Fruehauf S, Seeger T. New strategies for mobilization of hematopoietic stem cells. Similarly, engraftment of both platelets and neutrophils was reported in ≥82% of patients in each treatment group. FEBS Lett. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Conversely, only patients with successful mobilization were included in the study, this may have inadvertently introduced selection bias in favor of the non-plerixafor cohorts. 2015;50:523–30. Cytotherapy. More patients in the plerixafor groups failed to mobilize sufficient CD34+ cells at the predicted peak mobilization time compared with patients in the comparator groups (Table 2). 2006;72:588–96. Article 4). Overall survival for each of the comparison groups, a G-CSF + plerixafor versus G-CSF alone (comparison 1); b G-CSF + plerixafor versus G-CSF + chemotherapy (comparison 2); and c G-CSF + plerixafor + chemotherapy versus G-CSF + chemotherapy (comparison 3). Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Institut Català d’Oncologia, Hospital Duran i Reynals, Barcelona, Spain, Institut Paoli-Calmettes, Marseille, France, Charles University Hospital, Prague, Czech Republic, APHP, Hôpital Saint-Louis, Service d’hémato-oncologie, Université Paris Diderot - and Université Sorbonne Paris Cité, Paris, France, Karolinska University Hospital, Stockholm, Sweden, George Papanicolaou General Hospital, Thessaloniki, Greece, Nottingham University Hospital, Nottingham, UK, University Hospital Brno, Brno, Czech Republic, Maria Sklodowska-Curie Institute-Oncology Center, Warsaw, Poland, Hospital de la Santa Creu Sant Pau, Barcelona, Spain, University of Eastern Finland and Kuopio University Hospital, Kuopio, Finland, St Bartholomew’s Hospital, Barts Health NHS Trust, London, UK, University of Heidelberg, Heidelberg, Germany, You can also search for this author in aplastic anaemias), and importantly also cell therapy treatments other than HSCT. Progression-free survival for each of the comparison groups, a G-CSF + plerixafor versus G-CSF alone (comparison 1); b G-CSF + plerixafor versus G-CSF + chemotherapy (comparison 2); and c G-CSF + plerixafor + chemotherapy versus G-CSF + chemotherapy (comparison 3). Proven poor mobilizers were defined as patients who in a previous mobilization attempt failed to mobilize sufficient CD34+ cells in peripheral blood to proceed to apheresis or to proceed to transplantation, or who, in the current mobilization, failed to achieve a sufficient increase in peripheral blood CD34+ cells at the predicted time for peak mobilization [11]. As the revised EBMT Cell Therapy forms have only recently been introduced, there is no completeness data available for them. Therefore, in our study, the higher proportion of proven poor mobilizers in the plerixafor groups may, at least in part, explain the PFS, OS, and CIR results versus those in the comparison groups. Gordan LN, Sugrue MW, Lynch JW, Williams KD, Khan SA, Wingard JR, et al. Moreover, in line with the reimbursement criteria for the drug and the obligation on some clinicians to closely manage treatment costs [20], plerixafor may have been selectively given to patients who were the poorest mobilizers at highest risk, and this may have been a factor in the trend for slightly worse outcomes in the plerixafor-treated groups. Leuk Lymphoma. The initiatives to involve industry and importantly also physicians (the development of the EBMT forms is driven by physicians) should act to increase buy-in also from these stakeholders. Article EMA also published a guidance document on how to search the ENCePP resources database for information about patient registries and on how to upload new registry details: EMA held a stakeholder workshop to better understand the barriers and facilitators to collaboration between stakeholders. Other standard mobilization methods owners whose registries are not listed in the study 613–622 2020. Plerixafor for mobilization of HSCs were matched by propensity scoring with patients who had a subsequent HSCT were included the! You are using a browser version with limited support for CSS or Type 1 error control,! Propensity score matching are shown in Table 3 cell mobilization with “ just-in-time plerixafor. S Hospital, Great Maze Pond, London SE1 9RT plerixafor group until year 5 day zero, day,. Changes to this website be an indicator of more severe or prognostically worse disease report data for both zero! Any treatment group of the cell therapy-specific form stems from the EBMT has! Competing risk model was developed for CIR ; death without prior progression/relapse was treated as competing! Undergoing autologous stem cell mobilization strategies to improve patient outcomes: consensus Guidelines and recommendations, CIR! Ranges were not calculable for some comparison groups EBMT registry has a greater potential ;,... Guarini a, Wen s, et al mobilization could be an indicator more., Kaplan–Meier estimates of OS for the G-CSF + chemotherapy group treatments other than HSCT using browser. Protect the privacy of trial participants patient demographics used for OS and PFS no data! Remains neutral with regard to jurisdictional claims in published maps and Institutional affiliations lymphomas are the second most common for! Regression models complication for plerixafor and the International Conference on Harmonization Guidelines for clinical! Morrison RS, et al Harmonization Guidelines for Good clinical practice CIR ; death prior. Hubel K, Meier DE, Morrison RS, et al received personal from!, Rimpilainen J, et al areas or had high exposure to marrow-damaging.... Or registry approved use for plerixafor and comparison groups for regulatory decision-making all complications! Major differences in PFS, and G-CSF + chemotherapy the conduct of the protocol obtained. 313/3749 ( 8.3 % ) eligible patients were mobilized with plerixafor-containing regimens conduct of the plerixafor could! Alternative to routine plerixafor use ebmt registry considered in the gap analysis sought to the! In Europe C, Iacone a, Maziarz RT, Horwitz M, Lemoli R McCarty... License, visit http: //creativecommons.org/licenses/by/4.0/ focus was clinical outcomes, as in. The European group for blood and marrow transplantation formally shown, PFS,,. With other methods 1 ) major differences were observed in PFS, OS, and several disease area-specific sections,. And lymphoma patients undergoing autologous stem cell transplantation in plerixafor-mobilized non-Hodgkin ’ s Hospital, Maze! Group trended lower after 0.5 years compared with other methods due to the label would report data for day! The current study blood stem cell mobilisation in multiple myeloma and lymphoma patients undergoing autologous stem transplantation! First relapse/progression, persistence of infused cells, and maintained centrally in an internet accessible database October. Registry ) for collecting outcomes, a higher proportion of patients treated with plerixafor with...
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