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Double-blind, placebo controlled, randomized, multicenter, phase II study to assess the efficacy of the high affinity CXCR4 inhibitor BL-8040 as addition to consolidation therapy in AML by the ASL and OSHO Leukemia Study Groups [Abstract] (2022)
Jaramillo Segura, Sonia ; Wass, Maxi ; Schaffrath, Judith ; Rieger, Kathrin ; Nogai, Axel ; Hänel, Mathias ; Herbst, Regina ; Stölzel, Friedrich ; Röllig, Christoph ; Jost, Edgar ; Schlenk, Richard F. ; Noppeney, Richard ; Brandts, Christian H. ; Krug, Utz ; Götze, Katharina S. ; Buske, Sebastian ; Florschütz, Axel ; Schubert, Jörg ; Opitz, Bernhard ; Mohren, Martin ; Eßeling, Eva ; von Witzendorff, Stephan ; Subklewe, Marion ; Kaufmann, Martin ; Frickhofen, Norbert ; Scholz, Christian W. ; Schäfer-Eckart, Kerstin ; Kunzmann, Volker ; Schmidt-Hieber, Martin ; Sayer, Herbert G. ; Rank, Andreas ; Hemmati, Philipp ; Schüler, Frank ; Kowoll, Simone ; Scheller, Marina ; Steighardt, Jörg ; Edemir, Bayram ; Müller, Lutz Peter ; Gliko-Kabir, Irit ; Ludwig-Kraus, Beatrice ; Edemir, Sabine ; Sorani, Ella ; Binder, Mascha ; Vainstein, Abi ; Kadosh, Shaul ; Gromann, Cora ; Wienke, Andreas ; Baldus, Claudia D. ; Platzbecker, Uwe ; Serve, Hubert ; Bornhäuser, Martin ; Junghanss, Christian ; Müller-Tidow, Carsten
Haploidentical second allogeneic hematopoietic stem cell transplantation for the treatment of acute leukemia relapse after first Allo-HSCT: a retrospective registry analysis of 60 patients on behalf of the German Cooperative Transplant Group (2014)
Christopeit, Maximilian ; Tischer, Johanna ; Bornhäuser, Martin ; Uharek, Lutz ; Pfrepper, Christian ; Behre, Gerhard ; Niederwieser, Dietger ; Kröger, Nicolaus ; Rösler, Wolf ; Klein, Stefan A. ; Beelen, Dietrich ; Hausmann, Andreas ; Bethge, Wolfgang ; Schmid, Christoph
Allogeneic hematopoietic cell transplantation in acute myeloid leukemia with intermediate-risk: results of the randomized ETAL-1 trial (2022)
Bornhauser, Martin ; Schliemann, Christoph ; Schetelig, Johannes ; Röllig, Christoph ; Kramer, Michael ; Glass, Bertram ; Platzbecker, Uwe ; Burchert, Andreas ; Hänel, Mathias ; Muller, Lutz ; Klein, Stefan ; Bug, Gesine ; Beelen, Dietrich ; Rösler, Wolf ; Schäfer-Eckart, Kerstin ; Schmid, Christoph ; Jost, Edgar ; Lenz, Georg ; Tischer, Johanna ; Spiekermann, Karsten ; Pfirrmann, Markus ; Serve, Hubert ; Stölzel, Friedrich ; Alakel, Nael ; Middeke, Jan Moritz ; Thiede, Christian ; Ehninger, Gerhard ; Berdel, Wolfgang ; Stelljes, Matthias
Management of patients undergoing CAR-T cell therapy in Germany (2024)
Penack, Olaf ; Dreger, Peter ; Ajib, Salem ; Ayuk, Francis ; Baermann, Ben-Niklas ; Bug, Gesine ; Kriege, Oliver ; Jentzsch, Madlen ; Kobbe, Guido ; Koenecke, Christian ; Lutz, Mathias ; Martin, Sonja ; Schlegel, Paul-Gerhard ; Schroers, Roland ; von Tresckow, Bastian ; Vucinic, Vladan ; Subklewe, Marion ; Bethge, Wolfgang ; Wolff, Daniel
Introduction: Chimeric antigen receptor positive T cell (CAR-T cell) treatment became standard therapy for relapsed or refractory hematologic malignancies, such as non-Hodgkin’s lymphoma and multiple myeloma. Owing to the rapidly progressing field of CAR-T cell therapy and the lack of generally accepted treatment guidelines, we hypothesized significant differences between centers in the prevention, diagnosis, and management of short- and long-term complications. Methods: To capture the current CAR-T cell management among German centers to determine the medical need and specific areas for future clinical research, the DAG-HSZT (Deutsche Arbeitsgemeinschaft für Hämatopoetische Stammzelltransplantation und Zelluläre Therapie; German Working Group for Hematopoietic Stem Cell Transplantation and Cellular Therapy) performed a survey among 26 German CAR-T cell centers. Results: We received answers from 17 centers (65%). The survey documents the relevance of evidence in the CAR-T cell field with a homogeneity of practice in areas with existing clinical evidence. In contrast, in areas with no – or low quality – clinical evidence, we identified significant variety in management in between the centers: management of cytokine release syndrome, immune effector cell-related neurotoxicity syndrome, IgG substitution, autologous stem cell backups, anti-infective prophylaxis, and vaccinations. Conclusion: The results indicate the urgent need for better harmonization of supportive care in CAR-T cell therapies including clinical research to improve clinical outcome.
Does size outweigh number in predicting survival after pulmonary metastasectomy for soft tissue sarcoma? Insights from a retrospective multicenter study (2025)
Burkhard-Meier, Anton ; Grube, Matthias ; Jurinovic, Vindi ; Agaimy, Abbas ; Albertsmeier, Markus ; Berclaz, Luc M. ; Di Gioia, Dorit ; Dürr, Hans Roland ; von Eisenhart-Rothe, Rüdiger ; Eze, Chukwuka ; Fechner, Katja ; Fey, Emma ; Güler, Sinan E. ; Hecker, Judith S. ; Hendricks, Anne ; Keil, Felix ; Klein, Alexander ; Knebel, Carolin ; Kovács, Julia R. ; Kunz, Wolfgang G. ; Lenze, Ulrich ; Lörsch, Alisa M. ; Lutz, Mathias ; Meidenbauer, Norbert ; Mogler, Carolin ; Schmid, Sebastian ; Schmidt-Hegemann, Nina-Sophie ; Schneider, Christian ; Semrau, Sabine ; Sienel, Wulf ; Trepel, Martin ; Waldschmidt, Johannes ; Wiegering, Armin ; Lindner, Lars H.
Background: Pulmonary metastasectomy (PM) is the most frequently performed local ablative therapy for leiomyosarcoma (LMS), synovial sarcoma (SyS), and undifferentiated pleomorphic sarcoma (UPS). This study aimed to assess surgical feasibility, outcome, and clinical prognostic factors, as well as the value of a peri-interventional systemic therapy. Methods: This multicenter retrospective study enrolled 77 patients with LMS, SyS, or UPS who underwent first-time complete resection of isolated lung metastases between 2009 and 2021. Disease-free survival (DFS), overall survival (OS), and clinical prognostic factors were analyzed. Results: After the first PM, the median DFS was 7.4 months, and the median OS was 58.7 months. A maximal lesion diameter greater than 2 cm was associated with reduced DFS in both the univariable (hazard ratio [HR], 2.29; p = 0.006) and multivariable (HR, 2.60; p = 0.005) analyses. The univariable analysis identified a maximal lesion diameter greater than 2 cm as an adverse prognostic factor for OS (HR, 5.6; p < 0.001), whereas a treatment-free interval longer than 12 months was associated with improved OS (HR, 0.42; p = 0.032). The addition of systemic therapy was associated with a trend toward improved DFS for patients with lesions larger than 2 cm (HR, 0.29; p = 0.063). Severe postoperative complications (grade ≥IIIa) occurred in 2 % of the patients. Conclusion: The size of resected lung metastases might be a more relevant prognostic factor than their number for patients with LMS, SyS, or UPS. For patients with lung metastases larger than 2 cm in maximal diameter, additional systemic therapy may be warranted.
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