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1. Dual T cell depletion for graft versus host disease prevention in peripheral blood haploidentical hematopoietic cell transplantation for adults with hematological malignancies

Author

Alfaro Moya, Tommy, Salas, Maria Queralt, Santos Carreira, Abel, Atenafu, Eshetu G., Law, Arjun Datt, Lam, Wilson, Pasic, Ivan, Kim, Dennis (Dong Hwan), Michelis, Fotios V., Novitzky Basso, Igor, Gerbitz, Armin, Lipton, Jeffrey Howard, Kumar, Rajat, Mattsson, Jonas, and Viswabandya, Auro

Published
2024
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7. Phase 2 Study of Anti-Human Cytomegalovirus Monoclonal Antibodies for Prophylaxis in Hematopoietic Cell Transplantation

Author

Maertens, Johan, Logan, Aaron C, Jang, Junho, Long, Gwynn, Tang, Jih-Luh, Hwang, William YK, Koh, Liang Piu, Chemaly, Roy, Gerbitz, Armin, Winkler, Julia, Yeh, Su-Peng, Hiemenz, John, Christoph, Sandra, Lee, Dong-Gun, Wang, Po-Nan, Holler, Ernst, Mielke, Stephan, Akard, Luke, Yeo, Adeline, Ramachandra, Sangana, Smith, Kristin, Pertel, Peter, and Segal, Florencia

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Infectious Diseases, Transplantation, Cancer, Clinical Trials and Supportive Activities, Prevention, Patient Safety, Biotechnology, Immunization, Clinical Research, Stem Cell Research - Nonembryonic - Human, Stem Cell Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Infection, Administration, Intravenous, Adult, Aged, Antibodies, Viral, Antiviral Agents, Cytomegalovirus Infections, Female, Graft vs Host Disease, Hematopoietic Stem Cell Transplantation, Humans, Male, Middle Aged, Placebos, Treatment Outcome, Viral Load, Young Adult, hematopoietic stem cell transplantation, human cytomegalovirus, prophylaxis, Microbiology, Medical Microbiology, Pharmacology and Pharmaceutical Sciences, Medical microbiology, Pharmacology and pharmaceutical sciences
Abstract

Human cytomegalovirus (HCMV) can cause significant disease in immunocompromised patients, and treatment options are limited by toxicities. CSJ148 is a combination of two anti-HCMV human monoclonal antibodies (LJP538 and LJP539) that bind to and inhibit the functions of viral HCMV glycoprotein B (gB) and the pentameric complex, consisting of glycoproteins gH, gL, UL128, UL130, and UL131. In this phase 2, randomized, placebo-controlled trial, we evaluated the safety and efficacy of CSJ148 for prophylaxis of HCMV in patients undergoing allogeneic hematopoietic stem cell transplantation. As would be expected in the study population, all the patients (100%) reported at least one treatment-emergent adverse event. There were 22 deaths during this study, and over 80% of the patients receiving placebo or CSJ148 developed at least one adverse event of grade 3 or higher severity. No subject who received antibody developed a hypersensitivity- or infusion-related reaction. CSJ148-treated patients showed trends toward decreased viral load, shorter median duration of preemptive therapy, and fewer courses of preemptive therapy. However, the estimated probability that CSJ148 decreases the need for preemptive therapy compared to placebo was 69%, with a risk ratio of 0.89 and a 90% credible interval of 0.61 to 1.31. The primary efficacy endpoint was therefore not met, indicating that CSJ148 did not prevent clinically significant HCMV reactivation in recipients of allogeneic hematopoietic cell transplants. (This study has been registered at ClinicalTrials.gov under identifier NCT02268526 and at EudraCT under number 2017-002047-15.).

Published
2020

9. Allogeneic hematopoietic stem cell transplantation for adult HLH: a retrospective study by the chronic malignancies and inborn errors working parties of EBMT

Author

Machowicz, Rafal, Suarez, Felipe, Wiktor-Jedrzejczak, Wieslaw, Eikema, Diderik-Jan, de Wreede, Liesbeth C., Blok, Henric-Jan, Isaksson, Cecilia, Einsele, Hermann, Poiré, Xavier, van Dorp, Suzanne, Nikolousis, Emmanouil, Johansson, Jan-Erik, Kobbe, Guido, Zecca, Marco, Arnold, Renate, Gerbitz, Armin, Finke, Jürgen, Díez-Martín, Jose Luis, Bonifazi, Francesca, McQuaker, Grant, Lenhoff, Stig, Rohrlich, Pierre-Simon, Theobald, Matthias, Ljungman, Per, Collin, Matthew, Albert, Michael H., Ehninger, Gerhard, Carlson, Kristina, Halaburda, Kazimierz, Lehmberg, Kai, Schönland, Stefan, Yakoub-Agha, Ibrahim, Gennery, Andrew R., Lankester, Arjan C., and Kröger, Nicolaus

Published
2022
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11. Letermovir as secondary prophylaxis of cytomegalovirus infection after allogeneic hematopoietic cell transplantation: A single center experience.

Author

Desai, Nihar, Pasic, Ivan, Law, Arjun D., Lam, Wilson, Gerbitz, Armin, Viswabandya, Auro, Kim, Dennis D., Kumar, Rajat, Mattsson, Jonas, Novitzky‐Basso, Igor, and Michelis, Fotios V.

Subjects
HEMATOPOIETIC stem cell transplantation, CYTOMEGALOVIRUS diseases, PREVENTIVE medicine, CYCLOPHOSPHAMIDE, GLOBULINS
Abstract

Letermovir, a novel anti‐cytomegalovirus (CMV) agent acts by inhibiting the viral terminase complex and is approved for primary prophylaxis in CMV seropositive patients post allogeneic hematopoietic cell transplantation (HCT). The favorable efficacy and safety profile make it an attractive option for use as secondary prophylaxis in patients at high‐risk for CMV reactivation. In this study, we report the efficacy and safety of letermovir secondary prophylaxis after at least one treated episode of CMV reactivation in a cohort of 39 high‐risk patients. Thirty two (82%) patients received anti‐thymocyte globulin (ATG), 27 (69%) received a combination of ATG and post‐transplant cyclophosphamide for graft‐versus‐host disease (GVHD) prophylaxis. Twenty one patients (54%) received CMV seronegative grafts. In addition, 18 (46%) patients had HLA mismatched unrelated or haploidentical donors while 18 (46%) had active GVHD requiring immunosuppression at the time of commencing secondary prophylaxis. Letermovir was initiated at a median of 47 days (range, 41–56) after HCT and was administered for a median duration of 77 days (range, 46–90). A single breakthrough CMV reactivation was noted in this high‐risk cohort. Four additional episodes of CMV reactivation occurred at a median of 28 days (range, 23–59 days) after discontinuation of secondary prophylaxis. The drug was well tolerated and 77% of the cohort completed the planned duration of secondary prophylaxis. None of the patients discontinued treatment due to treatment‐related adverse effects. In conclusion, letermovir is effective and well tolerated and may be considered for secondary prophylaxis in patients at high risk for CMV reactivation. Prospective studies are required to validate these findings. [ABSTRACT FROM AUTHOR]

Published
2024
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12. Impact of cytomegalovirus (CMV) seroconversion pre‐allogeneic hematopoietic cell transplantation on posttransplant outcomes.

Author

Sayyed, Ayman, Wilson, Leeann, Stavi, Vered, Chen, Shiyi, Chen, Carol, Mattsson, Jonas, Lipton, Jeffrey H., Kim, Dennis D., Viswabandya, Auro, Kumar, Rajat, Lam, Wilson, Law, Arjun D., Gerbitz, Armin, Pasic, Ivan, Novitzky‐Basso, Igor, Mazzulli, Tony, and Michelis, Fotios V.

Subjects
HEMATOPOIETIC stem cell transplantation, STEM cell transplantation, IMMUNOGLOBULIN M, IMMUNOGLOBULIN G, SEROCONVERSION, HIV seroconversion
Abstract

Cytomegalovirus (CMV) reactivation post‐allogeneic hematopoietic cell transplantation (post‐alloHCT) increases morbidity and mortality. We sought to determine the frequency of CMV seroconversion in patients pre‐alloHCT and to investigate the impact on posttransplant outcomes. We retrospectively investigated 752 adult patients who underwent alloHCT at our center from January 2015 to February 2020 before the adoption of letermovir prophylaxis. CMV serology was assessed at consult and pretransplant. The cohort was divided into four groups based on pretransplant CMV seroconversion: negative to positive (Group 1), positive to negative (Group 2), consistently negative (Group 3), and consistently positive (Group 4). Eighty‐nine patients (12%) had seroconverted from negative to positive, 17 (2%) from positive to negative, 151 (20%) were consistently seronegative, and 495 (66%) were consistently seropositive pretransplant. For the four CMV serostatus groups, cumulative incidence of CMV reactivation at 6 months posttransplant was 4.5%, 47.1%, 6.6%, and 76.6% for Groups 1, 2, 3, and 4, respectively (p <.0001). No differences between groups were seen regarding Grade III–IV acute graft‐versus‐host disease (GVHD) (p =.91), moderate/severe chronic GVHD (p =.41), or graft failure (p =.28). On multivariable analysis, there was no impact of CMV serostatus group on overall survival (p =.67), cumulative incidence of relapse (p =.83) or non‐relapse mortality. alloHCT patients who demonstrate CMV seroconversion pretransplant from negative to positive have a very low risk of CMV reactivation posttransplant. The observed seroconversion may be due to passive CMV immunity acquired through blood products. Quantitative CMV immunoglobulin G/immunoglobulin M pretransplant may help differentiate between true seroconversion and passively transmitted CMV immunoglobulin. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Outcomes of Antithymocyte Globulin-Post-Transplantation Cyclophosphamide-Cyclosporine-Based versus Antithymocyte Globulin-Based Prophylaxis for 10/10 HLA-Matched Unrelated Donor Allogeneic Hematopoietic Cell Transplantation

Author

Salas, Maria Queralt, Alfaro-Moya, Tommy, Atenafu, Eshetu G., Datt Law, Arjun, Lam, Wilson, Pasic, Ivan, Novitzky-Basso, Igor, Santos Carreira, Abel, Chen, Carol, Michelis, Fotios V., Gerbitz, Armin, Howard Lipton, Jeffrey, Kim, Dennis (Dong Hwan), Kumar, Rajat, Mattsson, Jonas, and Viswabandya, Auro

Published
2024
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17. Propensity Score Matching Analysis Comparing the Efficacy and Steroid Tapering Benefit of Extracorporeal Photopheresis to Best Available Therapy in Third-Line or Beyond Treatment for Chronic GvHD

Author

Novitzky-Basso, Igor, Patriquin, Christopher, Linn, Swe Mar, Chiarello, Caden, Pasic, Ivan, Lam, Wilson, Law, Arjun, Michelis, Fotios V., Gerbitz, Armin, Viswabandya, Auro, Lipton, Jeffrey, Kumar, Rajat, Mattsson, Jonas, Barth, David, and Kim, Dennis Dong Hwan

Published
2023
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18. Prognostic impact of the adverse molecular-genetic profile on long-term outcomes following allogeneic hematopoietic stem cell transplantation in acute myeloid leukemia

Author

Daher-Reyes, Georgina, Kim, TaeHyung, Novitzky-Basso, Igor, Kim, Kyuoung Ha, Smith, Adam, Stockley, Tracy, Capochichi, Jose-Mario, Al-Shaibani, Zeyad, Pasic, Ivan, Law, Arjun, Lam, Wilson, Michelis, Fotios V., Gerbitz, Armin, Viswabandya, Auro, Lipton, Jeffrey, Kumar, Rajat, Mattsson, Jonas, Schimmer, Aaron, McNamara, Caroline, Murphy, Tracy, Maze, Dawn, Gupta, Vikas, Sibai, Hassan, Chan, Steven, Yee, Karen, Minden, Mark, Zhang, Zhaolei, Schuh, Andre, and Kim, Dennis D. H.

Published
2021
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20. Letermovir prophylaxis for cytomegalovirus reactivation in allogeneic hematopoietic cell transplant recipients : Single center Canadian data

Author

Pang, Ian, Chen, Peggy, Trinh, Gertrude V., Remberger, Mats, Novitzky-Basso, Igor, Gerbitz, Armin, Kim, Dennis D., Kumar, Rajat, Lam, Wilson, Law, Arjun D., Lipton, Jeffrey H., Viswabandya, Auro, Pasic, Ivan, Mattsson, Jonas, Michelis, Fotios V., Pang, Ian, Chen, Peggy, Trinh, Gertrude V., Remberger, Mats, Novitzky-Basso, Igor, Gerbitz, Armin, Kim, Dennis D., Kumar, Rajat, Lam, Wilson, Law, Arjun D., Lipton, Jeffrey H., Viswabandya, Auro, Pasic, Ivan, Mattsson, Jonas, and Michelis, Fotios V.

Abstract

Background: Cytomegalovirus (CMV) is associated with morbidity and mortality following allogeneic hematopoietic cell transplantation (alloHCT). Letermovir is a novel antiviral agent that prevents CMV reactivation in alloHCT patients, with limited data regarding influence on post-alloHCT outcomes. Methods: We retrospectively examined 273 alloHCT recipients, 158 in the non-letermovir cohort (NLC), and 115 in the cohort using letermovir prophylaxis (LC). Patients that received letermovir were CMV-seropositive and met criteria for high risk of CMV reactivation. Results: Median start of letermovir was 21 days post-alloHCT, median duration of prophylaxis was 86 days. Letermovir prophylaxis demonstrated a statistically significant reduction in first CMV reactivation (at 200 days post 63.9% in the NLC vs. 35.7% in the LC; p < .001). On univariate analysis at 1 year, overall survival (OS) for NLC was 79.6% and 79.5% for LC (p = .54). Non relapse mortality (NRM) at 1 year for NLC was 12% and 12.3% for LC (p = .69). Cumulative incidence of relapse (CIR) at 1 year was 13.9% for NLC versus 17.1 for the LC (p = .27). On multivariable analysis, there was no significant difference between the two cohorts for OS, NRM, and CIR. Conclusions: Letermovir prophylaxis started at day +21 post-alloHCT reduced CMV reactivation, with no impact on posttransplant outcomes.

Published
2024
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21. Choosing Between Older Matched Sibling Donor and Younger Matched Unrelated Donor in Allogeneic Hematopoietic Cell Transplantation: Comparison of Clinical Outcomes in Acute Myeloid Leukemia and Myelodysplastic Syndrome

Author

Pereira, Mariana Pinto, Remberger, Mats, Chen, Carol, Gerbitz, Armin, Kim, Dennis Dong Hwan, Kumar, Rajat, Lam, Wilson, Law, Arjun Datt, Lipton, Jeffrey H., Michelis, Fotios V., Novitzky-Basso, Igor, Viswabandya, Auro, Mattsson, Jonas, and Pasic, Ivan

Published
2023
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22. Interaction Between High-Dose Intravenous Busulfan and Post-Transplantation Cyclophosphamide on Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplantation

Author

Santos Carreira, Abel, Salas, Maria Queralt, Remberger, Mats, Novitzky-Basso, Igor, Law, Arjun Datt, Lam, Wilson, Pasic, Ivan, Mazzulli, Tony, Cserti-Gazdewich, Christine, Kim, Dennis (Dong Hwan), Michelis, Fotios V., Viswabandya, Auro, Gerbitz, Armin, Lipton, Jeffrey Howard, Kumar, Rajat, Hassan, Moustapha, and Mattsson, Jonas

Published
2023
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25. Life Is a Highway or a Long and Winding Road: A Look into Why Some Transplants Lead to Longer Length of Stay (LOS)

Author

Sayyed, Ayman, primary, Remberger, Mats, additional, Clarke, Susan, additional, Chen, Carol, additional, Lipton, Jeffrey H, additional, Kim, Dennis (Dong Hwan), additional, Viswabandya, Auro, additional, Kumar, Rajat, additional, Lam, Wilson, additional, Law, Arjun D., additional, Gerbitz, Armin, additional, Pasic, Ivan, additional, Novitzky-Basso, Igor, additional, Michelis, Fotios V., additional, and Mattsson, Jonas, additional

Published
2024
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26. Impact of Letermovir on Outcomes in Cytomegalovirus Seropositive Patients Undergoing Allogeneic HCT: Exploring Outcomes across Ethnicities

Author

Singhabahu, Sanjay, primary, Herrity, Elizabeth, additional, Remberger, Mats, additional, Pang, Ian, additional, Novitzky-Basso, Igor, additional, Pasic, Ivan, additional, Lam, Wilson, additional, Law, Arjun D., additional, Viswabandya, Auro, additional, Gerbitz, Armin, additional, Kumar, Rajat, additional, Kim, Dennis Dong Hwan, additional, Lipton, Jeffrey H, additional, Mattsson, Jonas, additional, and Michelis, Fotios V., additional

Published
2024
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27. Eltrombopag in the Treatment of Post Allogeneic Hematopoietic Stem Cell Transplantation Cytopenia: Efficacy, Response Durability and Potential Cost Benefit of Early Drug Tapering.

Author

Al-Omari, Rawan, primary, Nampoothiri, Ram Vasudevan, additional, Atenafu, Eshetu G., additional, SakhdarI, Ali, additional, Lipton, Jeff, additional, Kim, Dennis Dong Hwan, additional, Lam, Wilson, additional, Law, Arjun D., additional, Gerbitz, Armin, additional, Pasic, Ivan, additional, Novitzky-Basso, Igor, additional, Viswabandya, Auro, additional, Michelis, Fotios V., additional, Mattsson, Jonas, additional, and Kumar, Rajat, additional

Published
2024
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28. Exploring Outcomes By Ethnicity in Allogeneic Hematopoietic Cell Transplantation

Author

Herrity, Elizabeth, primary, Singhabahu, Sanjay, additional, Remberger, Mats, additional, Novitzky-Basso, Igor, additional, Pasic, Ivan, additional, Lam, Wilson, additional, Law, Arjun D., additional, Viswabandya, Auro, additional, Gerbitz, Armin, additional, Kumar, Rajat, additional, Kim, Dennis Dong Hwan, additional, Lipton, Jeffrey H, additional, Mattsson, Jonas, additional, and Michelis, Fotios V., additional

Published
2024
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29. A Single Center Experience of Central Nervous System Manifestations of Graft Versus Host Disease.

Author

Khaire, Niranjan S, primary, Cyriac, Sunu, additional, Nampoothiri, Ram Vasudevan, additional, Gerbitz, Armin, additional, Kim, Dennis (Dong Hwan), additional, Kumar, Rajat, additional, Lam, Wilson, additional, Law, Arjun D., additional, Lipton, Jeffrey H, additional, Pasic, Ivan, additional, Michelis, Fotios V., additional, Novitzky-Basso, Igor, additional, Mattsson, Jonas, additional, and Viswabandya, Auro, additional

Published
2024
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30. Limited Impact of Donor-Recipient Weight Difference on Outcomes of Allogeneic Hematopoietic Cell Transplantation

Author

Chiarello, Caden, primary, Remberger, Mats, additional, Chen, Carol, additional, Gerbitz, Armin, additional, Kim, Dennis (Dong Hwan), additional, Kumar, Rajat, additional, Lam, Wilson, additional, Law, Arjun D., additional, Lipton, Jeff, additional, Michelis, Fotios V., additional, Novitzky-Basso, Igor, additional, Viswabandya, Auro, additional, Mattsson, Jonas, additional, and Pasic, Ivan, additional

Published
2024
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32. Outcome of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Age >69 Years with Acute Myelogenous Leukemia: On Behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation

Author

Ringdén, Olle, Boumendil, Ariane, Labopin, Myriam, Canaani, Jonathan, Beelen, Dietrich, Ehninger, Gerhard, Niederwieser, Dietger, Finke, Jurgen, Stelljes, Matthias, Gerbitz, Armin, Ganser, Arnold, Kröger, Nicolaus, Kantz, Lothar, Brecht, Arne, Savani, Bipin, Sadeghi, Behnam, Mohty, Mohamad, and Nagler, Arnon

Published
2019
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33. Changes in Immunosuppressive Treatment of Chronic Graft-versus-Host Disease: Comparison of 2 Surveys within Allogeneic Hematopoietic Stem Cell Transplant Centers in Germany, Austria, and Switzerland

Author

Wolff, Daniel, Hilgendorf, Inken, Wagner-Drouet, Eva, Jedlickova, Zuzana, Ayuk, Francis, Zeiser, Robert, Schäfer-Eckart, Kerstin, Gerbitz, Armin, Stadler, Michael, Klein, Stefan, Middeke, Jan-Moritz, Lawitschka, Anita, Winkler, Julia, Halter, Jörg, Holler, Ernst, Kobbe, Guido, Stelljes, Matthias, Ditschkowski, Markus, and Greinix, Hildegard

Published
2019
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34. Prevention of CMV/EBV reactivation by double-specific T cells in patients after allogeneic stem cell transplantation: results from the randomized phase I/IIa MULTIVIR-01 study

Author

Gerbitz, Armin, primary, Gary, Regina, additional, Aigner, Michael, additional, Moosmann, Andreas, additional, Kremer, Anita, additional, Schmid, Christoph, additional, Hirschbuehl, Klaus, additional, Wagner, Eva, additional, Hauptrock, Beate, additional, Teschner, Daniel, additional, Roesler, Wolf, additional, Spriewald, Bernd, additional, Tischer, Johanna, additional, Moi, Stephanie, additional, Balzer, Heidi, additional, Schaffer, Stefanie, additional, Bausenwein, Judith, additional, Wagner, Anja, additional, Schmidt, Franziska, additional, Brestrich, Jens, additional, Ullrich, Barbara, additional, Maas, Stefanie, additional, Herold, Susanne, additional, Strobel, Julian, additional, Zimmermann, Robert, additional, Weisbach, Volker, additional, Hansmann, Leo, additional, Lammoglia-Cobo, Fernanda, additional, Remberger, Mats, additional, Stelljes, Matthias, additional, Ayuk, Francis, additional, Zeiser, Robert, additional, and Mackensen, Andreas, additional

Published
2023
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35. Letermovir prophylaxis for cytomegalovirus reactivation in allogeneic hematopoietic cell transplant recipients: Single center Canadian data

Author

Pang, Ian, primary, Chen, Peggy, additional, Trinh, Gertrude V., additional, Remberger, Mats, additional, Novitzky‐Basso, Igor, additional, Gerbitz, Armin, additional, Kim, Dennis D., additional, Kumar, Rajat, additional, Lam, Wilson, additional, Law, Arjun D., additional, Lipton, Jeffrey H., additional, Viswabandya, Auro, additional, Pasic, Ivan, additional, Mattsson, Jonas, additional, and Michelis, Fotios V., additional

Published
2023
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36. CT-343 Outcomes of Allogeneic Hematopoietic Cell Transplantation (HCT) for Lymphoma Patients: Single-Institution Experience

Author

Altareb, Majed, primary, Sayyed, Ayman, additional, Gerbitz, Armin, additional, Kim, Dennis, additional, Kumar, Rajat, additional, Lam, Wilson, additional, Law, Arjun, additional, Lipton, Jeffrey, additional, Michelis, Fotios, additional, Novitzky-Basso, Igor, additional, Viswabandya, Auro, additional, Mattsson, Jonas, additional, and Pasic, Ivan, additional

Published
2023
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37. POSTER: CT-343 Outcomes of Allogeneic Hematopoietic Cell Transplantation (HCT) for Lymphoma Patients: Single-Institution Experience

Author

Altareb, Majed, primary, Sayyed, Ayman, additional, Gerbitz, Armin, additional, Kim, Dennis, additional, Kumar, Rajat, additional, Lam, Wilson, additional, Law, Arjun, additional, Lipton, Jeffrey, additional, Michelis, Fotios, additional, Novitzky-Basso, Igor, additional, Viswabandya, Auro, additional, Mattsson, Jonas, additional, and Pasic, Ivan, additional

Published
2023
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40. A single centre, real-world experience of chronic GVHD treatment using ibrutinib, Imatinib and ruxolitinib and its treatment outcomes

Author

Linn, Swe Mar, primary, Novitzky-Basso, Igor, additional, Abduljalil, Omar, additional, Pasic, Ivan, additional, Lam, Wilson, additional, Law, Arjun, additional, Michelis, Fotios V., additional, Gerbitz, Armin, additional, Viswabandya, Auro, additional, Lipton, Jeffrey, additional, Kumar, Rajat, additional, Mattsson, Jonas, additional, and Kim, Dennis Dong Hwan, additional

Published
2023
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41. Influence of conditioning regimen intensity on outcomes post‐allogeneic hematopoietic cell transplantation for acute myeloid leukemia in complete morphological remission

Author

Alfaro Moya, Tommy, primary, Mattsson, Jonas, additional, Remberger, Mats, additional, Lipton, Jeffrey H., additional, Kim, Dennis D., additional, Viswabandya, Auro, additional, Kumar, Rajat, additional, Lam, Wilson, additional, Law, Arjun D., additional, Gerbitz, Armin, additional, Pasic, Ivan, additional, Novitzky‐Basso, Igor, additional, and Michelis, Fotios V., additional

Published
2023
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43. Supplementary Figure from Immune Phenotypes and Target Antigens of Clonally Expanded Bone Marrow T Cells in Treatment-Naïve Multiple Myeloma

Author

Welters, Carlotta, primary, Lammoglia Cobo, María Fernanda, primary, Stein, Christian Alexander, primary, Hsu, Meng-Tung, primary, Ben Hamza, Amin, primary, Penter, Livius, primary, Chen, Xiaojing, primary, Buccitelli, Christopher, primary, Popp, Oliver, primary, Mertins, Philipp, primary, Dietze, Kerstin, primary, Bullinger, Lars, primary, Moosmann, Andreas, primary, Blanc, Eric, primary, Beule, Dieter, primary, Gerbitz, Armin, primary, Strobel, Julian, primary, Hackstein, Holger, primary, Rahn, Hans-Peter, primary, Dornmair, Klaus, primary, Blankenstein, Thomas, primary, and Hansmann, Leo, primary

Published
2023
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44. Data from Immune Phenotypes and Target Antigens of Clonally Expanded Bone Marrow T Cells in Treatment-Naïve Multiple Myeloma

Author

Welters, Carlotta, primary, Lammoglia Cobo, María Fernanda, primary, Stein, Christian Alexander, primary, Hsu, Meng-Tung, primary, Ben Hamza, Amin, primary, Penter, Livius, primary, Chen, Xiaojing, primary, Buccitelli, Christopher, primary, Popp, Oliver, primary, Mertins, Philipp, primary, Dietze, Kerstin, primary, Bullinger, Lars, primary, Moosmann, Andreas, primary, Blanc, Eric, primary, Beule, Dieter, primary, Gerbitz, Armin, primary, Strobel, Julian, primary, Hackstein, Holger, primary, Rahn, Hans-Peter, primary, Dornmair, Klaus, primary, Blankenstein, Thomas, primary, and Hansmann, Leo, primary

Published
2023
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45. Supplementary Data from Immune Phenotypes and Target Antigens of Clonally Expanded Bone Marrow T Cells in Treatment-Naïve Multiple Myeloma

Author

Welters, Carlotta, primary, Lammoglia Cobo, María Fernanda, primary, Stein, Christian Alexander, primary, Hsu, Meng-Tung, primary, Ben Hamza, Amin, primary, Penter, Livius, primary, Chen, Xiaojing, primary, Buccitelli, Christopher, primary, Popp, Oliver, primary, Mertins, Philipp, primary, Dietze, Kerstin, primary, Bullinger, Lars, primary, Moosmann, Andreas, primary, Blanc, Eric, primary, Beule, Dieter, primary, Gerbitz, Armin, primary, Strobel, Julian, primary, Hackstein, Holger, primary, Rahn, Hans-Peter, primary, Dornmair, Klaus, primary, Blankenstein, Thomas, primary, and Hansmann, Leo, primary

Published
2023
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46. Prevention of CMV/EBV reactivation by double-specific T cells in patients after allogeneic stem cell transplantation : results from the randomized phase I/IIa MULTIVIR-01 study

Author

Gerbitz, Armin, Gary, Regina, Aigner, Michael, Moosmann, Andreas, Kremer, Anita, Schmid, Christoph, Hirschbuehl, Klaus, Wagner, Eva, Hauptrock, Beate, Teschner, Daniel, Roesler, Wolf, Spriewald, Bernd, Tischer, Johanna, Moi, Stephanie, Balzer, Heidi, Schaffer, Stefanie, Bausenwein, Judith, Wagner, Anja, Schmidt, Franziska, Brestrich, Jens, Ullrich, Barbara, Maas, Stefanie, Herold, Susanne, Strobel, Julian, Zimmermann, Robert, Weisbach, Volker, Hansmann, Leo, Lammoglia-Cobo, Fernanda, Remberger, Mats, Stelljes, Matthias, Ayuk, Francis, Zeiser, Robert, Mackensen, Andreas, Gerbitz, Armin, Gary, Regina, Aigner, Michael, Moosmann, Andreas, Kremer, Anita, Schmid, Christoph, Hirschbuehl, Klaus, Wagner, Eva, Hauptrock, Beate, Teschner, Daniel, Roesler, Wolf, Spriewald, Bernd, Tischer, Johanna, Moi, Stephanie, Balzer, Heidi, Schaffer, Stefanie, Bausenwein, Judith, Wagner, Anja, Schmidt, Franziska, Brestrich, Jens, Ullrich, Barbara, Maas, Stefanie, Herold, Susanne, Strobel, Julian, Zimmermann, Robert, Weisbach, Volker, Hansmann, Leo, Lammoglia-Cobo, Fernanda, Remberger, Mats, Stelljes, Matthias, Ayuk, Francis, Zeiser, Robert, and Mackensen, Andreas

Abstract

IntroductionAllogeneic stem cell transplantation is used to cure hematologic malignancies or deficiencies of the hematopoietic system. It is associated with severe immunodeficiency of the host early after transplant and therefore early reactivation of latent herpesviruses such as CMV and EBV within the first 100 days are frequent. Small studies and case series indicated that application of herpes virus specific T cells can control and prevent disease in this patient population.MethodsWe report the results of a randomized controlled multi centre phase I/IIa study (MULTIVIR-01) using a newly developed T cell product with specificity for CMV and EBV derived from the allogeneic stem cell grafts used for transplantation. The study aimed at prevention and preemptive treatment of both viruses in patients after allogeneic stem cell transplantation targeting first infusion on day +30. Primary endpoints were acute transfusion reaction and acute-graft versus-host-disease after infusion of activated T cells.ResultsThirty-three patients were screened and 9 patients were treated with a total of 25 doses of the T cell product. We show that central manufacturing can be achieved successfully under study conditions and the product can be applied without major side effects. Overall survival, transplant related mortality, cumulative incidence of graft versus host disease and number of severe adverse events were not different between treatment and control groups. Expansion of CMV/EBV specific T cells was observed in a fraction of patients, but overall there was no difference in virus reactivation.DiscussionOur study results indicate peptide stimulated epitope specific T cells derived from stem cell grafts can be administered safely for prevention and preemptive treatment of reactivation without evidence for induction of acute graft versus host disease.Clinical trial registrationhttps://clinicaltrials.gov, identifier NCT02227641.

Published
2023
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47. Interaction Between High-Dose Intravenous Busulfan and Post-Transplantation Cyclophosphamide on Hemorrhagic Cystitis After Allogeneic Hematopoietic Cell Transplantation

Author

Carreira, Abel Santos, Salas, Maria Queralt, Remberger, Mats, Novitzky-Basso, Igor, Law, Arjun Datt, Lam, Wilson, Pasic, Ivan, Mazzulli, Tony, Cserti-Gazdewich, Christine, Kim, Dennis (Dong Hwan), Michelis, Fotios, V, Viswabandya, Auro, Gerbitz, Armin, Lipton, Jeffrey Howard, Kumar, Rajat, Hassan, Moustapha, Mattsson, Jonas, Carreira, Abel Santos, Salas, Maria Queralt, Remberger, Mats, Novitzky-Basso, Igor, Law, Arjun Datt, Lam, Wilson, Pasic, Ivan, Mazzulli, Tony, Cserti-Gazdewich, Christine, Kim, Dennis (Dong Hwan), Michelis, Fotios, V, Viswabandya, Auro, Gerbitz, Armin, Lipton, Jeffrey Howard, Kumar, Rajat, Hassan, Moustapha, and Mattsson, Jonas

Abstract

This study investigates the incidence and predictors of hemorrhagic cystitis (HC) in 960 adults undergoing allo- hematopoietic stem cell transplantation. Two hundred fifty-two (26.5%) patients received myeloablative conditioning regimens, and 81.4% received high-dose intravenous busulfan (HD Bu). Six hundred ninety-five (72.4%) patients received post-transplantation cyclophosphamide (PTCY)-based prophylaxis, and 91.4% additionally received anti-thymocyte globulin (ATG) and Cyclosporine A (CsA) (PTCY-ATG-CsA). Two hundred twenty-eight (23.8%) patients developed HC. The day 100 cumulative incidences of grades 2-4 and 3-4 HC were 11.1% and 4.9%. BK virus was isolated in 58.3% of urinary samples. Using HD BU myeloablative regimens increased the risk for grade 2-4 HC (hazard ratio [HR] = 1.97, P = .035), and HD BU combined with ATG-PTCY-CsA increased this 4 times (HR = 4.06, P < .001) for grade 2-4 HC compared to patients who received neither of these drugs. A significant correlation was documented between grade II-IV acute graft-versus-host disease and grade 2-4 HC (HR = 2.10, P < .001). Moreover, patients with BK-POS grade 2-4 HC had lower 1-year overall survival (HR = 1.51, P = .009) and higher non-relapse mortality (HR = 2.31, P < .001), and patients with BK-NEG grade 2-4 HC had comparable post-transplantation outcomes. In conclusion, intravenous HD Bu was identified as a predictor for grade 2-4 HC. Moreover, when HD Bu was combined with PTCY-ATG-CsA, the risk increased 4-fold. Based on the results provided by this study, preventing the onset of HC, especially in high-risk patients, is mandatory because its presence significantly increases the risk for mortality.

Published
2023
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48. Prognostic implication of pre-transplant FEV1 on long-term outcomes following allogeneic hematopoietic stem cell transplantation.

Author

Novitzky-Basso, Igor, Lam, Wilson, Chiarello, Caden, Pasic, Ivan, Law, Arjun D., Michelis, Fotios V., Gerbitz, Armin, Viswabandya, Auro, Lipton, Jeffrey H., Kumar, Rajat, Mattsson, Jonas, Messner, Hans A., Marras, Theodore K., Mittoo, Shikha, and Dong Hwan Kim, Dennis

Subjects
HEMATOPOIETIC stem cell transplantation, PROGNOSIS, HEMATOPOIETIC stem cells, STEM cell transplantation, PULMONARY function tests
Abstract

Background: Pre-transplant pulmonary function testing (PFT) is essential before allogeneic hematopoietic stem cell transplant (HCT), yet the optimal cutoff value for affecting transplant outcomes remains poorly defined. Study Design: Retrospective analysis of pre-HCT PFT data from 605 consecutive patients at the Princess Margaret Cancer Centre between January 1, 2004 and December 31, 2013 used binary recursive partitioning to identify cutoff values for overall survival (OS) as an endpoint of transplant outcomes. These values were compared to HCT comorbidity index (HCT-CI) FEV1 cutoffs for OS, cumulative incidence of relapse and non-relapse mortality. Results: FEV1 ≥ 81% was the identified cutoff point. The OS rate at 3 years showed 49.8% (FEV1 ≥ 81%) vs. 36.6% (<81%, p < .001). For HCT-CI cutoffs, the OS rate at 3 years for FEV1 ≥ 80%, 66%-80% and =65% were 49.0%, 38.1% and 37.6% (p = .011), respectively. Multivariate analysis confirmed that FEV1 ≥ 81% predicted reduced mortality (HR 0.682, p = .001). Subgroup analysis showed both FEV1 ≥ 81% and FEV1 by HCT-CI cutoffs may stratify patients according to OS and NRM risk in subgroups receiving myeloablative, but not reduced intensity conditioning. Conclusion: FEV1 ≥ 81% can predict OS and NRM in our cohort and is potentially simpler when risk stratifying patients undergoing allogeneic HCT, particularly those receiving myeloablative conditioning. [ABSTRACT FROM AUTHOR]

Published
2023
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49. HCT Frailty Scale for Younger and Older Adults Undergoing Allogeneic Hematopoietic Cell Transplantation

Author

Kumar, Rajat, primary, Salas, Maria, additional, Atenafu, Eshetu, additional, Pasic, Ivan, additional, Bascom, Ora, additional, Wilson, Leeann, additional, Lam, Wilson, additional, Law, Arjun, additional, Chen, Carol, additional, Novitzky-Basso, Igor, additional, Kim, Dennis, additional, Gerbitz, Armin, additional, Viswabandya, Auro, additional, Michelis, Fotios, additional, Lipton, Jeffrey, additional, Mattsson, Jonas, additional, and Alibhai, Shabbir, additional

Published
2023
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50. Clonal hematopoiesis in the donor does not adversely affect long-term outcomes following allogeneic hematopoietic stem cell transplantation: result from a 13-year follow-up

Author

Kim, Kyoung Ha, primary, Kim, TaeHyung, additional, Novitzky-Basso, Igor, additional, Lee, Hyewon, additional, Yoo, Youngseok, additional, Ahn, Jae-Sook, additional, Pasic, Ivan, additional, Law, Arjun, additional, Lam, Wilson, additional, Michelis, Fotios V., additional, Gerbitz, Armin, additional, Viswabandya, Auro, additional, Lipton, Jeffrey, additional, Kumar, Rajat, additional, Mattsson, Jonas, additional, Zhang, Zhaolei, additional, Kaushansky, Nathali, additional, Brilon, Yardena, additional, Chapal-Ilani, Noa, additional, Biezuner, Tamir, additional, Shlush, Liran I, additional, and Kim, Dennis Dong Hwan, additional

Published
2023
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