients who underwent an allogeneic HSCT between 2013 and 2019 were analyzed; 173 patients (47.7%) experienced a ≥10% reduction in FEV&lt;sub&gt;1&lt;/sub&gt; after transplantation. Ninety-five patients experienced an FEV&lt;sub&gt;1&lt;/sub&gt; decline lasting &lt;6 months and were likely to recover over half their lost lung function (median % FEV recovered = 68.7%). Seventy-eight patients experienced an FEV&lt;sub&gt;1&lt;/sub&gt; decline lasting &gt;6 months and were unlikely to recover any lost lung function (median % FEV recovered = 0%). There was a significant relationship between ≥10% FEV&lt;sub&gt;1&lt;/sub&gt; decline and death, X&lt;sup&gt;2&lt;/sup&gt;(1, 364) = 15.67, &lt;em&gt;P&lt;/em&gt; &lt; .001. All-cause mortality was doubled in those who experienced ≥10% FEV&lt;sub&gt;1&lt;/sub&gt; decline (34%) compared with those without any decline (16%). Mortality was highest in those who experienced decline without any recovery (odds ratio [OR], 2.98; 95% confidence interval [CI], 1.64-5.41). However, in the group who had a decline and then later recovered, mortality was still elevated (OR, 2.08; 95 CI, 1.17-3.69) compared with those who did not experience any FEV&lt;sub&gt;1&lt;/sub&gt; decline ≥10%. Mortality risk is elevated from the first ≥10% reduction in FEV&lt;sub&gt;1&lt;/sub&gt; and remains elevated even if FEV&lt;sub&gt;1&lt;/sub&gt; recover","PeriodicalId":23283,"journal":{"name":"Transplantation and Cellular Therapy","volume":"31 7","pages":"Pages 448.e1-448.e9"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143789230","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Randomized Clinical Trial Evaluating Lactiplantibacillus Plantarum for the Prevention of GI aGvHD: A Report From the Children’s Oncology Group (ACCL1633)","authors":"E.J. Ladas ,&nbsp;W. Collier ,&nbsp;H. Park ,&nbsp;J.J. Auletta ,&nbsp;C.C. Dvorak ,&nbsp;A. August ,&nbsp;A.J. Esbenshade ,&nbsp;M. Bhatia ,&nbsp;B.T. Fisher ,&nbsp;J.E. Levine ,&nbsp;B.H. Pollock ,&nbsp;A.C. Uhlemann ,&nbsp;M.R. Verneris ,&nbsp;M. Walters ,&nbsp;L. Yu ,&nbsp;M. Nieder","doi":"10.1016/j.jtct.2025.04.009","DOIUrl":"10.1016/j.jtct.2025.04.009","url":null,"abstract":"<div><div>Gastrointestinal (GI) acute graft-versus-host disease (aGvHD) is a leading cause of non-relapse mortality following allogeneic hematopoietic cell transplant (alloHCT). Previous studies have suggested that the intestinal microbiome may influence the risk of GI aGvHD. We performed a Phase 3, randomized, placebo-controlled clinical trial to examine the effect of <em>L. plantarum 299v (LBP 299v)</em> in preventing GI aGvHD. Participants (N = 161 evaluable participants) received <em>LBP 299v</em> or placebo from the start of conditioning therapy to 56 days post alloHCT (D56). Blood, stool, and clinical data were collected until 120 days post-transplant (D120). The D120 cumulative incidences of stages 1-4 GI aGvHD were 16% and 15% (<em>P = .</em>54), and overall grades 2-4 aGvHD were 26% and 29% (<em>P = .</em>95), <em>LBP 299v</em> and placebo groups, respectively. No patients developed <em>L. plantarum</em> bacteremia and no difference in serious adverse events was reported (<em>P</em> = 1.00). Administration of <em>LBP 299v</em> was associated with increased microbial diversity at D0 (<em>P = .</em>02) and reduced mucosal barrier injury at D7 (<em>P</em> = .02). Microbial signatures significantly differed between the groups; however, this was not associated with the investigated clinical outcomes. We conclude that administration of <em>LBP 299v</em> is safe among children and adolescents undergoing alloHCT but ineffective at preventing GI aGvHD.</div></div>","PeriodicalId":23283,"journal":{"name":"Transplantation and Cellular Therapy","volume":"31 7","pages":"Pages 452.e1-452.e12"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144048123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Masthead (Purpose and Scope)","authors":"","doi":"10.1016/S2666-6367(25)01235-7","DOIUrl":"10.1016/S2666-6367(25)01235-7","url":null,"abstract":"","PeriodicalId":23283,"journal":{"name":"Transplantation and Cellular Therapy","volume":"31 7","pages":"Pages A1-A2"},"PeriodicalIF":3.6,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144548736","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}