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1. Therapeutic strategies and treatment sequencing in patients with chronic lymphocytic leukemia: An international study of ERIC, the European Research Initiative on CLL

Author

Thomas Chatzikonstantinou, Lydia Scarfò, Eva Minga, Georgios Karakatsoulis, Dimitra Chamou, Jana Kotaskova, Gloria Iacoboni, Christos Demosthenous, Elisa Albi, Miguel Alcoceba, Salem Al‐Shemari, Thérèse Aurran‐Schleinitz, Francesca Bacchiarri, Sofia Chatzileontiadou, Rosa Collado, Zadie Davis, Marcos Daniel deDeus Santos, Maria Dimou, Elena Dmitrieva, David Donaldson, Gimena Dos Santos, Barbara Dreta, Maria Efstathopoulou, Shaimaa El‐Ashwah, Alicia Enrico, Andrzej Frygier, Sara Galimberti, Andrea Galitzia, Eva Gimeno, Valerio Guarente, Romain Guieze, Sean Harrop, Eleftheria Hatzimichael, Yair Herishanu, José‐Ángel Hernández‐Rivas, Ozren Jaksic, Elżbieta Kalicińska, Kamel Laribi, Volkan Karakus, Arnon P. Kater, Bonnie Kho, Maria Kislova, Εliana Konstantinou, Maya Koren‐Michowitz, Ioannis Kotsianidis, Zuzana Kubova, Jorge Labrador, Deepesh Lad, Luca Laurenti, Thomas Longval, Alberto Lopez‐Garcia, Juan Marquet, Stanislava Maslejova, Carlota Mayor‐Bastida, Biljana Mihaljevic, Ivana Milosevic, Fatima Miras, Riccardo Moia, Marta Morawska, Uttam K. Nath, Almudena Navarro‐Bailón, Jacopo Olivieri, Irina Panovska‐Stavridis, Maria Papaioannou, Cheyenne Pierie, Anna Puiggros, Gianluigi Reda, Gian M. Rigolin, Rosa Ruchlemer, Mattia Schipani, Annett Schiwitza, Yandong Shen, Tereza Shokralla, Martin Simkovic, Svetlana Smirnova, Dina S. A. Soliman, Stephan Stilgenbauer, Tamar Tadmor, Kristina Tomic, Eric Tse, Theodoros Vassilakopoulos, Andrea Visentin, Candida Vitale, George Vrachiolias, Vojin Vukovic, Renata Walewska, Zhenshu Xu, Munci Yagci, Lucrecia Yañez, Mohamed Yassin, Jana Zuchnicka, David Oscier, Alessandro Gozzetti, Panagiotis Panagiotidis, Francesc Bosch, Paolo Sportoletti, Blanca Espinet, Gerassimos A. Pangalis, Viola M. Popov, Stephen Mulligan, Maria Angelopoulou, Fatih Demirkan, Tomas Papajík, Bella Biderman, Roberta Murru, Marta Coscia, Constantine Tam, Antonio Cuneo, Gianluca Gaidano, Rainer Claus, Niki Stavroyianni, Livio Trentin, Darko Antic, Lukas Smolej, Olga B. Kalashnikova, Mark Catherwood, Martin Spacek, Sarka Pospisilova, Michael Doubek, Eugene Nikitin, Anastasia Chatzidimitriou, Paolo Ghia, and Kostas Stamatopoulos

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2024
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2. Other malignancies in the history of CLL: an international multicenter study conducted by ERIC, the European Research Initiative on CLL, in HARMONYResearch in context

Author

Thomas Chatzikonstantinou, Lydia Scarfò, Georgios Karakatsoulis, Eva Minga, Dimitra Chamou, Gloria Iacoboni, Jana Kotaskova, Christos Demosthenous, Lukas Smolej, Stephen Mulligan, Miguel Alcoceba, Salem Al-Shemari, Thérèse Aurran-Schleinitz, Francesca Bacchiarri, Mar Bellido, Fontanet Bijou, Anne Calleja, Angeles Medina, Mehreen Ali Khan, Ramona Cassin, Sofia Chatzileontiadou, Rosa Collado, Amy Christian, Zadie Davis, Maria Dimou, David Donaldson, Gimena Dos Santos, Barbara Dreta, Maria Efstathopoulou, Shaimaa El-Ashwah, Alicia Enrico, Alberto Fresa, Sara Galimberti, Andrea Galitzia, Rocío García-Serra, Eva Gimeno, Isabel González-Gascón-y-Marín, Alessandro Gozzetti, Valerio Guarente, Romain Guieze, Ajay Gogia, Ritu Gupta, Sean Harrop, Eleftheria Hatzimichael, Yair Herishanu, José-Ángel Hernández-Rivas, Luca Inchiappa, Ozren Jaksic, Susanne Janssen, Elżbieta Kalicińska, Laribi Kamel, Volkan Karakus, Arnon P. Kater, Bonnie Kho, Maria Kislova, Eliana Konstantinou, Maya Koren-Michowitz, Ioannis Kotsianidis, Robert J. Kreitman, Jorge Labrador, Deepesh Lad, Mark-David Levin, Ilana Levy, Thomas Longval, Alberto Lopez-Garcia, Juan Marquet, Lucia Martin-Rodríguez, Marc Maynadié, Stanislava Maslejova, Carlota Mayor-Bastida, Biljana Mihaljevic, Ivana Milosevic, Fatima Miras, Riccardo Moia, Marta Morawska, Roberta Murru, Uttam Kumar Nath, Almudena Navarro-Bailón, Ana C. Oliveira, Jacopo Olivieri, David Oscier, Irina Panovska-Stavridis, Maria Papaioannou, Tomas Papajík, Zuzana Kubova, Punyarat Phumphukhieo, Cheyenne Pierie, Anna Puiggros, Lata Rani, Gianluigi Reda, Gian Matteo Rigolin, Rosa Ruchlemer, Marcos Daniel de Deus Santos, Mattia Schipani, Annett Schiwitza, Yandong Shen, Martin Simkovic, Svetlana Smirnova, Dina Sameh Abdelrahman Soliman, Martin Spacek, Tamar Tadmor, Kristina Tomic, Eric Tse, Theodoros Vassilakopoulos, Andrea Visentin, Candida Vitale, Julia von Tresckow, George Vrachiolias, Vojin Vukovic, Renata Walewska, Ewa Wasik-Szczepanek, Zhenshu Xu, Munci Yagci, Lucrecia Yañez, Mohamed Yassin, Jana Zuchnicka, Maria Angelopoulou, Darko Antic, Bella Biderman, Mark Catherwood, Rainer Claus, Marta Coscia, Antonio Cuneo, Fatih Demirkan, Blanca Espinet, Gianluca Gaidano, Olga B. Kalashnikova, Luca Laurenti, Eugene Nikitin, Gerassimos A. Pangalis, Panagiotis Panagiotidis, Viola Maria Popov, Sarka Pospisilova, Paolo Sportoletti, Niki Stavroyianni, Constantine Tam, Livio Trentin, Anastasia Chatzidimitriou, Francesc Bosch, Michael Doubek, Paolo Ghia, and Kostas Stamatopoulos

Subjects
Chronic lymphocytic leukemia, Other malignancies, Other cancers, Second primary malignancies, Medicine (General), R5-920
Abstract

Summary: Background: Patients with chronic lymphocytic leukemia (CLL) have a higher risk of developing other malignancies (OMs) compared to the general population. However, the impact of CLL-related risk factors and CLL-directed treatment is still unclear and represents the focus of this work. Methods: We conducted a retrospective international multicenter study to assess the incidence of OMs and detect potential risk factors in 19,705 patients with CLL, small lymphocytic lymphoma, or high-count CLL-like monoclonal B-cell lymphocytosis, diagnosed between 2000 and 2016. Data collection took place between October 2020 and March 2022. Findings: In 129,254 years of follow-up after CLL diagnosis, 3513 OMs were diagnosed (27.2 OMs/1000 person-years). The most common hematological OMs were Richter transformation, myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Non-melanoma skin (NMSC) and prostate cancers were the most common solid tumors (STs).The only predictor for MDS and AML development was treatment with fludarabine and cyclophosphamide with/without rituximab (FC ± R) (OR = 3.7; 95% CI = 2.79–4.91; p

Published
2023
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3. S149: OTHER MALIGNANCIES IN THE HISTORY OF CLL: THE FINAL ANALYSIS OF THE INTERNATIONAL MULTICENTER STUDY CONDUCTED BY ERIC, IN HARMONY.

Author

Thomas Chatzikonstantinou, Lydia Scarfò, Georgios Karakatsoulis, Eva Minga, Dimitra Chamou, Gloria Iacoboni, Jana Kotaskova, Christos Demosthenous, Miguel Alcoceba, Salem Al-Shemari, Thérèse Aurran-Schleinitz, Francesca Bacchiarri, Mar Bellido, Fontanet Bijou, Anne Calleja, Angeles Medina, Mehreen Ali Khan, Ramona Cassin, Sofia Chatzileontiadou, Rosa Collado, Zadie Davis, Maria Dimou, David Donaldson, Gimena Dos Santos, Barbara Dreta, Maria Efstathopoulou, Shaimaa El-Ashwah, Alicia Enrico, Alberto Fresa, Sara Galimberti, Andrea Galitzia, Rocío García-Serra, Eva Gimeno, Isabel González-Gascón-Y-Marín, Alessandro Gozzetti, Valerio Guarente, Romain Guieze, Ajay Gogia, Ritu Gupta, Sean Harrop, Eleftheria Hatzimichael, Yair Herishanu, José-Ángel Hernández-Rivas, Luca Inchiappa, Ozren Jaksic, Susanne Janssen, Elżbieta Kalicińska, Laribi Kamel, Volkan Karakus, Arnon P Kater, Bonnie Kho, Maria Kislova, Εliana Konstantinou, Maya Koren-Michowitz, Ioannis Kotsianidis, Robert J Kreitman, Jorge Labrador, Deepesh Lad, Mark-David Levin, Ilana Levy, Thomas Longval, Alberto Lopez-Garcia, Juan Marquet, Marc Maynadié, Stanislava Maslejova, Carlota Mayor-Bastida, Biljana Mihaljevic, Ivana Milosevic, Fatima Miras, Riccardo Moia, Marta Morawska, Roberta Murru, Uttam Kumar Nath, Almudena Navarro-Bailón, Ana C. Oliveira, Jacopo Olivieri, David Oscier, Irina Panovska-Stavridis, Maria Papaioannou, Tomas Papajík, Punyarat Phumphukhieo, Cheyenne Pierie, Anna Puiggros, Lata Rani, Gianluigi Reda, Gian Matteo Rigolin, Aharon Ronson, Rosa Ruchlemer, Marcos Daniel de Deus Santos, Mattia Schipani, Annett Schiwitza, Yandong Shen, Martin Simkovic, Svetlana Smirnova, Dina Sameh Abdelrahman Soliman, Martin Spacek, Tamar Tadmor, Kristina Tomic, Eric Tse, Theodoros Vassilakopoulos, Andrea Visentin, Candida Vitale, Julia von Tresckow, George Vrachiolias, Vojin Vukovic, Renata Walewska, Ewa Wasik-Szczepanek, Zhenshu Xu, Munci Yagci, Lucrecia Yañez, Mohamed Yassin, Jana Zuchnicka, Maria Angelopoulou, Darko Antic, Bella Biderman, Mark Catherwood, Rainer Claus, Marta Coscia, Antonio Cuneo, Fatih Demirkan, Blanca Espinet, Gianluca Gaidano, Olga Kalashnikova, Luca Laurenti, Eugene Nikitin, Gerassimos A. Pangalis, Panagiotis Panagiotidis, Stephen Mulligan, Viola Maria Popov, Sarka Pospisilova, Lukas Smolej, Paolo Sportoletti, Niki Stavroyianni, Constantine Tam, Livio Trentin, Anastasia Chatzidimitriou, Francesc Bosch, Michael Doubek, Paolo Ghia, and Kostas Stamatopoulos

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2023
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4. A third anti-SARS-CoV-2 mRNA dose does not overcome the pejorative impact of anti-CD20 therapy and/or low immunoglobulin levels in patients with lymphoma or chronic lymphocytic leukemia

Author

Milena Kohn, Marc Delord, Maureen Chbat, Amina Guemriche, Fatiha Merabet, Anne-Laure Roupie, Naelle Lombion, Hassan Farhat, Thomas Longval, Aurélie Cabannes-Hamy, Juliette Lambert, Stéphanie Marque-Juillet, Victoria Raggueneau, Jennifer Osman, Marc Spentchian, Sophie Rigaudeau, Philippe Rousselot, and Caroline Besson

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Published
2021
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5. Successful mRNA SARS-Cov-2 vaccine rechallenge after a first episode of immune thrombocytopenic purpura

Author

Mathilde Chanut, Rym Jaidi, Milena Kohn, Thomas Grange, Clara Brones, Naëlle Lombion, Philippe Rousselot, and Thomas Longval

Subjects
immune thrombocytopenic purpura, mrna sars cov2 vaccine, rechallenge, Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

In 2021, the world experienced the most extensive vaccination campaign to defeat COVID-19. Many cases of idiopathic thrombocytopenia have been reported following injections of SARS-Cov-2 mRNA vaccine. We present the case of a 73-year-old woman with de novo ITP after a first injection of SARS-Cov-2 mRNA vaccine (Moderna vaccine) who experienced a successful rechallenge of SARS-Cov-2 mRNA vaccine (Pfizer vaccine) a few months later.

Published
2022
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6. Guideline adherence and survival of patients with candidaemia in Europe: results from the ECMM Candida III multinational European observational cohort study

Author

Martin Hoenigl, Jon Salmanton-García, Matthias Egger, Jean-Pierre Gangneux, Tihana Bicanic, Sevtap Arikan-Akdagli, Ana Alastruey-Izquierdo, Nikolai Klimko, Aleksandra Barac, Volkan Özenci, Eelco F J Meijer, Nina Khanna, Matteo Bassetti, Riina Rautemaa-Richardson, Katrien Lagrou, Kai-Manuel Adam, Emin Halis Akalin, Murat Akova, Valentina Arsic Arsenijevic, Avinash Aujayeb, Ola Blennow, Stéphane Bretagne, François Danion, Blandine Denis, Nick Alexander de Jonge, Guillaume Desoubeaux, Lubos Drgona, Nurettin Erben, Andrea Gori, Julio García Rodríguez, Carolina Garcia-Vidal, Daniele Roberto Giacobbe, Anna L Goodman, Petr Hamal, Helena Hammarström, Cristina Toscano, Fanny Lanternier, Cornelia Lass-Flörl, Deborah E A Lockhart, Thomas Longval, Laura Loughlin, Tadeja Matos, Malgorzata Mikulska, Manjusha Narayanan, Sonia Martín-Pérez, Juergen Prattes, Benedict Rogers, Laman Rahimli, Maite Ruiz, Emmanuel Roilides, Michael Samarkos, Ulrike Scharmann, Uluhan Sili, Oguz Resat Sipahi, Alena Sivakova, Joerg Steinmann, Janina Trauth, Ozge Turhan, Jens Van Praet, Antonio Vena, P Lewis White, Birgit Willinger, Anna Maria Tortorano, Maiken C Arendrup, Philipp Koehler, Oliver A Cornely, Mario Tumbarello, Alida Fe Talento, Alba C Ruiz, Zdenek Racil, Igor Stoma, Maria Calbacho, Eric Van Wijngaerden, Júlia Henriques, Harriett Jordan, Valentina Ferroni, Ozlem Koyuncu Ozyurt, Christopher Milacek, Robert Krause, Christoph Zurl, Matthijs Backx, Ang Li, Raphael Seufert, Rok Tomazin, Yael Blankenheim, Julio Dávila-Valls, Paloma García-Clemente, Tomas Freiberger, Jochem Buil, Jacques F Meis, Deniz Akyol, Hélène Guegan, Clare Logan, Medical University of Graz, University of Cologne, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Pontchaillou [Rennes], Scynexis, Hoenigl M., Salmanton-García J., Egger M., Gangneux J., Bicanic T., Arikan-Akdagli S., Alastruey-Izquierdo A., Klimko N., Barac A., Özenci V., et al., and Hematology

Subjects
MESH: Humans, İmmünoloji, Temel Bilimler, Settore MED/42 - Igiene Generale e Applicata, Medizin, Life Sciences, Life Sciences (LIFE), MESH: Adult, INFECTIOUS DISEASES, Sağlık Bilimleri, MESH: Antifungal Agents, MESH: Candidemia, IMMUNOLOGY, Bulaşıcı hastalıklar, Yaşam Bilimleri (LIFE), BULAŞICI HASTALIKLAR, MESH: Candida, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Yaşam Bilimleri, Health Sciences, MESH: Guideline Adherence, MESH: Europe, Natural Sciences, MESH: Cohort Studies
Abstract

Background: The European Confederation of Medical Mycology (ECMM) collected data on epidemiology, risk factors, treatment, and outcomes of patients with culture-proven candidaemia across Europe to assess how adherence to guideline recommendations is associated with outcomes. Methods: In this observational cohort study, 64 participating hospitals located in 20 European countries, with the number of eligible hospitals per country determined by population size, included the first ten consecutive adults with culture-proven candidaemia after July 1, 2018, and entered data into the ECMM Candida Registry (FungiScope CandiReg). We assessed ECMM Quality of Clinical Candidaemia Management (EQUAL Candida) scores reflecting adherence to recommendations of the European Society of Clinical Microbiology and Infectious Diseases and the Infectious Diseases Society of America guidelines. Findings: 632 patients with candidaemia were included from 64 institutions. Overall 90-day mortality was 43% (265/617), and increasing age, intensive care unit admission, point increases in the Charlson comorbidity index score, and Candida tropicalis as causative pathogen were independent baseline predictors of mortality in Cox regression analysis. EQUAL Candida score remained an independent predictor of mortality in the multivariable Cox regression analyses after adjusting for the baseline predictors, even after restricting the analysis to patients who survived for more than 7 days after diagnosis (adjusted hazard ratio 1·08 [95% CI 1·04–1·11; p

Published
2023
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7. Anti-CD19 CAR T-Cell Therapy for Patients with Richter Syndrome: A Lysa Study from the Descar-T Registry

Author

Hedi Bensaber, Emmanuel Bachy, David Beauvais, Remy Dulery, Thomas Gastinne, Bruno Villemagne, Louise Roulin, Etienne Paubelle, Cristina Castilla-Llorente, Thomas Longval, Elodie Gat, Amandine Fayard, Jacques-Olivier Bay, Steven Le Gouill, Roch Houot, Romain Guieze, CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), CHU Lille, Service d'hématologie clinique et de thérapie cellulaire [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon (CHD Vendée), CHU Henri Mondor, CHU Amiens-Picardie, Institut Gustave Roussy (IGR), Centre Hospitalier de Versailles André Mignot (CHV), The Lymphoma Academic Research Organisation [Lyon] (LYSARC), Institut Curie [Paris], CHU Pontchaillou [Rennes], and DESSAIVRE, Louise

Subjects
[SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Immunology, Cell Biology, Hematology, Biochemistry, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

International audience; Background Richter syndrome (RS) refers to the onset of aggressive lymphoma, mostly diffuse large B-cell lymphoma (DLBCL), in patients with chronic lymphocytic leukemia (CLL). The outcome of RS patients is usually very poor with short survival (typically 2. Tocilizumab was administered to 9 (75%) patients. Five (42%) patients had ICANS, 3 (25%) with grade > 3. Regarding hematotoxicity, 6 (50%) patients presented with grade > 2 thrombocytopenia, 5 (42%) with grade > 2 anemia, and 7 with (58%) grade > 2 neutropenia. One case of macrophage activation syndrome was reported. Three patients were admitted to intensive care. A total of 5 (42%) patients had infections. After a median follow-up of 1.6 months (range, 0-23), 8 (67%) patients were alive, 4 (33%) patients died (2 from CRS and 2 from disease progression).Conclusions CD19-directed CAR T-cell therapy showed high response rates in our series of heavily pretreated RS patients. Frequency of CAR T-cell-specific adverse events was in the range of what is observed in de novo DLBCL while severity appeared higher (Schuster et al., NEJM 2019; Neelapu et al., NEJM 2017). Larger cohort with longer follow-up and prospective trials are warranted to confirm these observations.

Published
2022
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8. AML-262 Pivekimab Sunirine (PVEK, IMGN632) triplet with azacitidine and venetoclax shows broad activity in adverse genetic subsets of relapsed/refractory acute myeloid leukemia and reduced infusion-related reactions

Author

Naval Daver, Pau Montesinos, Ahmed Aribi, Giovanni Martinelli, Jessica K. Altman, Eunice S. Wang, Gail J. Roboz, Patrick W. Burke, Gianluca Gaidano, Roland B. Walter, Xavier Thomas, Deepa Jeyakumar, Daniel J. DeAngelo, Harry P. Erba, Elisabetta Todisco, Kebede Begna, Anjali Advani, Lauris Gastaud, Adolfo de la Fuente, Antonio Curti, Lourdes M. Mendez, Paresh Vyas, Nicolas Boissel, Norbert Vey, Christian Recher, Thomas Longval, Uwe Platzbecker, Silke Kapp-Schwörer, Christoph Schliemann, Marina Konopleva, Laura Torres, David A. Sallman, Guido Marcucci, Giovanni Marconi, Hagop Kantarjian, Callum M. Sloss, Karen E. Malcolm, Patrick A. Zweidler-McKay, and Kendra Sweet

Subjects
Cancer Research, Oncology, Hematology
Abstract

Context: Pivekimab sunirine (PVEK, IMGN632) is a first-in-class ADC comprising a CD123 high-affinity antibody, a cleavable linker, and an IGN (indolinobenzodiazepine pseudodimer) payload. PVEK with azacitidine (AZA) and venetoclax (VEN) is a novel triplet that has demonstrated anti-leukemia activity in relapsed/refractory AML patients. Objective: Evaluate the anti-leukemia activity in genetic subgroups of AML and safety of the triplet. Intervention: Patients with relapsed/refractory AML received PVEK+AZA+VEN in a three-drug escalation over a 28-day cycle: PVEK 0.015 or 0.045 mg/kg day 7, AZA 50 or 75 mg/m2 days 1–7, and VEN 400 mg for 8, 14, or 21 days. Results: Twenty-nine patients (median age 67 y, ELN adverse 62%, prior VEN 48%) were in higher-intensity cohorts (PVEK 0.045 mg/kg and/or VEN for 14 or 21 days). The overall response rate (ORR) was 59% (4 CR, 6 CRh, 1 CRp, 6 MLFS) and the composite complete remission rate (CCR, CR+CRh+CRp+CRi) was 38%. Higher rates are seen in patients with FLT3-ITD (n=9, ORR 89%, CCR 78%), IDH2 (n=4, ORR 75%, CCR 75%), and WT1 (n=7, ORR 57%, CCR 43%) mutations. Lower rates are seen in patients with monosomy 7/abn7q (n=6, ORR 17%, CCR 17%), TP53 (n=4, ORR 25%, CCR 25%), and ASXL1 (n=6, ORR 67%, CCR 17%) deletions or mutations. The safety profile for the PVEK triplet is similar to AZA+VEN. No VOD, TLS, or CRS was reported. IRRs were reported in 33% (n=17, one grade 4) of patients given 1 dose of dexamethasone (8 mg) as premedication (n=51); these IRRs were most frequently tachycardia and chills, with no anaphylactic reactions reported. Following the data cut-off, there was a second grade 4 IRR, and the prophylactic regimen was increased with two additional doses of dexamethasone on the day prior to the PVEK dose. The IRR rate has dropped to 8% (3 of 38), with no grade 3+; all were grades 1–2 that resolved with limited intervention (P Conclusions: The PVEK triplet with AZA+VEN demonstrates anti-leukemic activity across multiple high-risk genetic subsets of relapsed/refractory AML. Prophylactic steroids added on day –1 have significantly reduced IRRs. Expansion cohorts are now enrolling for untreated and relapsed AML patients (NCT04086264).

Published
2022
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