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3. Racial, ethnic, and socioeconomic diversity and outcomes of patients with graft-versus-host disease: a CIBMTR analysis

Author

Farhadfar, Nosha, Rashid, Nahid, Chen, Karen, DeVos, Jakob, Wang, Tao, Ballen, Karen, Beitinjaneh, Amer, Bhatt, Vijaya Raj, Hamilton, Betty K., Hematti, Peiman, Gadalla, Shahinaz M., Solomon, Scott R., El Jurdi, Najla, Lee, Catherine J., MacMillan, Margaret L., Rangarajan, Hemalatha G., Schoemans, Hélène, Sharma, Akshay, Spellman, Stephen R., Wingard, John R., and Lee, Stephanie J.

Published
2024
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4. Donor types and outcomes of transplantation in myelofibrosis: a CIBMTR study

Author

Jain, Tania, Estrada-Merly, Noel, Salas, M. Queralt, Kim, Soyoung, DeVos, Jakob, Chen, Min, Fang, Xi, Kumar, Rajat, Andrade-Campos, Marcio, Elmariah, Hany, Agrawal, Vaibhav, Aljurf, Mahmoud, Bacher, Ulrike, Badar, Talha, Badawy, Sherif M., Ballen, Karen, Beitinjaneh, Amer, Bhatt, Vijaya Raj, Bredeson, Christopher, DeFilipp, Zachariah, Dholaria, Bhagirathbhai, Farhadfar, Nosha, Farhan, Shatha, Gandhi, Arpita P., Ganguly, Siddhartha, Gergis, Usama, Grunwald, Michael R., Hamad, Nada, Hamilton, Betty K., Inamoto, Yoshihiro, Iqbal, Madiha, Jamy, Omer, Juckett, Mark, Kharfan-Dabaja, Mohamed A., Krem, Maxwell M., Lad, Deepesh P., Liesveld, Jane, Al Malki, Monzr M., Malone, Adriana K., Murthy, Hemant S., Ortí, Guillermo, Patel, Sagar S., Pawarode, Attaphol, Perales, Miguel-Angel, van der Poel, Marjolein, Ringden, Olle, Rizzieri, David A., Rovó, Alicia, Savani, Bipin N., Savoie, Mary Lynn, Seo, Sachiko, Solh, Melhem, Ustun, Celalettin, Verdonck, Leo F., Wingard, John R., Wirk, Baldeep, Bejanyan, Nelli, Jones, Richard J., Nishihori, Taiga, Oran, Betul, Nakamura, Ryotaro, Scott, Bart, Saber, Wael, and Gupta, Vikas

Published
2024
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5. Prospective Evaluation of Galactomannan and (1→3) β-d-Glucan Assays as Diagnostic Tools for Invasive Fungal Disease in Children, Adolescents, and Young Adults With Acute Myeloid Leukemia Receiving Fungal Prophylaxis.

Author

Fisher, Brian T, Westling, Ted, Boge, Craig LK, Zaoutis, Theoklis E, Dvorak, Christopher C, Nieder, Michael, Zerr, Danielle M, Wingard, John R, Villaluna, Doojduen, Esbenshade, Adam J, Alexander, Sarah, Gunn, Suphansa, Wheat, Lawrence J, and Sung, Lillian

Subjects
Clinical Trials and Supportive Activities, Rare Diseases, Infectious Diseases, Prevention, Clinical Research, Pediatric, Hematology, Evaluation of treatments and therapeutic interventions, 4.2 Evaluation of markers and technologies, 6.1 Pharmaceuticals, Detection, screening and diagnosis, Infection, Adolescent, Child, Galactose, Glucans, Humans, Invasive Fungal Infections, Leukemia, Myeloid, Acute, Mannans, Sensitivity and Specificity, Young Adult, beta-Glucans, acute myeloid leukemia, fungal biomarkers, fungal disease, pediatrics, surveillance
Abstract

BackgroundPatients receiving chemotherapy for acute myeloid leukemia (AML) are at high risk for invasive fungal disease (IFD). Diagnosis of IFD is challenging, leading to interest in fungal biomarkers. The objective was to define the utility of surveillance testing with Platelia Aspergillus galactomannan (GM) enzyme immunoassay (EIA) and Fungitell β-d-glucan (BDG) assay in children with AML receiving antifungal prophylaxis.MethodsTwice-weekly surveillance blood testing with GM EIA and BDG assay was performed during periods of neutropenia in the context of a randomized trial of children, adolescents, and young adults with AML allocated to fluconazole or caspofungin prophylaxis. Proven or probable IFD was adjudicated using blinded central reviewers. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated for Platelia and Fungitell assays alone and in combination for the outcomes of proven and probable invasive aspergillosis (IA) or invasive candidiasis (IC).ResultsAmong 471 patients enrolled, 425 participants (209 fluconazole and 216 caspofungin) contributed ≥1 blood specimen. In total, 6103 specimens were evaluated, with a median of 15 specimens per patient (range 1-43). The NPV was >99% for GM EIA and BDG assay alone and in combination. However, there were no true positive results, resulting in sensitivity and PPV for each assay of 0%.ConclusionsThe GM EIA and the BDG assay alone or in combination were not successful at detecting IA or IC during periods of neutropenia in children, adolescents, and young adults with AML receiving antifungal prophylaxis. Utilization of these assays for surveillance in this clinical setting should be discouraged.

Published
2021

6. Revision and Update of the Consensus Definitions of Invasive Fungal Disease From the European Organization for Research and Treatment of Cancer and the Mycoses Study Group Education and Research Consortium

Author

Donnelly, J Peter, Chen, Sharon C, Kauffman, Carol A, Steinbach, William J, Baddley, John W, Verweij, Paul E, Clancy, Cornelius J, Wingard, John R, Lockhart, Shawn R, Groll, Andreas H, Sorrell, Tania C, Bassetti, Matteo, Akan, Hamdi, Alexander, Barbara D, Andes, David, Azoulay, Elie, Bialek, Ralf, Bradsher, Robert W, Bretagne, Stephane, Calandra, Thierry, Caliendo, Angela M, Castagnola, Elio, Cruciani, Mario, Cuenca-Estrella, Manuel, Decker, Catherine F, Desai, Sujal R, Fisher, Brian, Harrison, Thomas, Heussel, Claus Peter, Jensen, Henrik E, Kibbler, Christopher C, Kontoyiannis, Dimitrios P, Kullberg, Bart-Jan, Lagrou, Katrien, Lamoth, Frédéric, Lehrnbecher, Thomas, Loeffler, Jurgen, Lortholary, Olivier, Maertens, Johan, Marchetti, Oscar, Marr, Kieren A, Masur, Henry, Meis, Jacques F, Morrisey, C Orla, Nucci, Marcio, Ostrosky-Zeichner, Luis, Pagano, Livio, Patterson, Thomas F, Perfect, John R, Racil, Zdenek, Roilides, Emmanuel, Ruhnke, Marcus, Prokop, Cornelia Schaefer, Shoham, Shmuel, Slavin, Monica A, Stevens, David A, Thompson, George R, Vazquez, Jose A, Viscoli, Claudio, Walsh, Thomas J, Warris, Adilia, Wheat, L Joseph, White, P Lewis, Zaoutis, Theoklis E, and Pappas, Peter G

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Cancer, Prevention, Clinical Research, Good Health and Well Being, Antifungal Agents, Consensus, Humans, Immunocompromised Host, Invasive Fungal Infections, Mycoses, Neoplasms, consensus, definitions, invasive fungal diseases, diagnosis, research, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

BackgroundInvasive fungal diseases (IFDs) remain important causes of morbidity and mortality. The consensus definitions of the Infectious Diseases Group of the European Organization for Research and Treatment of Cancer and the Mycoses Study Group have been of immense value to researchers who conduct clinical trials of antifungals, assess diagnostic tests, and undertake epidemiologic studies. However, their utility has not extended beyond patients with cancer or recipients of stem cell or solid organ transplants. With newer diagnostic techniques available, it was clear that an update of these definitions was essential.MethodsTo achieve this, 10 working groups looked closely at imaging, laboratory diagnosis, and special populations at risk of IFD. A final version of the manuscript was agreed upon after the groups' findings were presented at a scientific symposium and after a 3-month period for public comment. There were several rounds of discussion before a final version of the manuscript was approved.ResultsThere is no change in the classifications of "proven," "probable," and "possible" IFD, although the definition of "probable" has been expanded and the scope of the category "possible" has been diminished. The category of proven IFD can apply to any patient, regardless of whether the patient is immunocompromised. The probable and possible categories are proposed for immunocompromised patients only, except for endemic mycoses.ConclusionsThese updated definitions of IFDs should prove applicable in clinical, diagnostic, and epidemiologic research of a broader range of patients at high-risk.

Published
2020

8. Frequently Asked Questions on Coronavirus Disease 2019 Vaccination for Hematopoietic Cell Transplantation and Chimeric Antigen Receptor T-Cell Recipients From the American Society for Transplantation and Cellular Therapy and the American Society of Hematology

Author

Khawaja, Fareed, Papanicolaou, Genovefa, Dadwal, Sanjeet, Pergam, Steven A., Wingard, John R., Boghdadly, Zeinab El, Abidi, Maheen Z., Waghmare, Alpana, Shahid, Zainab, Michaels, Laura, Hill, Joshua A., Kamboj, Mini, Boeckh, Michael, Auletta, Jeffery J., and Chemaly, Roy F.

Published
2023
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9. Increased overall and bacterial infections following myeloablative allogeneic HCT for patients with AML in CR1

Author

Ustun, Celalettin, Kim, Soyoung, Chen, Min, Beitinjaneh, Amer M, Brown, Valerie I, Dahi, Parastoo B, Daly, Andrew, Diaz, Miguel Angel, Freytes, Cesar O, Ganguly, Siddhartha, Hashmi, Shahrukh, Hildebrandt, Gerhard C, Lazarus, Hillard M, Nishihori, Taiga, Olsson, Richard F, Page, Kristin M, Papanicolaou, Genovefa, Saad, Ayman, Seo, Sachiko, William, Basem M, Wingard, John R, Wirk, Baldeep, Yared, Jean A, Perales, Miguel-Angel, Auletta, Jeffery J, Komanduri, Krishna V, Lindemans, Caroline A, and Riches, Marcie L

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Stem Cell Research - Nonembryonic - Human, Hematology, Infectious Diseases, Transplantation, Stem Cell Research, Clinical Research, Infection, Good Health and Well Being, Adult, Bacterial Infections, Hematopoietic Stem Cell Transplantation, Humans, Infections, Leukemia, Myeloid, Acute, Myeloablative Agonists, Remission Induction, Time Factors, Transplantation Conditioning, Transplantation, Homologous, Treatment Outcome, Cardiovascular medicine and haematology
Abstract

Presumably, reduced-intensity/nonmyeloablative conditioning (RIC/NMA) for allogeneic hematopoietic cell transplantation (alloHCT) results in reduced infections compared with myeloablative conditioning (MAC) regimens; however, published evidence is limited. In this Center for International Blood and Marrow Transplant Research study, 1755 patients (aged ≥40 years) with acute myeloid leukemia in first complete remission were evaluated for infections occurring within 100 days after T-cell replete alloHCT. Patients receiving RIC/NMA (n = 777) compared with those receiving MAC (n = 978) were older and underwent transplantation more recently; however, the groups were similar regarding Karnofsky performance score, HCT-comorbidity index, and cytogenetic risk. One or more infections occurred in 1045 (59.5%) patients (MAC, 595 [61%]; RIC/NMA, 450 [58%]; P = .21) by day 100. The median time to initial infection after MAC conditioning occurred earlier (MAC, 15 days [range,

Published
2019

10. How Clean Is the Linen at My Hospital? The Mucorales on Unclean Linen Discovery Study of Large United States Transplant and Cancer Centers

Author

Sundermann, Alexander J, Clancy, Cornelius J, Pasculle, A William, Liu, Guojun, Cumbie, Richard B, Driscoll, Eileen, Ayres, Ashley, Donahue, Lisa, Pergam, Steven A, Abbo, Lilian, Andes, David R, Chandrasekar, Pranatharthi, Galdys, Alison L, Hanson, Kimberly E, Marr, Kieren A, Mayer, Jeanmarie, Mehta, Seema, Morris, Michele I, Perfect, John, Revankar, Sanjay G, Smith, Becky, Swaminathan, Sankar, Thompson, George R, Varghese, Merin, Vazquez, Jose, Whimbey, Estella, Wingard, John R, and Nguyen, M Hong

Subjects
Cancer, Bedding and Linens, Disinfection, Equipment Contamination, Humans, Infection Control, Laundry Service, Hospital, Mucorales, Textiles, United States, Mucorales, Rhizopus, Syncephalastrum, healthcare linens, microbiologic surveillance, Biological Sciences, Medical and Health Sciences, Microbiology
Abstract

Mucormycosis outbreaks have been linked to contaminated linen. We performed fungal cultures on freshly-laundered linens at 15 transplant and cancer hospitals. At 33% of hospitals, the linens were visibly unclean. At 20%, Mucorales were recovered from >10% of linens. Studies are needed to understand the clinical significance of our findings.

Published
2019

11. Reaching beyond maximum grade: progress and future directions for modernising the assessment and reporting of adverse events in haematological malignancies

Author

Thanarajasingam, Gita, Minasian, Lori M, Bhatnagar, Vishal, Cavalli, Franco, De Claro, R Angelo, Dueck, Amylou C, El-Galaly, Tarec C, Everest, Neil, Geissler, Jan, Gisselbrecht, Christian, Gormley, Nicole, Gribben, John, Horowitz, Mary, Ivy, S Percy, Jacobson, Caron A, Keating, Armand, Kluetz, Paul G, Kwong, Yok Lam, Little, Richard F, Matasar, Matthew J, Mateos, Maria-Victoria, McCullough, Kristen, Miller, Robert S, Mohty, Mohamad, Moreau, Philippe, Morton, Lindsay M, Nagai, Sumimasa, Nair, Abhilasha, Nastoupil, Loretta, Robertson, Kaye, Sidana, Surbhi, Smedby, Karin E, Sonneveld, Pieter, Tzogani, Kyriaki, van Leeuwen, Flora E, Velikova, Galina, Villa, Diego, Wingard, John R, Seymour, John F, and Habermann, Thomas M

Published
2022
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12. A phase ib clinical trial of oral ciprofloxacin and etoposide in subjects with resistant acute myeloid leukemia.

Author

Gera, Kriti, Cline, Christina, Al-Mansour, Zeina, Medvec, Andrew, Lee, Ji-Hyun, Galochkina, Zhanna, Hsu, Jack, Hiemenz, John, Farhadfar, Nosha, Dean, Erin A., Wingard, John R., and Brown, Randy

Subjects
ACUTE myeloid leukemia, CIPROFLOXACIN, ETOPOSIDE, CLINICAL trials
Abstract

A phase 1b study was conducted to evaluate the safety and feasibility of ciprofloxacin and etoposide combination treatment in subjects with relapsed and refractory acute myeloid leukemia. Eleven subjects were enrolled in the study. Utilizing the standard '3 + 3' design, escalating ciprofloxacin doses (750 mg, 1000 mg) twice daily on D1-D10 in combination with a fixed dose (200 mg) of etoposide on D2-D8 were administered. Maximum tolerated dose was determined to be 1000 mg of ciprofloxacin in combination with 200 mg of etoposide. Serious adverse events occurred in 54.5% (n = 6) subjects and 91% (n = 10) subjects reported ≥ grade 3 toxicities. Nine subjects completed treatment, one had a dose-limiting toxicity, and one withdrew. One subject achieved complete remission with a duration of 111 days and one subject achieved morphologic leukemia-free state after cycle 1. While the combination demonstrated safety and an acceptable toxicity profile, only modest hematologic and clinical benefits were observed. This trial was registered at as #NCT02773732. [ABSTRACT FROM AUTHOR]

Published
2024
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13. PCR-Based Approach Targeting Mucorales-Specific Gene Family for Diagnosis of Mucormycosis

Author

Baldin, Clara, Soliman, Sameh SM, Jeon, Heewon H, Alkhazraji, Sondus, Gebremariam, Teclegiorgis, Gu, Yiyou, Bruno, Vincent M, Cornely, Oliver A, Leather, Helen L, Sugrue, Michele W, Wingard, John R, Stevens, David A, Edwards, John E, and Ibrahim, Ashraf S

Subjects
Genetics, Emerging Infectious Diseases, Rare Diseases, Detection, screening and diagnosis, 4.1 Discovery and preclinical testing of markers and technologies, Infection, Good Health and Well Being, Animals, Aspergillosis, DNA, Fungal, Fungal Proteins, Humans, Mice, Mucorales, Mucormycosis, Polymerase Chain Reaction, Reproducibility of Results, Sensitivity and Specificity, diagnosis, CotH, Rhizopus, Mucor, Lichtheimia, Cunninghamella, Biological Sciences, Agricultural and Veterinary Sciences, Medical and Health Sciences, Microbiology
Abstract

Mucormycosis is an aggressive, life-threatening infection caused by fungi in the order Mucorales. The current diagnosis of mucormycosis relies on mycological cultures, radiology and histopathology. These methods lack sensitivity and are most definitive later in the course of infection, resulting in the prevention of timely intervention. PCR-based approaches have shown promising potential in rapidly diagnosing mucormycosis. The spore coating protein homolog encoding CotH genes are uniquely and universally present among Mucorales. Thus, CotH genes are potential targets for the rapid diagnosis of mucormycosis. We infected mice with different Mucorales known to cause human mucormycosis and investigated whether CotH could be PCR amplified from biological fluids. Uninfected mice and those with aspergillosis were used to determine the specificity of the assay. CotH was detected as early as 24 h postinfection in plasma, urine, and bronchoalveolar lavage (BAL) samples from mice infected intratracheally with Rhizopus delemar, Rhizopus oryzae, Mucor circinelloides, Lichtheimia corymbifera, or Cunninghamella bertholletiae but not from samples taken from uninfected mice or mice infected with Aspergillus fumigatus Detection of CotH from urine samples was more reliable than from plasma or BAL fluid. Using the receiver operating characteristic method, the sensitivity and the specificity of the assay were found to be 90 and 100%, respectively. Finally, CotH was PCR amplified from urine samples of patients with proven mucormycosis. Thus, PCR amplification of CotH is a promising target for the development of a reliable, sensitive, and simple method of early diagnosis of mucormycosis.

Published
2018

14. Incidence and Impact of Fungal Infections in Post-Transplantation Cyclophosphamide-Based Graft-versus-Host Disease Prophylaxis and Haploidentical Hematopoietic Cell Transplantation: A Center for International Blood and Marrow Transplant Research Analysis

Author

Papanicolaou, Genovefa A., Chen, Min, He, Naya, Martens, Michael J., Kim, Soyoung, Batista, Marjorie V., Bhatt, Neel S., Hematti, Peiman, Hill, Joshua A., Liu, Hongtao, Nathan, Sunita, Seftel, Matthew D., Sharma, Akshay, Waller, Edmund K., Wingard, John R., Young, Jo-Anne H., Dandoy, Christopher E., Perales, Miguel-Angel, Chemaly, Roy F., Riches, Marcie, and Ustun, Celalettin

Published
2024
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15. The Effect of Donor Graft Cryopreservation on Allogeneic Hematopoietic Cell Transplantation Outcomes: A Center for International Blood and Marrow Transplant Research Analysis. Implications during the COVID-19 Pandemic

Author

Hsu, Jack W., Farhadfar, Nosha, Murthy, Hemant, Logan, Brent R., Bo-Subait, Stephanie, Frey, Noelle, Goldstein, Steven C., Horowitz, Mary M., Lazarus, Hillard, Schwanke, Joshua D., Shah, Nirali N., Spellman, Stephen R., Switzer, Galen E., Devine, Steven M., Shaw, Bronwen E., and Wingard, John R.

Published
2021
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16. Impact of Pretransplantation Renal Dysfunction on Outcomes after Allogeneic Hematopoietic Cell Transplantation

Author

Farhadfar, Nosha, Dias, Ajoy, Wang, Tao, Fretham, Caitrin, Chhabra, Saurabh, Murthy, Hemant S., Broglie, Larisa, D'Souza, Anita, Gadalla, Shahinaz M., Gale, Robert Peter, Hashmi, Shahrukh, Al-Homsi, A. Samer, Hildebrandt, Gerhard C., Hematti, Peiman, Rizzieri, David, Chee, Lynette, Lazarus, Hillard M., Bredeson, Christopher, Jaimes, Edgar A., Beitinjaneh, Amer, Bashey, Asad, Prestidge, Tim, Krem, Maxwell M., Marks, David I., Benoit, Stefanie, Yared, Jean A., Nishihori, Taiga, Olsson, Richard F., Freytes, Cesar O., Stadtmauer, Edward, Savani, Bipin N., Sorror, Mohamed L., Ganguly, Siddhartha, Wingard, John R., and Pasquini, Marcelo

Published
2021
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17. A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients

Author

Ljungman, Per, Bermudez, Arancha, Logan, Aaron C., Kharfan-Dabaja, Mohamed A., Chevallier, Patrice, Martino, Rodrigo, Wulf, Gerald, Selleslag, Dominik, Kakihana, Kazuhiko, Langston, Amelia, Lee, Dong-Gun, Solano, Carlos, Okamoto, Shinichiro, Smith, Larry R., Boeckh, Michael, Wingard, John R., Cywin, Beth, Fredericks, Christine, Lademacher, Christopher, Wang, Xuegong, Young, James, and Maertens, Johan

Published
2021
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18. National Institutes of Health Hematopoietic Cell Transplantation Late Effects Initiative: The Immune Dysregulation and Pathobiology Working Group Report

Author

Gea-Banacloche, Juan, Komanduri, Krishna V, Carpenter, Paul, Paczesny, Sophie, Sarantopoulos, Stefanie, Young, Jo-Anne, Kassar, Nahed El, Le, Robert Q, Schultz, Kirk R, Griffith, Linda M, Savani, Bipin N, and Wingard, John R

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Immunology, Transplantation, Clinical Research, Vaccine Related, Rare Diseases, Prevention, Emerging Infectious Diseases, Infectious Diseases, Immunization, Infection, Inflammatory and immune system, Good Health and Well Being, Hematopoietic Stem Cell Transplantation, Humans, Immune Reconstitution, Infections, Long Term Adverse Effects, National Institutes of Health (U.S.), United States, Immune reconstitution, Intravenous immunoglobulin, Late infections, Clinical Sciences, Cardiovascular medicine and haematology
Abstract

Immune reconstitution after hematopoietic stem cell transplantation (HCT) beyond 1 year is not completely understood. Many transplant recipients who are free of graft-versus-host disease (GVHD) and not receiving any immunosuppression more than 1 year after transplantation seem to be able to mount appropriate immune responses to common pathogens and respond adequately to immunizations. However, 2 large registry studies over the last 2 decades seem to indicate that infection is a significant cause of late mortality in some patients, even in the absence of concomitant GVHD. Research on this topic is particularly challenging for several reasons. First, there are not enough long-term follow-up clinics able to measure even basic immune parameters late after HCT. Second, the correlation between laboratory measurements of immune function and infections is not well known. Third, accurate documentation of infectious episodes is notoriously difficult. Finally, it is unclear what measures can be implemented to improve the immune response in a clinically relevant way. A combination of long-term multicenter prospective studies that collect detailed infectious data and store samples as well as a national or multinational registry of clinically significant infections (eg, vaccine-preventable severe infections, opportunistic infections) could begin to address our knowledge gaps. Obtaining samples for laboratory evaluation of the immune system should be both calendar and eventdriven. Attention to detail and standardization of practices regarding prophylaxis, diagnosis, and definitions of infections would be of paramount importance to obtain clean reliable data. Laboratory studies should specifically address the neogenesis, maturation, and exhaustion of the adaptive immune system and, in particular, how these are influenced by persistent alloreactivity, inflammation, and viral infection. Ideally, some of these long-term prospective studies would collect information on long-term changes in the gut microbiome and their influence on immunity. Regarding enhancement of immune function, prospective measurement of the response to vaccines late after HCT in a variety of clinical settings should be undertaken to better understand the benefits as well as the limitations of immunizations. The role of intravenous immunoglobulin is still not well defined, and studies to address it should be encouraged.

Published
2017

19. Expansion of Human Tregs from Cryopreserved Umbilical Cord Blood for GMP-Compliant Autologous Adoptive Cell Transfer Therapy

Author

Seay, Howard R, Putnam, Amy L, Cserny, Judit, Posgai, Amanda L, Rosenau, Emma H, Wingard, John R, Girard, Kate F, Kraus, Morey, Lares, Angela P, Brown, Heather L, Brown, Katherine S, Balavage, Kristi T, Peters, Leeana D, Bushdorf, Ashley N, Atkinson, Mark A, Bluestone, Jeffrey A, Haller, Michael J, and Brusko, Todd M

Subjects
Biomedical and Clinical Sciences, Immunology, Stem Cell Research - Umbilical Cord Blood/ Placenta, Stem Cell Research - Umbilical Cord Blood/ Placenta - Human, Prevention, Immunization, Stem Cell Research - Nonembryonic - Human, Vaccine Related, Transplantation, Autoimmune Disease, Stem Cell Research, 5.2 Cellular and gene therapies, Development of treatments and therapeutic interventions, Inflammatory and immune system, T cell receptor, adoptive cell transfer, autoimmunity, cord blood, good manufacturing practices, regulatory T cell, type 1 diabetes, Medical biotechnology
Abstract

Umbilical cord blood is a traditional and convenient source of cells for hematopoietic stem cell transplantation. Thymic regulatory T cells (Tregs) are also present in cord blood, and there is growing interest in the use of autologous Tregs to provide a low-risk, fully human leukocyte antigen (HLA)-matched cell product for treating autoimmune diseases, such as type 1 diabetes. Here, we describe a good manufacturing practice (GMP)-compatible Treg expansion protocol using fluorescence-activated cell sorting, resulting in a mean 2,092-fold expansion of Tregs over a 16-day culture for a median yield of 1.26 × 109 Tregs from single-donor cryopreserved units. The resulting Tregs passed prior clinical trial release criteria for Treg purity and sterility, including additional rigorous assessments of FOXP3 and Helios expression and epigenetic analysis of the FOXP3 Treg-specific demethylated region (TSDR). Compared with expanded adult peripheral blood Tregs, expanded cord blood Tregs remained more naive, as assessed by continued expression of CD45RA, produced reduced IFN-γ following activation, and effectively inhibited responder T cell proliferation. Immunosequencing of the T cell receptor revealed a remarkably diverse receptor repertoire within cord blood Tregs that was maintained following in vitro expansion. These data support the feasibility of generating GMP-compliant Tregs from cord blood for adoptive cell transfer therapies and highlight potential advantages in terms of safety, phenotypic stability, autoantigen specificity, and tissue distribution.

Published
2017

20. Gilteritinib as Post-Transplant Maintenance for Acute Myeloid Leukemia With Internal Tandem Duplication Mutation of FLT3

Author

Levis, M, Hamadani, M, Logan, B, Jones, R, Singh, A, Litzow, M, Wingard, J, Papadopoulos, E, Perl, A, Soiffer, R, Ustun, C, Ueda Oshima, M, Uy, G, Waller, E, Vasu, S, Solh, M, Mishra, A, Muffly, L, Kim, H, Mikesch, J, Najima, Y, Onozawa, M, Thomson, K, Nagler, A, Wei, A, Marcucci, G, Geller, N, Hasabou, N, Delgado, D, Rosales, M, Hill, J, Gill, S, Nuthethi, R, King, D, Wittsack, H, Mendizabal, A, Devine, S, Horowitz, M, Chen, Y, Agura, E, Altman, J, Anagnostopoulos, A, Anand, S, Artz, A, Aulitzky, W, Balderman, S, Ballen, K, Becker, M, Beguin, Y, Berkahn, L, Berneman, Z, Bhatt, V, Bilmon, I, Bonifazi, F, Briggs, A, Bruno, B, Brunstein, C, Byrne, M, Byrne, J, Cabrero, M, Cairoli, R, Carrum, G, Cerny, J, Cheong, J, Ciceri, F, Colorado, M, Cook, R, Couriel, D, Craddock, C, Damon, L, Deol, A, Desbrosses, Y, Di Grazia, C, Di Stasi, A, Dias, A, Dorritie, K, Essell, J, Eto, T, Farag, S, Forcade, E, Frankfurt, O, Fujiwara, S, Fukuda, T, Fukushima, K, Furst, S, Goto, T, Hall, A, Hatta, S, Hicheri, Y, Horwitz, M, Hou, H, How, J, Howard, D, Hsu, W, Huynh, A, Irvine, D, Ishikawa, T, Jamieson, K, Jedrzejczak, W, Jethava, Y, Jimenez, A, Jung, C, Kanda, J, Karakasis, D, Kato, J, Kekre, N, Khera, N, Klein, A, Kobbe, G, Kornblit, B, Kota, V, Lachance, S, Leber, B, Lee, C, Lee, J, Lin, T, Liu, T, Martelli, M, Martinez, C, Matsuoka, K, Mccarty, J, Mendez, L, Michelis, F, Mineishi, S, Mohty, M, Moors, I, Motyckova, G, Mueller, L, Nakamae, H, Nakano, N, Nathan, S, Nicholson, E, Norkin, M, Ogawa, Y, Olesen, G, Oluwole, O, Pantin, J, Paulson, K, Pemberton, L, Perera, T, Piatkowska-Jakubas, B, Poire, X, Protheroe, R, Rambaldi, A, Ritchie, D, Ross, K, Rubio, M, Santarone, S, Sanz Caballer, J, Sawa, M, Schaar, D, Scheid, C, Schriber, J, Seropian, S, Shah, N, Shore, T, Gil, J, Sobecks, R, Socie, G, Sprague, K, Spyridonidis, A, Stelljes, M, Stiff, P, Stuart, R, Tanaka, M, Tandra, A, Tholouli, E, Thomas, X, Tiribelli, M, Tomlinson, B, Tsirigotis, P, Tzachanis, D, Uchida, N, Ueda, M, Valcarcel Ferreiras, D, Wagner, E, Watson, A, Weisdorf, D, Wolschke, C, Wrobel, T, Yakoub-Agha, I, Yamauchi, T, Yared, J, Yeh, S, Yoon, S, Yoshihara, S, Null, N, Levis, Mark J., Hamadani, Mehdi, Logan, Brent, Jones, Richard J., Singh, Anurag K., Litzow, Mark, Wingard, John R., Papadopoulos, Esperanza B., Perl, Alexander E., Soiffer, Robert J., Ustun, Celalettin, Ueda Oshima, Masumi, Uy, Geoffrey L., Waller, Edmund K., Vasu, Sumithra, Solh, Melhem, Mishra, Asmita, Muffly, Lori, Kim, Hee-Je, Mikesch, Jan-Henrik, Najima, Yuho, Onozawa, Masahiro, Thomson, Kirsty, Nagler, Arnon, Wei, Andrew H., Marcucci, Guido, Geller, Nancy L., Hasabou, Nahla, Delgado, David, Rosales, Matt, Hill, Jason, Gill, Stanley C., Nuthethi, Rishita, King, Denise, Wittsack, Heather, Mendizabal, Adam, Devine, Steven M., Horowitz, Mary M., Chen, Yi-Bin, Agura, Ed, Altman, Jessica, Anagnostopoulos, Achiles, Anand, Sarah, Artz, Andrew, Aulitzky, Walter, Balderman, Sophia, Ballen, Karen, Becker, Michael, Beguin, Yves, Berkahn, Leanne, Berneman, Zwi, Bhatt, Vijaya, Bilmon, Ian, Bonifazi, Francesca, Briggs, Adrienne, Bruno, Benedetto, Brunstein, Claudio, Byrne, Michael, Byrne, Jenny, Cabrero, Monica, Cairoli, Roberto, Carrum, George, Cerny, Jan, Cheong, June-Won, Ciceri, Fabio, Colorado, Mercedes, Cook, Rachel, Couriel, Daniel, Craddock, Charles, Damon, Lloyd, Deol, Abhinav, Desbrosses, Yohan, Devine, Steve, Di Grazia, Carmela, Di Stasi, Antonio, Dias, Ajoy, Dorritie, Kathy, Essell, James, Eto, Tetsuya, Farag, Sherif, Forcade, Edouard, Frankfurt, Olga, Fujiwara, Shinichiro, Fukuda, Takahiro, Fukushima, Kentaro, Furst, Sabine, Goto, Tatsunori, Hall, Aric, Hatta, Shunsuke, Hicheri, Yosr, Horwitz, Mitchell, Hou, Hsin-An, How, Jonathan, Howard, Dianna, Hsu, Wei-Hsun (Blake), Huynh, Anne, Irvine, David, Ishikawa, Takayuki, Jamieson, Katarzyna, Jedrzejczak, Wieslaw, Jethava, Yogesh, Jimenez, Antonio, Jung, Chul Won, Kanda, Junya, Karakasis, Dimitrios, Kato, Jun, Kekre, Natasha, Khera, Nandita, Klein, Andreas, Kobbe, Guido, Kornblit, Brian, Kota, Vamsi, Lachance, Silvy, Leber, Brian, Lee, Catherine, Lee, Je Hwan, Lin, Tung-Liang, Liu, Ta-Chih, Martelli, Maurizio, Martinez, Carmen, Matsuoka, Kenichi, McCarty, John, Mendez, Lourdes, Michelis, Fotios, Mineishi, Shin, Mohty, Mohamad, Moors, Ine, Motyckova, Gabriela, Mueller, Lutz, Nakamae, Hirohisa, Nakano, Nobuaki, Nathan, Sunita, Nicholson, Emma, Norkin, Maxim, Ogawa, Yoshiaki, Olesen, Gitte, Oluwole, Olalekan, Pantin, Jeremy, Paulson, Kristjan, Pemberton, Lucy, Perera, Travis, Piatkowska-Jakubas, Beata, Poire, Xavier, Protheroe, Rachel, Rambaldi, Alessandro, Ritchie, David, Ross, Kelly, Rubio, Marie-Therese, Santarone, Stella, Sanz Caballer, Jaime, Sawa, Masashi, Schaar, Dale, Scheid, Christoph, Schriber, Jeffrey, Seropian, Stuart, Shah, Nilay, Shah, Nirav, Shore, Tsiporah, Gil, Jorge Sierra, Singh, Anurag, Sobecks, Ronald, Socie, Gerard, Soiffer, Robert, Sprague, Kellie, Spyridonidis, Alexandros, Stelljes, Matthias, Stiff, Patrick, Stuart, Robert, Tanaka, Masatsugu, Tandra, Anand, Tholouli, Eleni, Thomas, Xavier, Tiribelli, Mario, Tomlinson, Benjamin, Tsirigotis, Panagiotis, Tzachanis, Dimitrios, Uchida, Naoyuki, Ueda, Masumi, Valcarcel Ferreiras, David, Wagner, Eva, Watson, Anne-Marie, Weisdorf, Daniel, Wolschke, Christine, Wrobel, Tomasz, Yakoub-Agha, Ibrahim, Yamauchi, Takuji, Yared, Jean, Yeh, Su-Peng, Yoon, Sung-Soo, Yoshihara, Satoshi, null, null, Levis, M, Hamadani, M, Logan, B, Jones, R, Singh, A, Litzow, M, Wingard, J, Papadopoulos, E, Perl, A, Soiffer, R, Ustun, C, Ueda Oshima, M, Uy, G, Waller, E, Vasu, S, Solh, M, Mishra, A, Muffly, L, Kim, H, Mikesch, J, Najima, Y, Onozawa, M, Thomson, K, Nagler, A, Wei, A, Marcucci, G, Geller, N, Hasabou, N, Delgado, D, Rosales, M, Hill, J, Gill, S, Nuthethi, R, King, D, Wittsack, H, Mendizabal, A, Devine, S, Horowitz, M, Chen, Y, Agura, E, Altman, J, Anagnostopoulos, A, Anand, S, Artz, A, Aulitzky, W, Balderman, S, Ballen, K, Becker, M, Beguin, Y, Berkahn, L, Berneman, Z, Bhatt, V, Bilmon, I, Bonifazi, F, Briggs, A, Bruno, B, Brunstein, C, Byrne, M, Byrne, J, Cabrero, M, Cairoli, R, Carrum, G, Cerny, J, Cheong, J, Ciceri, F, Colorado, M, Cook, R, Couriel, D, Craddock, C, Damon, L, Deol, A, Desbrosses, Y, Di Grazia, C, Di Stasi, A, Dias, A, Dorritie, K, Essell, J, Eto, T, Farag, S, Forcade, E, Frankfurt, O, Fujiwara, S, Fukuda, T, Fukushima, K, Furst, S, Goto, T, Hall, A, Hatta, S, Hicheri, Y, Horwitz, M, Hou, H, How, J, Howard, D, Hsu, W, Huynh, A, Irvine, D, Ishikawa, T, Jamieson, K, Jedrzejczak, W, Jethava, Y, Jimenez, A, Jung, C, Kanda, J, Karakasis, D, Kato, J, Kekre, N, Khera, N, Klein, A, Kobbe, G, Kornblit, B, Kota, V, Lachance, S, Leber, B, Lee, C, Lee, J, Lin, T, Liu, T, Martelli, M, Martinez, C, Matsuoka, K, Mccarty, J, Mendez, L, Michelis, F, Mineishi, S, Mohty, M, Moors, I, Motyckova, G, Mueller, L, Nakamae, H, Nakano, N, Nathan, S, Nicholson, E, Norkin, M, Ogawa, Y, Olesen, G, Oluwole, O, Pantin, J, Paulson, K, Pemberton, L, Perera, T, Piatkowska-Jakubas, B, Poire, X, Protheroe, R, Rambaldi, A, Ritchie, D, Ross, K, Rubio, M, Santarone, S, Sanz Caballer, J, Sawa, M, Schaar, D, Scheid, C, Schriber, J, Seropian, S, Shah, N, Shore, T, Gil, J, Sobecks, R, Socie, G, Sprague, K, Spyridonidis, A, Stelljes, M, Stiff, P, Stuart, R, Tanaka, M, Tandra, A, Tholouli, E, Thomas, X, Tiribelli, M, Tomlinson, B, Tsirigotis, P, Tzachanis, D, Uchida, N, Ueda, M, Valcarcel Ferreiras, D, Wagner, E, Watson, A, Weisdorf, D, Wolschke, C, Wrobel, T, Yakoub-Agha, I, Yamauchi, T, Yared, J, Yeh, S, Yoon, S, Yoshihara, S, Null, N, Levis, Mark J., Hamadani, Mehdi, Logan, Brent, Jones, Richard J., Singh, Anurag K., Litzow, Mark, Wingard, John R., Papadopoulos, Esperanza B., Perl, Alexander E., Soiffer, Robert J., Ustun, Celalettin, Ueda Oshima, Masumi, Uy, Geoffrey L., Waller, Edmund K., Vasu, Sumithra, Solh, Melhem, Mishra, Asmita, Muffly, Lori, Kim, Hee-Je, Mikesch, Jan-Henrik, Najima, Yuho, Onozawa, Masahiro, Thomson, Kirsty, Nagler, Arnon, Wei, Andrew H., Marcucci, Guido, Geller, Nancy L., Hasabou, Nahla, Delgado, David, Rosales, Matt, Hill, Jason, Gill, Stanley C., Nuthethi, Rishita, King, Denise, Wittsack, Heather, Mendizabal, Adam, Devine, Steven M., Horowitz, Mary M., Chen, Yi-Bin, Agura, Ed, Altman, Jessica, Anagnostopoulos, Achiles, Anand, Sarah, Artz, Andrew, Aulitzky, Walter, Balderman, Sophia, Ballen, Karen, Becker, Michael, Beguin, Yves, Berkahn, Leanne, Berneman, Zwi, Bhatt, Vijaya, Bilmon, Ian, Bonifazi, Francesca, Briggs, Adrienne, Bruno, Benedetto, Brunstein, Claudio, Byrne, Michael, Byrne, Jenny, Cabrero, Monica, Cairoli, Roberto, Carrum, George, Cerny, Jan, Cheong, June-Won, Ciceri, Fabio, Colorado, Mercedes, Cook, Rachel, Couriel, Daniel, Craddock, Charles, Damon, Lloyd, Deol, Abhinav, Desbrosses, Yohan, Devine, Steve, Di Grazia, Carmela, Di Stasi, Antonio, Dias, Ajoy, Dorritie, Kathy, Essell, James, Eto, Tetsuya, Farag, Sherif, Forcade, Edouard, Frankfurt, Olga, Fujiwara, Shinichiro, Fukuda, Takahiro, Fukushima, Kentaro, Furst, Sabine, Goto, Tatsunori, Hall, Aric, Hatta, Shunsuke, Hicheri, Yosr, Horwitz, Mitchell, Hou, Hsin-An, How, Jonathan, Howard, Dianna, Hsu, Wei-Hsun (Blake), Huynh, Anne, Irvine, David, Ishikawa, Takayuki, Jamieson, Katarzyna, Jedrzejczak, Wieslaw, Jethava, Yogesh, Jimenez, Antonio, Jung, Chul Won, Kanda, Junya, Karakasis, Dimitrios, Kato, Jun, Kekre, Natasha, Khera, Nandita, Klein, Andreas, Kobbe, Guido, Kornblit, Brian, Kota, Vamsi, Lachance, Silvy, Leber, Brian, Lee, Catherine, Lee, Je Hwan, Lin, Tung-Liang, Liu, Ta-Chih, Martelli, Maurizio, Martinez, Carmen, Matsuoka, Kenichi, McCarty, John, Mendez, Lourdes, Michelis, Fotios, Mineishi, Shin, Mohty, Mohamad, Moors, Ine, Motyckova, Gabriela, Mueller, Lutz, Nakamae, Hirohisa, Nakano, Nobuaki, Nathan, Sunita, Nicholson, Emma, Norkin, Maxim, Ogawa, Yoshiaki, Olesen, Gitte, Oluwole, Olalekan, Pantin, Jeremy, Paulson, Kristjan, Pemberton, Lucy, Perera, Travis, Piatkowska-Jakubas, Beata, Poire, Xavier, Protheroe, Rachel, Rambaldi, Alessandro, Ritchie, David, Ross, Kelly, Rubio, Marie-Therese, Santarone, Stella, Sanz Caballer, Jaime, Sawa, Masashi, Schaar, Dale, Scheid, Christoph, Schriber, Jeffrey, Seropian, Stuart, Shah, Nilay, Shah, Nirav, Shore, Tsiporah, Gil, Jorge Sierra, Singh, Anurag, Sobecks, Ronald, Socie, Gerard, Soiffer, Robert, Sprague, Kellie, Spyridonidis, Alexandros, Stelljes, Matthias, Stiff, Patrick, Stuart, Robert, Tanaka, Masatsugu, Tandra, Anand, Tholouli, Eleni, Thomas, Xavier, Tiribelli, Mario, Tomlinson, Benjamin, Tsirigotis, Panagiotis, Tzachanis, Dimitrios, Uchida, Naoyuki, Ueda, Masumi, Valcarcel Ferreiras, David, Wagner, Eva, Watson, Anne-Marie, Weisdorf, Daniel, Wolschke, Christine, Wrobel, Tomasz, Yakoub-Agha, Ibrahim, Yamauchi, Takuji, Yared, Jean, Yeh, Su-Peng, Yoon, Sung-Soo, Yoshihara, Satoshi, and null, null

Abstract

Purpose: Allogeneic hematopoietic cell transplantation (HCT) improves outcomes for patients with acute myeloid leukemia (AML) harboring an internal tandem duplication mutation of FLT3 (FLT3-ITD) AML. These patients are routinely treated with a FLT3 inhibitor after HCT, but there is limited evidence to support this. Accordingly, we conducted a randomized trial of post-HCT maintenance with the FLT3 inhibitor gilteritinib (ClinicalTrials.gov identifier: NCT02997202) to determine if all such patients benefit or if detection of measurable residual disease (MRD) could identify those who might benefit. Methods: Adults with FLT3-ITD AML in first remission underwent HCT and were randomly assigned to placebo or 120 mg once daily gilteritinib for 24 months after HCT. The primary end point was relapse-free survival (RFS). Secondary end points included overall survival (OS) and the effect of MRD pre- and post-HCT on RFS and OS. Results: Three hundred fifty-six participants were randomly assigned post-HCT to receive gilteritinib or placebo. Although RFS was higher in the gilteritinib arm, the difference was not statistically significant (hazard ratio [HR], 0.679 [95% CI, 0.459 to 1.005]; two-sided P = .0518). However, 50.5% of participants had MRD detectable pre- or post-HCT, and, in a prespecified subgroup analysis, gilteritinib was beneficial in this population (HR, 0.515 [95% CI, 0.316 to 0.838]; P = .0065). Those without detectable MRD showed no benefit (HR, 1.213 [95% CI, 0.616 to 2.387]; P = .575). Conclusion: Although the overall improvement in RFS was not statistically significant, RFS was higher for participants with detectable FLT3-ITD MRD pre- or post-HCT who received gilteritinib treatment. To our knowledge, these data are among the first to support the effectiveness of MRD-based post-HCT therapy.

Published
2024

21. Racial and Socioeconomic Disparities in Long-Term Outcomes in ≥1 Year Allogeneic Hematopoietic Cell Transplantation Survivors: A CIBMTR Analysis

Author

Blue, Brandon J., Brazauskas, Ruta, Chen, Karen, Patel, Jinalben, Zeidan, Amer M., Steinberg, Amir, Ballen, Karen, Kwok, Janette, Rotz, Seth J., Perez, Miguel Angel Diaz, Kelkar, Amar H., Ganguly, Siddhartha, Wingard, John R., Lad, Deepesh, Sharma, Akshay, Badawy, Sherif M., Lazarus, Hillard M., Hashem, Hasan, Szwajcer, David, Knight, Jennifer M., Bhatt, Neel S., Page, Kristin, Beattie, Sara, Arai, Yasuyuki, Liu, Hongtao, Arnold, Staci D., Freytes, César O., Abid, Muhammad Bilal, Beitinjaneh, Amer, Farhadfar, Nosha, Wirk, Baldeep, Winestone, Lena E., Agrawal, Vaibhav, Preussler, Jaime M., Seo, Sachiko, Hashmi, Shahrukh, Lehmann, Leslie, Wood, William A., Rangarajan, Hemalatha G., Saber, Wael, and Majhail, Navneet S.

Published
2023
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22. Real-World Issues and Potential Solutions in Hematopoietic Cell Transplantation during the COVID-19 Pandemic: Perspectives from the Worldwide Network for Blood and Marrow Transplantation and Center for International Blood and Marrow Transplant Research Health Services and International Studies Committee

Author

Algwaiz, Ghada, Aljurf, Mahmoud, Koh, Mickey, Horowitz, Mary M., Ljungman, Per, Weisdorf, Daniel, Saber, Wael, Kodera, Yoshihisa, Szer, Jeff, Jawdat, Dunia, Wood, William A., Brazauskas, Ruta, Lehmann, Leslie, Pasquini, Marcelo C., Seber, Adriana, Lu, Pei Hua, Atsuta, Yoshiko, Riches, Marcie, Perales, Miguel-Angel, Worel, Nina, Okamoto, Shinichiro, Srivastava, Alok, Chemaly, Roy F., Cordonnier, Catherine, Dandoy, Christopher E., Wingard, John R., Kharfan-Dabaja, Mohamed A., Hamadani, Mehdi, Majhail, Navneet S., Waghmare, Alpana A., Chao, Nelson, Kröger, Nicolaus, Shaw, Bronwen, Mohty, Mohamad, Niederwieser, Dietger, Greinix, Hildegard, and Hashmi, Shahrukh K.

Published
2020
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27. Collection of Peripheral Blood Progenitor Cells in 1 Day Is Associated with Decreased Donor Toxicity Compared to 2 Days in Unrelated Donors

Author

Hsu, Jack W., Shaw, Bronwen E., Kim, Soyoung, Logan, Brent R., Sees, Jennifer A., Confer, Dennis L., Pulsipher, Michael A., Shah, Nirali, Switzer, Galen E., Abidi, Muneer H., Ahmed, Ibrahim A., Anderlini, Paulo N., Bredeson, Christopher, Chhabra, Saurabh, Dandoy, Christopher E., Diaz, Miguel Angel, Farhadfar, Nosha, Ganguly, Siddhartha, Gergis, Usama, Hale, Gregory A., Hematti, Peiman, Kamble, Rammurti T., Kasow, Kimberly A., Lazarus, Hillard M., Liesveld, Jane L., Murthy, Hemant S., Olsson, Richard F., Savani, Bipin N., Schears, Raquel, Seo, Sachiko, Solh, Melhern, Spitzer, Thomas, Steinberg, Amir, Sugrue, Michele, Warkentin, Phyllis, and Wingard, John R.

Published
2020
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31. Infection Rates among Acute Leukemia Patients Receiving Alternative Donor Hematopoietic Cell Transplantation

Author

Ballen, Karen, Ahn, Kwang Woo, Chen, Min, Abdel-Azim, Hisham, Ahmed, Ibrahim, Aljurf, Mahmoud, Antin, Joseph, Bhatt, Ami S, Boeckh, Michael, Chen, George, Dandoy, Christopher, George, Biju, Laughlin, Mary J, Lazarus, Hillard M, MacMillan, Margaret L, Margolis, David A, Marks, David I, Norkin, Maxim, Rosenthal, Joseph, Saad, Ayman, Savani, Bipin, Schouten, Harry C, Storek, Jan, Szabolcs, Paul, Ustun, Celalettin, Verneris, Michael R, Waller, Edmund K, Weisdorf, Daniel J, Williams, Kirsten M, Wingard, John R, Wirk, Baldeep, Wolfs, Tom, Young, Jo-Anne H, Auletta, Jeffrey, Komanduri, Krishna V, Lindemans, Caroline, and Riches, Marcie L

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Immunology, Rare Diseases, Stem Cell Research, Infectious Diseases, Clinical Research, Regenerative Medicine, Transplantation, Hematology, Stem Cell Research - Nonembryonic - Human, 2.2 Factors relating to the physical environment, Aetiology, Infection, Good Health and Well Being, Acute Disease, Adolescent, Adult, Aged, Cord Blood Stem Cell Transplantation, Female, Hematopoietic Stem Cell Transplantation, Histocompatibility, Humans, Incidence, Infections, Leukemia, Male, Middle Aged, Retrospective Studies, Survival Analysis, Unrelated Donors, Young Adult, Umbilical cord blood, Clinical Sciences, Cardiovascular medicine and haematology
Abstract

Alternative graft sources (umbilical cord blood [UCB], matched unrelated donors [MUD], or mismatched unrelated donors [MMUD]) enable patients without a matched sibling donor to receive potentially curative hematopoietic cell transplantation (HCT). Retrospective studies demonstrate comparable outcomes among different graft sources. However, the risk and types of infections have not been compared among graft sources. Such information may influence the choice of a particular graft source. We compared the incidence of bacterial, viral, and fungal infections in 1781 adults with acute leukemia who received alternative donor HCT (UCB, n= 568; MUD, n = 930; MMUD, n = 283) between 2008 and 2011. The incidences of bacterial infection at 1 year were 72%, 59%, and 65% (P

Published
2016

32. Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America

Author

Patterson, Thomas F, Thompson, George R, Denning, David W, Fishman, Jay A, Hadley, Susan, Herbrecht, Raoul, Kontoyiannis, Dimitrios P, Marr, Kieren A, Morrison, Vicki A, Nguyen, M Hong, Segal, Brahm H, Steinbach, William J, Stevens, David A, Walsh, Thomas J, Wingard, John R, Young, Jo-Anne H, and Bennett, John E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Rare Diseases, Clinical Research, Management of diseases and conditions, 7.3 Management and decision making, Good Health and Well Being, Amphotericin B, Antifungal Agents, Aspergillosis, Azoles, Echinocandins, Humans, Infectious Disease Medicine, Societies, Medical, United States, aspergillosis, invasive aspergillosis, allergic aspergillosis, chronic aspergillosis, fungal diagnostics, azoles, echniocandins, amphotericin, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.

Published
2016

33. Executive Summary: Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America

Author

Patterson, Thomas F, Thompson, George R, Denning, David W, Fishman, Jay A, Hadley, Susan, Herbrecht, Raoul, Kontoyiannis, Dimitrios P, Marr, Kieren A, Morrison, Vicki A, Nguyen, M Hong, Segal, Brahm H, Steinbach, William J, Stevens, David A, Walsh, Thomas J, Wingard, John R, Young, Jo-Anne H, and Bennett, John E

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Rare Diseases, Clinical Research, 7.3 Management and decision making, Management of diseases and conditions, Good Health and Well Being, Amphotericin B, Antifungal Agents, Aspergillosis, Azoles, Echinocandins, Humans, Infectious Disease Medicine, Practice Guidelines as Topic, Societies, Medical, United States, aspergillosis, invasive aspergillosis, allergic aspergillosis, chronic aspergillosis, fungal diagnostics, azoles, echniocandins, amphotericin, Biological Sciences, Medical and Health Sciences, Microbiology, Clinical sciences
Abstract

It is important to realize that guidelines cannot always account for individual variation among patients. They are not intended to supplant physician judgment with respect to particular patients or special clinical situations. IDSA considers adherence to these guidelines to be voluntary, with the ultimate determination regarding their application to be made by the physician in the light of each patient's individual circumstances.

Published
2016

34. A Randomized, Placebo-Controlled, Phase II Trial of Intravenous Allogeneic Non-HLA Matched, Unrelated Donor, Cord Blood Infusion for Ischemic Stroke

Author

Laskowitz, Daniel T, primary, Troy, Jesse, additional, Poehlein, Emily, additional, Bennett, Ellen R, additional, Shpall, Elizabeth J, additional, Wingard, John R, additional, Freed, Brian, additional, Belagaje, Samir R, additional, Khanna, Anna, additional, Jones, William, additional, Volpi, John J, additional, Marrotte, Eric, additional, and Kurtzberg, Joanne, additional

Published
2023
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35. Patient-Reported Outcomes in Long-Term Survivors of Autologous Hematopoietic Cell Transplantation in Multiple Myeloma

Author

Chakraborty, Rajshekhar, Yi, Jean, Rybicki, Lisa, Preussler, Jaime, Deol, Abhinav, Loren, Alison, Savani, Bipin, Jim, Heather S.L., Cerny, Jan, Reynolds, Jana, Whitten, Jennifer, Wingard, John R., McGuirk, Joseph P., Uberti, Joseph, Khera, Nandita, Stiff, Patrick, Jaglowski, Samantha M., Hashmi, Shahrukh, Holtan, Shernan G., Devine, Steven, Hahn, Theresa, Whalen, Victoria L., Saber, Wael, Wood, William, Baker, K. Scott, Syrjala, Karen, and Majhail, Navneet S.

Published
2023
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36. Health-Related Quality of Life Outcomes in Older Hematopoietic Cell Transplantation Survivors

Author

Hong, Sanghee, Zhao, Jing, Wang, Shu, Wang, Han, Lee, Ji-Hyun, Farhadfar, Nosha, McGuirk, Joseph P., Savani, Bipin N., Shahrukh, Hashmi K., Stiff, Patrick, Khera, Nandita, Hahn, Theresa, Loren, Alison W., Jaglowski, Samantha M., Wood, William A., Saber, Wael, Cerny, Jan, Holtan, Shernan G., Reynolds, Jana M., Deol, Abhinav, Jim, Heather, Uberti, Joseph, Whalen, Victoria, Yi, Jean C., Preussler, Jaime, Baker, K. Scott, Shaw, Bronwen E., Devine, Steven, Syrjala, Karen, Majhail, Navneet S., Wingard, John R., and Al-Mansour, Zeina

Published
2023
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37. Impact of autologous blood transfusion after bone marrow harvest on unrelated donor’s health and outcome: a CIBMTR analysis

Author

Farhadfar, Nosha, Murthy, Hemant S., Logan, Brent R., Sees, Jennifer A., Ayas, Mouhab, Battiwalla, Minoo, Beitinjaneh, Amer M., Chhabra, Saurabh, Diaz, Miguel Angel, Engles, Katie, Frangoul, Haydar, Ganguly, Siddhartha, Gergis, Usama, Kamani, Nayesh R., Kamble, Rammurti T., Kasow, Kimberly A., Lazarus, Hillard M., Liesveld, Jane L., Norkin, Maxim, O’ Donnell, Paul V., Olsson, Richard F., Rossmann, Susan, Savani, Bipin N., Schears, Raquel, Seo, Sachiko, Solh, Melhem M., Spitzer, Thomas, Sugrue, Michele, Yared, Jean A., Linenberger, Michael, Schwartz, Joseph, Pulsipher, Michael A., Shah, Nirali N., Switzer, Galen E., Confer, Dennis L., Shaw, Bronwen E., and Wingard, John R.

Published
2020
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39. Myeloablative vs reduced intensity T-cell–replete haploidentical transplantation for hematologic malignancy

Author

Solomon, Scott R., St. Martin, Andrew, Shah, Nirav N., Fatobene, Giancarlo, Al Malki, Monzr M., Ballen, Karen K., Bashey, Asad, Bejanyan, Nelli, Bolaños Meade, Javier, Brunstein, Claudio G., DeFilipp, Zachariah, Champlin, Richard E., Fuchs, Ephraim J., Hamadani, Mehdi, Hematti, Peiman, Kanakry, Christopher G., McGuirk, Joseph P., McNiece, Ian K., Ciurea, Stefan O., Pasquini, Marcelo C., Rocha, Vanderson, Romee, Rizwan, Patel, Sagar S., Vasu, Sumithira, Waller, Edmund K., Wingard, John R., Zhang, Mei-Jie, and Eapen, Mary

Published
2019
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40. Gilteritinib as Post-Transplant Maintenance for AML With Internal Tandem Duplication Mutation of FLT3.

Author

Levis, Mark J., Hamadani, Mehdi, Logan, Brent, Jones, Richard J., Singh, Anurag K., Litzow, Mark, Wingard, John R., Papadopoulos, Esperanza B., Perl, Alexander E., Soiffer, Robert J., Ustun, Celalettin, Ueda Oshima, Masumi, Uy, Geoffrey L., Waller, Edmund K., Vasu, Sumithra, Solh, Melhem, Mishra, Asmita, Muffly, Lori, Kim, Hee-Je, and Mikesch, Jan-Henrik

Published
2024
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41. Post-transplantation cyclophosphamide is associated with increased bacterial infections

Author

Ustun, Celalettin, primary, Chen, Min, additional, Kim, Soyoung, additional, Auletta, Jeffery J., additional, Batista, Marjorie V., additional, Battiwalla, Minoo, additional, Cerny, Jan, additional, Gowda, Lohith, additional, Hill, Joshua A., additional, Liu, Hongtao, additional, Munshi, Pashna N., additional, Nathan, Sunita, additional, Seftel, Matthew D., additional, Wingard, John R., additional, Chemaly, Roy F., additional, Dandoy, Christopher E., additional, Perales, Miguel-Angel, additional, Riches, Marcie, additional, and Papanicolaou, Genovefa A., additional

Published
2023
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42. Incidence and impact of fungal infections in post-transplant Cyclophosphamide (PTCy)-based graft-versus-host disease prophylaxis and haploidentical hematopoietic cell transplantation: A CIBMTR analysis

Author

Papanicolaou, Genovefa A., primary, Chen, Min, additional, He, Naya, additional, Martens, Michael J., additional, Kim, Soyoung, additional, Batista, Marjorie V., additional, Bhatt, Neel S., additional, Hematti, Peiman, additional, Hill, Joshua A., additional, Liu, Hongtao, additional, Nathan, Sunita, additional, Seftel, Matthew D., additional, Sharma, Akshay, additional, Waller, Edmund K., additional, Wingard, John R., additional, Young, Jo-Anne H., additional, Dandoy, Christopher E., additional, Perales, Miguel-Angel, additional, Chemaly, Roy F., additional, Riches, Marcie, additional, and Ustun, Celalettin, additional

Published
2023
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43. Health-Related Quality of Life in Young Adult Survivors of Hematopoietic Cell Transplantation

Author

Rotz, Seth J., Yi, Jean C., Hamilton, Betty K., Wei, Wei, Preussler, Jaime M., Cerny, Jan, Deol, Abhinav, Jim, Heather, Khera, Nandita, Hahn, Theresa, Hashmi, Shahrukh K., Holtan, Shernan, Jaglowski, Samantha M., Loren, Alison W., McGuirk, Joseph, Reynolds, Jana, Saber, Wael, Savani, Bipin N., Stiff, Patrick, Uberti, Joseph, Wingard, John R., Wood, William A., Baker, K. Scott, Majhail, Navneet S., and Syrjala, Karen L.

Published
2022
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44. The Impact of Pre-Apheresis Health Related Quality of Life on Peripheral Blood Progenitor Cell Yield and Donor's Health and Outcome: Secondary Analysis of Patient-Reported Outcome Data from the RDSafe and BMT CTN 0201 Clinical Trials

Author

Farhadfar, Nosha, Ahn, Kwang Woo, Bo-Subait, Stephanie, Logan, Brent, Stefanski, Heather E., Hsu, Jack W., Panch, Sandhya, Confer, Dennis, Liu, Hien, Badawy, Sherif M., Beitinjaneh, Amer, Diaz, Miguel A., Hildebrandt, Gerhard C., Kelkar, Amar H., Lazarus, Hillard M., Murthy, Hemant S., Preussler, Jaime M., Schears, Raquel M., Sharma, Akshay, van der Poel, Marjolein, Bruce, Jessica G., Pulsipher, Michael A., Shaw, Bronwen E., Wingard, John R., and Switzer, Galen E.

Published
2022
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46. Beyond maximum grade: modernising the assessment and reporting of adverse events in haematological malignancies

Author

Thanarajasingam, Gita, Minasian, Lori M, Baron, Frederic, Cavalli, Franco, De Claro, R Angelo, Dueck, Amylou C, El-Galaly, Tarec C, Everest, Neil, Geissler, Jan, Gisselbrecht, Christian, Gribben, John, Horowitz, Mary, Ivy, S Percy, Jacobson, Caron A, Keating, Armand, Kluetz, Paul G, Krauss, Aviva, Kwong, Yok Lam, Little, Richard F, Mahon, Francois-Xavier, Matasar, Matthew J, Mateos, María-Victoria, McCullough, Kristen, Miller, Robert S, Mohty, Mohamad, Moreau, Philippe, Morton, Lindsay M, Nagai, Sumimasa, Rule, Simon, Sloan, Jeff, Sonneveld, Pieter, Thompson, Carrie A, Tzogani, Kyriaki, van Leeuwen, Flora E, Velikova, Galina, Villa, Diego, Wingard, John R, Wintrich, Sophie, Seymour, John F, and Habermann, Thomas M

Published
2018
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47. ASBMT Practice Guidelines Committee Survey on Long-Term Follow-Up Clinics for Hematopoietic Cell Transplant Survivors

Author

Hashmi, Shahrukh K., Lee, Stephanie J., Savani, Bipin N., Burns, Linda, Wingard, John R., Perales, Miguel-Angel, Palmer, Jeanne, Chow, Eric, Meyer, Everett, Marks, David, Mohty, Mohamad, Inamoto, Yoshihiro, Rodriguez, Cesar, Nagler, Arnon, Sauter, Craig, Komanduri, Krishna V., Pidala, Joseph, Hamadani, Mehdi, Johnston, Laura, Shah, Nina, Shaughnessy, Paul, Hamilton, Betty K., Majhail, Navneet, Kharfan-Dabaja, Mohamed A., Schriber, Jeff, DeFilipp, Zachariah, Tarlock, Katherine G., Fanning, Suzanne, Curtin, Peter, Rizzo, J. Douglas, and Carpenter, Paul A.

Published
2018
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48. Serological Profiling of a Candida albicans Protein Microarray Reveals Permanent Host-Pathogen Interplay and Stage-Specific Responses during Candidemia

Author

Mochon, A. Brian, Ye, Jin, Kayala, Matthew A., Wingard, John R., Clancy, Cornelius J., Nguyen, M. Hong, Felgner, Philip, Baldi, Pierre, and Liu, Haoping

Subjects
foam cell-formation, intracellular bacterial-infection, chlamydia-trachomatis infection, receptor-interacting protein-2, toll-like receptors, nf-kappa-b, ifn-gamma, nitric-oxide, immune-responses, in-vivo
Abstract

Candida albicans in the immunocompetent host is a benign member of the human microbiota. Though, when host physiology is disrupted, this commensal-host interaction can degenerate and lead to an opportunistic infection. Relatively little is known regarding the dynamics of C. albicans colonization and pathogenesis. We developed a C. albicans cell surface protein microarray to profile the immunoglobulin G response during commensal colonization and candidemia. The antibody response from the sera of patients with candidemia and our negative control groups indicate that the immunocompetent host exists in permanent host-pathogen interplay with commensal C. albicans. This report also identifies cell surface antigens that are specific to different phases (i.e. acute, early and mid convalescence) of candidemia. We identified a set of thirteen cell surface antigens capable of distinguishing acute candidemia from healthy individuals and uninfected hospital patients with commensal colonization. Interestingly, a large proportion of these cell surface antigens are involved in either oxidative stress or drug resistance. In addition, we identified 33 antigenic proteins that are enriched in convalescent sera of the candidemia patients. Intriguingly, we found within this subset an increase in antigens associated with heme-associated iron acquisition. These findings have important implications for the mechanisms of C. albicans colonization as well as the development of systemic infection.Author SummaryCandida albicans has both a benign and pathogenic association with the human host. Previous to this study, little was known in regard to how the host humoral system responds to the commensal colonization of C. albicans, as well as the development of hematogenously disseminated candidiasis. We show using a C. albicans cell surface protein microarray that the immunocompetent host exists in permanent host-pathogen interplay with commensal C. albicans, and undergoes stage-specific antibody responses as the yeast transitions from a benign microbe to an opportunistic fungal pathogen. Also identified were serological signatures specific for acute and convalescent stages of candidemia. Our findings provide new insight in the characterization of potential serodiagnostic antigens and vaccine candidates to the opportunistic pathogen C. albicans.

Published
2010

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