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2. Treatment and outcome of 2904 CML patients from the EUTOS population-based registry

Author

Hoffmann, V S, Baccarani, M, Hasford, J, Castagnetti, F, Di Raimondo, F, Casado, L F, Turkina, A, Zackova, D, Ossenkoppele, G, Zaritskey, A, Höglund, M, Simonsson, B, Indrak, K, Sninska, Z, Sacha, T, Clark, R, Bogdanovic, A, Hellmann, A, Griskevicius, L, Schubert-Fritschle, G, Sertic, D, Guilhot, J, Lejniece, S, Zupan, I, Burgstaller, S, Koskenvesa, P, Everaus, H, Costeas, P, Lindoerfer, D, Rosti, G, Saussele, S, Hochhaus, A, and Hehlmann, R

Published
2017
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3. The EUTOS population-based registry: incidence and clinical characteristics of 2904 CML patients in 20 European Countries

Author

Hoffmann, V S, Baccarani, M, Hasford, J, Lindoerfer, D, Burgstaller, S, Sertic, D, Costeas, P, Mayer, J, Indrak, K, Everaus, H, Koskenvesa, P, Guilhot, J, Schubert-Fritschle, G, Castagnetti, F, Di Raimondo, F, Lejniece, S, Griskevicius, L, Thielen, N, Sacha, T, Hellmann, A, Turkina, A G, Zaritskey, A, Bogdanovic, A, Sninska, Z, Zupan, I, Steegmann, J-L, Simonsson, B, Clark, R E, Covelli, A, Guidi, G, and Hehlmann, R

Published
2015
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4. Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study

Author

Hochhaus, A, Rosti, G, Cross, N CP, Steegmann, J L, le Coutre, P, Ossenkoppele, G, Petrov, L, Masszi, T, Hellmann, A, Griskevicius, L, Wiktor-Jedrzejczak, W, Rea, D, Coriu, D, Brümmendorf, T H, Porkka, K, Saglio, G, Gastl, G, Müller, M C, Schuld, P, Di Matteo, P, Pellegrino, A, Dezzani, L, Mahon, F-X, Baccarani, M, and Giles, F J

Published
2016
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5. Correction: Redefining and measuring transplant conditioning intensity in current era: a study in acute myeloid leukemia patients (Bone Marrow Transplantation, (2020), 55, 6, (1114-1125), 10.1038/s41409-020-0803-y)

Author

Spyridonidis A., Labopin M., Savani B. N., Niittyvuopio R., Blaise D., Craddock C., Socie G., Platzbecker U., Beelen D., Milpied N., Cornelissen J. J., Ganser A., Huynh A., Griskevicius L., Giebel S., Aljurf M., Brissot E., Malard F., Esteve J., Peric Z., Baron F., Ruggeri A., Schmid C., Gilleece M., Gorin N. -C., Lanza F., Shouval R., Versluis J., Bug G., Floisand Y., Ciceri F., Sanz J., Bazarbachi A., Nagler A., Mohty M., Spyridonidis, A., Labopin, M., Savani, B. N., Niittyvuopio, R., Blaise, D., Craddock, C., Socie, G., Platzbecker, U., Beelen, D., Milpied, N., Cornelissen, J. J., Ganser, A., Huynh, A., Griskevicius, L., Giebel, S., Aljurf, M., Brissot, E., Malard, F., Esteve, J., Peric, Z., Baron, F., Ruggeri, A., Schmid, C., Gilleece, M., Gorin, N. -C., Lanza, F., Shouval, R., Versluis, J., Bug, G., Floisand, Y., Ciceri, F., Sanz, J., Bazarbachi, A., Nagler, A., and Mohty, M.

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

10. Significantly higher and more rapid cytogenetic and molecular responses can be achieved in pre-treated chronic phase CML patients with high doses of Imatinib as induction therapy (800 mg/day, 6 months) - final results of a Phase III CELSG CML11 “ISTAHIT” TRIAL: V278

Author

Petzer, A. L., Fong, D., Lion, T., Dyagil, I., Masliak, Z., Bogdanovic, A., Griskevicius, L., Lejniece, S., Goranov, S., Gercheva, L., Stojanovic, A., Peytchev, D., Tzetkov, N., Griniute, R., Oucheva, R., Grubinger, T., Kwakkelstein, M., Rancati, F., Gastl, G., and Wolf, D.

Published
2010

14. S238: MATCHED RELATED VERSUS UNRELATED VERSUS HAPLOIDENTICAL DONORS FOR ALLOGENEIC TRANSPLANTATION IN AML PATIENTS ACHIEVING FIRST COMPLETE REMISSION AFTER TWO INDUCTION COURSES: A STUDY FROM THE ALWP/EBMT.

Author

Nagler, A., Labopin, M., Mielke, S., Passweg, J., Blaise, D., Gedde‐Dahl, T., Cornelissen, J. J., Salmenniemi, U., Yakoub‐Agha, I., Reményi, P., Socié, G., Van Gorkom, G., Labussière‐Wallet, H., Huang, X.‐J., Thérèse Rubio, M., Byrne, J. L, Craddock, C., Griskevicius, L., Ciceri, F., and Mohty, M.

Published
2022
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15. S125: 10‐DAY DECITABINE VS. CONVENTIONAL CHEMOTHERAPY (“3 + 7”) FOLLOWED BY ALLOGRAFTING (HSCT) IN AML PATIENTS ≥60 YEARS: A RANDOMIZED PHASE III STUDY OF THE EORTC LEUKEMIA GROUP, GIMEMA, CELG, AND GMDS‐SG.

Author

Lübbert, M., Wijermans, P., Kicinski, M., Chantepie, S., van der Velden, W., Noppeney, R., Griskevicius, L., Neubauer, A., Crysandt, M., Vrhovac, R., Luppi, M., Fuhrmann, S., Audisio, E., Candoni, A., Legrand, O., Foà, R., Gaidano, G., van Lammeren‐Venema, D., Posthuma, E. F., and Hoogendoorn, M.

Published
2022
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16. Efficacy and safety of pegylated full-length recombinant factor VIII with extended half-life for perioperative haemostasis in haemophilia A patients.

Author

Brand, B., Gruppo, R., Wynn, T. T., Griskevicius, L., Lopez Fernandez, M. F., Chapman, M., Dvorak, T., Pavlova, B. G., and Abbuehl, B. E.

Subjects
HEMOPHILIACS, HEMOPHILIA treatment, PATIENT management, POSTOPERATIVE care, SURGERY, MANAGEMENT
Abstract

Introduction BAX 855 is a pegylated full-length recombinant factor VIII ( rFVIII) with an extended half-life, built on a licensed rFVIII ( ADVATE®). BAX 855 demonstrated efficacy and safety in prophylaxis and the treatment of bleeding episodes in previously treated patients (PTPs) with severe haemophilia A. Aim This phase 3 surgery study evaluates the haemostatic efficacy and safety of BAX 855 for perioperative haemostasis in PTPs with severe haemophilia A undergoing surgery. Methods Elective procedures were prospectively classified as major or minor. The dose and frequency of BAX 855 administered perioperatively were to be guided by each patient's pharmacokinetic profile for major procedures or BAX 855 incremental recovery for minor procedures. Haemostatic efficacy was evaluated using a predefined scale. Blood loss was compared to the expected average and maximum blood loss predicted preoperatively. Results A total of 15 male patients (aged 19-52 years) underwent 15 procedures (11 major and four minor). The overall intra- and perioperative haemostatic efficacy of BAX 855 was 'excellent' in all 15 subjects (100%). Postoperatively, evaluated at postoperative Day 1, all treatments were 'excellent' except for one minor (dental) procedure which was rated 'good'. No related adverse events, allergic reactions, thrombotic events, nor signs of immunogenicity in terms of induction of binding antibodies to FVIII, PEG or PEG- VIII, or FVIII inhibitors were observed. Conclusion These results demonstrate that BAX 855 is safe and haemostatically effective in patients with severe haemophilia A undergoing surgery. [ABSTRACT FROM AUTHOR]

Published
2016
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23. Clear cell sarcoma expressing a novel chimerical transcript EWSR1 exon 7/ATF1 exon 6.

Author

Gineikiene E, Seinin D, Brasiuniene B, Brazaitis A, Griskevicius L, Jakubauskas A, Gineikiene, Egle, Seinin, Dmitrij, Brasiuniene, Birute, Brazaitis, Andrius, Griskevicius, Laimonas, and Jakubauskas, Arturas

Abstract

Clear cell sarcoma harbours recurrent translocation, resulting in EWSR1/ATF1 or less commonly EWSR1/CREB1 fusion. To date, six types of EWSR1/ATF1 fusion have been reported, of which three are in-frame and encode functional proteins. We present a reverse transcription - polymerase chain reaction analysis of a tumour near the hallux of the right foot. The sequencing of obtained fragments revealed the presence of a novel chimerical transcript-the in-frame fusion between EWSR1 exon 7 and ATF1 exon 6 that represents the fourth in-frame type of EWSR1/ATF1 fusion identified in clear cell sarcomas. [ABSTRACT FROM AUTHOR]

Published
2012
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26. XM02, the first granulocyte colony-stimulating factor biosimilar, is safe and effective in reducing the duration of severe neutropenia and incidence of febrile neutropenia in patients with non-Hodgkin lymphoma receiving chemotherapy.

Author

Engert, A., Griskevicius, L., Zyuzgin, Y., Lubenau, H., and del Giglio, A.

Subjects
*COLONY-stimulating factors (Physiology), *GRANULOCYTES, *DRUG therapy, *NEUTROPENIA, *HODGKIN'S disease, *GRANULOCYTE antigens
Abstract

Recombinant granulocyte colony-stimulating factors (G-CSFs) such as filgrastim or lenograstim are being used to treat chemotherapy-induced neutropenia. The aim of the present study was to investigate a new G-CSF, XM02, in comparison to filgrastim in terms of safety and efficacy in the prevention of chemotherapy-induced neutropenia in non-Hodgkin-lymphoma (NHL). A total of 92 patients receiving chemotherapy were randomised in cycle 1 to treatment with daily injections (subcutaneous 5 µg/kg/day) of XM02 (n = 63) or filgrastim (n = 29) for at least 5 days and a maximum of 14 days. In subsequent cycles, all patients received XM02. The mean duration of severe neutropenia (DSN) was 0.5 and 0.9 days in cycle 1 for XM02 and filgrastim, respectively (p = 0.1055). In cycle 1, the incidence of febrile neutropenia (FN) was 11.1% for XM02 and 20.7% for filgrastim (p = 0.1232). The adverse event profile was similar between XM02 and filgrastim. XM02 demonstrated equivalent efficacy and similar safety profile as the reference medication filgrastim. Treatment with XM02 is as beneficial as filgrastim in ameliorating severe neutropenia and FN in patients with NHL receiving chemotherapy. XM02 is safe and well tolerated in the doses applied in this study. [ABSTRACT FROM AUTHOR]

Published
2009
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28. Two novel HLA‐C alleles, HLA‐C*02:02:34 and HLA‐C*03:369, were identified in the same individual.

Author

Valatkaite‐Rakstiene, B., Cekauskiene, R., Griskevicius, L., and Jakubauskas, A.

Subjects
HLA histocompatibility antigens, ALLELES, BONE marrow cells, STEM cell donors, HEMATOLOGY, PHYSIOLOGY
Abstract

Summary: Two new HLA class I alleles, HLA‐C*02:02:34 and HLA‐C*03:369, were characterized in a single Polish bone marrow donor. [ABSTRACT FROM AUTHOR]

Published
2018
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29. Identification of a novel allele, HLA-A*03:289, by sequence-based typing in Lithuanian patient.

Author

Valatkaite-Rakstiene, B., Cekauskiene, R., Griskevicius, L., and Jakubauskas, A.

Subjects
HLA histocompatibility antigen genetics, HISTOCOMPATIBILITY class I antigens, NUCLEOTIDE sequence, MAJOR histocompatibility complex, IMMUNOGLOBULIN receptors, IMMUNOGLOBULIN genetics
Abstract

Amino acid substitution Val165Leu of the HLA-A*03:01:01 results in a novel allele, HLA-A*03:289. [ABSTRACT FROM AUTHOR]

Published
2018
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31. Pre-operative high sensitive C-reactive protein predicts cardiovascular events after coronary artery bypass grafting surgery: A prospective observational study

Author

Balciunas Mindaugas, Bagdonaite Loreta, Samalavicius Robertas, Griskevicius Laimonas, and Vuylsteke Alain

Subjects
C reactive protein, coronary artery bypass grafting surgery, cardiovascular events, Anesthesiology, RD78.3-87.3, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

C-reactive protein is a powerful independent predictor of cardiovascular events in patients with coronary artery disease. The relation between C-reactive protein (CRP) concentration and in-hospital outcome, after coronary artery bypass grafting (CABG), has not yet been established. The study aims to evaluate the predictive value of pre-operative CRP for in-hospital cardiovascular events after CABG surgery. High-sensitivity CRP (hs-CRP) levels were measured pre-operatively on the day of surgery in 66 patients scheduled for elective on pump CABG surgery. Post-operative cardiovascular events such as death from cardiovascular causes, ischemic stroke, myocardial damage, myocardial infarction and low output heart failure were recorded. During the first 30 days after surgery, 54 patients were free from observed events and 14 developed the following cardiovascular events: 10 (15%) had myocardial damage, four (6%) had low output heart failure and two (3%) suffered stroke. No patients died during the follow-up period. Serum concentration of hs-CRP ≥ 3.3 mg/l (cut-off point obtained by ROC analysis) was related to higher risk of post-operative cardiovascular events (36% vs 6%, P = 0.01), myocardial damage (24% vs 6%, P = 0.04) and low output heart failure (12% vs 0%, P = 0.04). Multivariate logistic regression analysis showed that hs-CRP ≥ 3.3 mg/l ( P = 0.002, O.R.: 19.3 (95% confidence interval (CI) 2.9-128.0)), intra-operative transfusion of red blood cells ( P = 0.04, O.R.: 9.9 (95% C.I. 1.1-85.5)) and absence of diuretics in daily antihypertensive treatment ( P = 0.02, O.R.: 15.1 (95% C.I. 1.4-160.6) were independent predictors of combined cardiovascular event. Patients having hs-CRP value greater or equal to 3.3 mg/l pre-operatively have an increased risk of post-operative cardiovascular events after on pump coronary artery bypass grafting surgery.

Published
2009

33. Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study

Author

Hochhaus, A., Rosti, G., Cross, N. C. P., Steegmann, J. L., Le Coutre, Philipp, Ossenkoppele, G., Petrov, L., Masszi, T., Hellmann, A., Griskevicius, L., Wiktor-Jedrzejczak, W., Rea, D., Coriu, D., Brümmendorf, Tim Henrik, Porkka, K., Saglio, G., Gastl, G., Müller, M. C., Schuld, P., Di Matteo, P., Pellegrino, A., Dezzani, L., Mahon, F.-X., Baccarani, M., and Giles, F. J.

Subjects
3. Good health
Abstract

Leukemia : normal and malignant hemopoiesis 30(1), 57-64 (2016). doi:10.1038/leu.2015.270, Published by Nature Publ. Group, Basingstoke

38. Identification of a novel HLA-B allele, B*56:31, by sequence-based typing in a Lithuanian individual.

Author

Jakubauskas, A., Vilkeviciene, R., Juskevicius, D., and Griskevicius, L.

Subjects
HLA histocompatibility antigens, EXONS (Genetics), NUCLEOTIDE sequence, GENETIC code, GENETIC mutation, LITHUANIANS, HUMAN genetics
Abstract

A novel allele HLA-B*56:31 differs from HLA-B*56:18 by three nucleotide substitutions resulting in a missense mutation Tyr171His (TAC to CAC) encoded in exon 3 and two silent substitutions at codon 188His (CAC to CAT) and codon 228Thr (ACT to ACC) encoded in exon 4. [ABSTRACT FROM AUTHOR]

Published
2011
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39. Sequence-based typing showed a novel HLA-DQB1*05 allele, DQB1*05:01:03.

Author

Jakubauskas, A. and Griskevicius, L.

Subjects
*NUCLEOTIDE sequence, *MAJOR histocompatibility complex, *NUCLEIC acid analysis, *NUCLEOTIDE analysis, *IMMUNOGENETICS, *ANTIGENS
Abstract

The novel allele HLA-DQB1*05:01:03 differs from HLA-DQB1*05:01:01 by a silent nucleotide substitution at codon 77R (AGG to AGA). [ABSTRACT FROM AUTHOR]

Published
2011
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40. Haplotype-specific sequencing reveals a novel HLA-A*03 allele, A*030114.

Author

Jakubauskas, A. and Griskevicius, L.

Subjects
*POPULATION genetics, *NUCLEOTIDE sequence, *HLA histocompatibility antigens, *BONE marrow transplantation, *POLYMERASE chain reaction
Abstract

The novel allele HLA-A*030114 differs from HLA-A*03010101 by a silent nucleotide substitution at codon 153A (GCG to GCA). [ABSTRACT FROM AUTHOR]

Published
2010
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41. Post-transplant cyclophosphamide versus antithymocyte globulin in patients with acute myeloid leukemia in first complete remission undergoing allogeneic stem cell transplantation from 10/10 HLA-matched unrelated donors

Author

Gwendolyn Van Gorkom, Montserrat Rovira, Edouard Forcade, Myriam Labopin, Eolia Brissot, Annalisa Ruggeri, Alexandros Spyridonidis, Eric Deconinck, Martin Mistrik, Jan J. Cornelissen, Claude Eric Bulabois, Ian Moiseev, Ellen Meijer, Stephan Mielke, Laimonas Griskevicius, Sebastian Giebel, Didier Blaise, Riitta Niittyvuopio, Bipin N. Savani, Fabio Ciceri, Arnon Nagler, Jaime Sanz, Mohamad Mohty, Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Hematology, Centre de Recherche Saint-Antoine (CRSA), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Sorbonne Université (SU), 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), CEREST-TC [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Pavlov First Saint Petersburg State Medical University [St. Petersburg], Erasmus University Medical Center [Rotterdam] (Erasmus MC), VU University Medical Center [Amsterdam], Maastricht University Medical Centre (MUMC), Maastricht University [Maastricht], University of Barcelona, IRCCS Ospedale San Raffaele [Milan, Italy], Universita Vita Salute San Raffaele = Vita-Salute San Raffaele University [Milan, Italie] (UniSR), Vilnius University [Vilnius], Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Hôpital Haut-Lévêque [CHU Bordeaux], CHU Bordeaux [Bordeaux], Comenius University in Bratislava, University Hospital of Würzburg, Centre Hospitalier Universitaire [Grenoble] (CHU), Hôpital JeanMinjoz, Universitat de València (UV), General University Hospital of Patras, Vanderbilt University Medical Center [Nashville], Vanderbilt University [Nashville], Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology (MCMCC), Gestionnaire, Hal Sorbonne Université, Centre de Recherche Saint-Antoine (CR Saint-Antoine), Sorbonne Université (SU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Aix Marseille Université (AMU), HUS Comprehensive Cancer Center, Clinicum, Department of Oncology, Brissot, E., Labopin, M., Moiseev, I., Cornelissen, J. J., Meijer, E., Van Gorkom, G., Rovira, M., Ciceri, F., Griskevicius, L., Blaise, D., Forcade, E., Mistrik, M., Mielke, S., Bulabois, C. E., Niittyvuopio, R., Deconinck, E., Ruggeri, A., Sanz, J., Spyridonidis, A., Savani, B., Giebel, S., Nagler, A., Mohty, M., RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Hematologie (9), CCA - Cancer Treatment and quality of life, and CHU Saint-Antoine [AP-HP]

Subjects
Oncology, Male, Cancer Research, BLOOD, [SDV]Life Sciences [q-bio], MULTICENTER, Graft vs Host Disease, Kaplan-Meier Estimate, HEMATOLOGICAL MALIGNANCIES, PROPHYLAXIS, 0302 clinical medicine, antithymocyte globulin, prevention, Recurrence, immune system diseases, Cause of Death, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, skin allograft tolerance, Medicine, Cumulative incidence, ComputingMilieux_MISCELLANEOUS, free survival, Hematology, Incidence (epidemiology), Incidence, Graft Survival, Remission Induction, Hematopoietic Stem Cell Transplantation, Myeloid leukemia, lcsh:Diseases of the blood and blood-forming organs, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Allografts, Combined Modality Therapy, 3. Good health, [SDV] Life Sciences [q-bio], Leukemia, Myeloid, Acute, surgical procedures, operative, 030220 oncology & carcinogenesis, Histocompatibility, [SDV.IMM]Life Sciences [q-bio]/Immunology, Female, Post-transplant cyclophosphamide, Unrelated Donors, Immunosuppressive Agents, medicine.drug, Adult, medicine.medical_specialty, Cyclophosphamide, Adolescent, post-transplant cyclophosphamide, 3122 Cancers, matched unrelated donor, Human leukocyte antigen, acute myeloid leukemia, open-label, lcsh:RC254-282, Disease-Free Survival, MECHANISMS, versus-host-disease, 03 medical and health sciences, Young Adult, Internal medicine, Humans, Matched unrelated donor, Propensity Score, Molecular Biology, Aged, Antilymphocyte Serum, Retrospective Studies, Acute myeloid leukemia, business.industry, lcsh:RC633-647.5, Research, Transplantation, Propensity score matching, Antithymocyte globulin, business, 030215 immunology
Abstract

International audience; Full text linksfull-text provider logoActionsFavoritesSharePage navigation Title & authors Abstract Conflict of interest statement Figures References Related information LinkOut - more resourcesJ Hematol Oncol. 2020 Jul 3;13(1):87.doi: 10.1186/s13045-020-00923-0.Post-transplant cyclophosphamide versus antithymocyte globulin in patients with acute myeloid leukemia in first complete remission undergoing allogeneic stem cell transplantation from 10/10 HLA-matched unrelated donorsEolia Brissot 1 2 , Myriam Labopin 3 , Ian Moiseev 4 , J J Cornelissen 5 , Ellen Meijer 6 , Gwendolyn Van Gorkom 7 , Montserrat Rovira 8 , Fabio Ciceri 9 10 , Laimonas Griskevicius 11 , Didier Blaise 12 , Edouard Forcade 13 , Martin Mistrik 14 , Stephan Mielke 15 , Claude Eric Bulabois 16 , Riitta Niittyvuopio 17 , Eric Deconinck 18 , Annalisa Ruggeri 9 10 , Jaime Sanz 19 20 , Alexandros Spyridonidis 21 , Bipin Savani 22 , Sebastian Giebel 23 , Arnon Nagler 24 , Mohamad Mohty 25 26Affiliations PMID: 32620146 PMCID: PMC7333262 DOI: 10.1186/s13045-020-00923-0 Free PMC articleAbstractBackground: Graft-versus-host disease (GVHD) remains a major contributor to mortality and morbidity after allogeneic stem-cell transplantation (allo-HSCT). The updated recommendations suggest that rabbit antithymocyte globulin or anti-T-lymphocyte globulin (ATG) should be used for GVHD prophylaxis in patients undergoing matched-unrelated donor (MUD) allo-HSCT. More recently, using post-transplant cyclophosphamide (PTCY) in the haploidentical setting has resulted in low incidences of both acute (aGVHD) and chronic GVHD (cGVHD). Therefore, the aim of our study was to compare GVHD prophylaxis using either PTCY or ATG in patients with acute myeloid leukemia (AML) who underwent allo-HSCT in first remission (CR1) from a 10/10 HLA-MUD.Methods: Overall, 174 and 1452 patients from the EBMT registry receiving PTCY and ATG were included. Cumulative incidence of aGVHD and cGVHD, leukemia-free survival, overall survival, non-relapse mortality, cumulative incidence of relapse, and refined GVHD-free, relapse-free survival were compared between the 2 groups. Propensity score matching was also performed in order to confirm the results of the main analysis RESULTS: No statistical difference between the PTCY and ATG groups was observed for the incidence of grade II-IV aGVHD. The same held true for the incidence of cGVHD and for extensive cGVHD. In univariate and multivariate analyses, no statistical differences were observed for all other transplant outcomes. These results were also confirmed using matched-pair analysis.Conclusion: These results highlight that, in the10/10 HLA-MUD setting, the use of PTCY for GVHD prophylaxis may provide similar outcomes to those obtained with ATG in patients with AML in CR1.

Published
2020
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42. The Effect of Therapeutic Plasma Exchange on the Bioavailability of Interferon Beta. Pilot Study.

Author

Giedraitiene, N., Kizlaitiene, R., Budrys, V., Kaubrys, G., Griskevicius, L., Valceckiene, V., Stoskus, M., Griskevicius, A., and Audzijoniene, J.

Subjects
*PLASMA exchange (Therapeutics), *INTERFERONS, *DRUG bioavailability, *IMMUNOGLOBULINS, *MULTIPLE sclerosis treatment, *MESSENGER RNA, *GENE expression
Abstract

Back ground and purpose. The development of neutralizing antibodies (NAbs) against interferon beta (IFN-β) during IFN-β treatment in multiple sclerosis (MS) patients has been a significant clinical problem. Persistent, high-titer NAbs-IFN-β reduce or eliminate biological activity of IFN-β therapies for MS and are associated with reduction in efficacy. Therapeutic plasma exchange (TPE) removes the circulating antibodies that are thought to be active in the diseases, so we hypothesized that TPE can restore the ability of IFN-β to induce the Myxovirus Resistance Protein A (MxA) mRNA expression and the maintenance plasmapheresis can sustain the bioavailability of IFN-β. Methods. Eligible patients under went primarily four separate plasma exchange sessions and after the induction TPE sessions they were transferred to the maintenance plasma pheresis. Bioactivity of interferon beta was expressed as in vivo MxA mRNA induction in whole blood using real time PCR. Results. Six patients with RRMS and low IFN-β bioavailability detected by the MxA mRNA response were included. Four patients after induction plasmapheresis be came biological responders. In two patients an in crease of MxA mRNA expression was found, but the values persisted be low the cut-off and the patients remained as "poor biological responders". The effect of maintenance plasmapheresis was quite transient: MxA mRNA expression values reverted to the base line levels after one or two months. Conclusion. Plasma exchange may restore the bioavailability of IFN-β in some patients, but the effect of maintenance plasmapheresis on the bioavailability of IFN-β is transient. [ABSTRACT FROM AUTHOR]

Published
2013

43. Repurposed Antiviral Drugs for Covid-19 - Interim WHO Solidarity Trial Results

Author

Carlos Guijarro, Farid Zand, Mohamed solyman Kabil, Sven Trelle, Birgitte Tholin, Belén Comeche, Johan Alexander Azañero Haro, Gonzalo Sierra Torres, Quarraisha Abdool Karim, Kari Tikkinen, Jean-michel Molina, Atousa Hakamifard, George M Varghese, Oscar Josue Ponce Ponte, Mazin Barry, Pilar Vizcarra, Niccolo Riccardi, Natalia Pérez-Macias, Aynaa AlSharidi, Nelson Lee, Alexandra Binnie, Firouzé BANI-SADR, Beatriz Díaz-Pollán, Aldo Pietro Maggioni, Ilkka Kalliala, Florian Desgranges, Anders Benjamin Kildal, Katerina Nezvalova-Henriksen, Corinne Merle, Andrés Martín Alcántara, Benjamin Gaborit, Daniel Lozano Martín, Antonio Ramos-Martinez, Miguel Villegas-Chiroque, Fredy Orlando Guevara Pulido, Ana Fernández-Cruz, Cormac McCarthy, Thesla Palanee-Phillips, Annalisa Marinosci, Abdullah Assiri, Florent Wallet, Juan Pablo Balbuena, Avik Ray, Francesc Puchades, Rajarao Mesipogu, Marjatta Sinisalo, Jonathan Sterne, Antonio Portolés, Heike Cappel-Porter, Jussi Mustonen, Jeremy Nel, BRUNO MOURVILLIER, María Consuelo Miranda Montoya, Chiara Fanciulli, L Marjukka Myllärniemi, Edinson Dante Meregildo Rodriguez, Alexy Inciarte, Mohamed Hassany, François Danion, Elena Muñez Rubio, Jean-Pierre QUENOT, Esperanza Merino de Lucas, Sheela Godbole, Luis Guillermo Barreto Rocchetti, Katerina Spasovska, William Connors, Kiana Shirani, Umang Agrawal, Srinivas Murthy, Bjorn Blomberg, Vasee Moorthy, Amith Balachandran, Antonio De Pablo Esteban, Mahnaz Amini, Dag Arne Lihaug Hoff, Zeinab Siami, Guillaume Martin-Blondel, Heng Gee Lee, Thrilok Chander Bingi, Vijay Krishnan, ANA BELEN RIVAS PATERNA, Eric D'Ortenzio, Samy Zaky, Carlos Arturo Alvarez-Moreno, Alonso Soto, VIKAS MARWAH, Marco Tulio Medina, Zaira R. Palacios-Baena, Jean-Sébastien Hulot, Miguel Angel Hueda Zavaleta, Felipe García, Francisco Fanjul, Hospices Civils de Lyon (HCL), INSERM UMR-S 606, Hôpital Lariboisière, Assistance Publique-Hôpitaux de Paris, PRES Sorbonne Paris-Cité, and Université Paris Denis Diderot, Université Paris Diderot - Paris 7 (UPD7), Michel-Avella, Amandine, Pan, H., Peto, R., Henao-Restrepo, A. -M., Preziosi, M. -P., Sathiyamoorthy, V., Karim, Q. A., Alejandria, M. M., Garcia, C. H., Kieny, M. -P., Malekzadeh, R., Murthy, S., Srinath Reddy, K., Periago, M. R., Hanna, P. A., Ader, F., Al-Bader, A. M., Alhasawi, A., Allum, E., Alotaibi, A., Alvarez-Moreno, C. A., Appadoo, S., Asiri, A., Aukrust, P., Barratt-Due, A., Bellani, S., Branca, M., Cappel-Porter, H. B. C., Cerrato, N., Chow, T. S., Como, N., Eustace, J., Garcia, P. J., Godbole, S., Gotuzzo, E., Griskevicius, L., Hamra, R., Hassan, M., Hassany, M., Hutton, D., Irmansyah, I., Jancoriene, L., Kirwan, J., Kumar, S., Lennon, P., Lopardo, G., Lydon, P., Magrini, N., Maguire, T., Manevska, S., Manuel, O., Mcginty, S., Medina, M. T., Mesa Rubio, M. L., Miranda-Montoya, M. C., Nel, J., Nunes, E. P., Perola, M., Portoles, A., Rasmin, M. R., Raza, A., Rees, H., Reges, P. P. S., Rogers, C. A., Salami, K., Salvadori, M. I., Sinani, N., Sterne, J. A. C., Stevanovikj, M., Tacconelli, E., Tikkinen, K. A. O., Trelle, S., Zaid, H., Rottingen, J. -A., Swaminathan S., &amp, Luzzati, R, Di Bella, S, Doctoral Programme in Population Health, Doctoral Programme in Biomedicine, HUS Abdominal Center, Department of Surgery, Urologian yksikkö, South Carelia Social and Health care District Eksote, HUS Heart and Lung Center, Department of Medicine, Clinicum, Department of Obstetrics and Gynecology, HUS Gynecology and Obstetrics, UCL - SSS/IREC/LTAP - Louvain Centre for Toxicology and Applied Pharmacology, and UCL - (SLuc) Service de médecine interne générale

Subjects
Male, Kaplan Meier method, Intention to Treat Analysi, MESH: Treatment Failure, MESH: Hydroxychloroquine, remdesivir, Rate ratio, MESH: Intention to Treat Analysis, MESH: Length of Stay, law.invention, Lopinavir/*therapeutic use, 0302 clinical medicine, middle aged, Medicine, Hospital Mortality, MESH: Respiration, Artificial, Antiviral Agents/administration & dosage/adverse effects/*therapeutic use, comparative study, beta1a interferon, MESH: Middle Aged, Alanine, Respiration, adult, clinical trial, General Medicine, 3. Good health, Intention to Treat Analysis, [SDV] Life Sciences [q-bio], aged, health care quality, priority journal, drug withdrawal, Artificial, Interferon, Drug Therapy, Combination, medicine.medical_specialty, Initiation of ventilation, Interferon beta-1a/*therapeutic use, World Health Organization, Antiviral Agents, Article, Duration of hospital stay, antiviral drugs, 03 medical and health sciences, Drug Therapy, death, Humans, MESH: Hospital Mortality, human, MESH: Kaplan-Meier Estimate, Aged, MESH: Humans, treatment duration, extracorporeal oxygenation, Hydroxychloroquine, Length of Stay, major clinical study, mortality, Respiration, Artificial, Adenosine Monophosphate/*analogs & derivatives/therapeutic use, multicenter study, Alanine/*analogs & derivatives/therapeutic use, MESH: Interferon beta-1a, randomized controlled trial, MESH: Female, antivirus agent, [SDV]Life Sciences [q-bio], MESH: Hospitalization, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Lopinavir, Adenosine Monophosphate, COVID-19, Female, Hospitalization, Interferon beta-1a, Middle Aged, Treatment Failure, Randomized controlled trial, Interquartile range, law, MESH: COVID-19, MESH: Adenosine Monophosphate, 030212 general & internal medicine, antiviral drugs, Covid-19, MESH: Aged, Hydroxychloroquine/*therapeutic use, MESH: Lopinavir, Covid19, artificial ventilation, drug therapy, ritonavir, hospital patient, female, Combination, medicine.drug, MESH: Antiviral Agents, combination drug therapy, COVID-19/*drug therapy/mortality, Randomization, MESH: Alanine, drug repositioning, drug clearance, adenosine phosphate, coronavirus disease 2019, length of stay, Internal medicine, controlled study, Antiviral Agent, Intention-to-treat analysis, business.industry, MESH: Male, COVID-19 Drug Treatment, purl.org/pe-repo/ocde/ford#3.02.00 [https], MESH: Drug Therapy, Combination, 3121 General medicine, internal medicine and other clinical medicine, business
Abstract

The authors report interim results of the WHO Solidarity trial of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with Covid-19. Effects on overall mortality, initiation of ventilation, and duration of hospital stay are compared. Background World Health Organization expert groups recommended mortality trials of four repurposed antiviral drugs - remdesivir, hydroxychloroquine, lopinavir, and interferon beta-1a - in patients hospitalized with coronavirus disease 2019 (Covid-19). Methods We randomly assigned inpatients with Covid-19 equally between one of the trial drug regimens that was locally available and open control (up to five options, four active and the local standard of care). The intention-to-treat primary analyses examined in-hospital mortality in the four pairwise comparisons of each trial drug and its control (drug available but patient assigned to the same care without that drug). Rate ratios for death were calculated with stratification according to age and status regarding mechanical ventilation at trial entry. Results At 405 hospitals in 30 countries, 11,330 adults underwent randomization; 2750 were assigned to receive remdesivir, 954 to hydroxychloroquine, 1411 to lopinavir (without interferon), 2063 to interferon (including 651 to interferon plus lopinavir), and 4088 to no trial drug. Adherence was 94 to 96% midway through treatment, with 2 to 6% crossover. In total, 1253 deaths were reported (median day of death, day 8; interquartile range, 4 to 14). The Kaplan-Meier 28-day mortality was 11.8% (39.0% if the patient was already receiving ventilation at randomization and 9.5% otherwise). Death occurred in 301 of 2743 patients receiving remdesivir and in 303 of 2708 receiving its control (rate ratio, 0.95; 95% confidence interval [CI], 0.81 to 1.11; P=0.50), in 104 of 947 patients receiving hydroxychloroquine and in 84 of 906 receiving its control (rate ratio, 1.19; 95% CI, 0.89 to 1.59; P=0.23), in 148 of 1399 patients receiving lopinavir and in 146 of 1372 receiving its control (rate ratio, 1.00; 95% CI, 0.79 to 1.25; P=0.97), and in 243 of 2050 patients receiving interferon and in 216 of 2050 receiving its control (rate ratio, 1.16; 95% CI, 0.96 to 1.39; P=0.11). No drug definitely reduced mortality, overall or in any subgroup, or reduced initiation of ventilation or hospitalization duration. Conclusions These remdesivir, hydroxychloroquine, lopinavir, and interferon regimens had little or no effect on hospitalized patients with Covid-19, as indicated by overall mortality, initiation of ventilation, and duration of hospital stay. (Funded by the World Health Organization; ISRCTN Registry number, ; ClinicalTrials.gov number, .)

Published
2020
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44. Treatment and outcome of 2 904 CML patients from the EUTOS population based registry

Author

Gert J. Ossenkoppele, Dubravka Sertić, Perttu Koskenvesa, L.F. Casado, Doris Lindoerfer, F. Di Raimondo, Andrzej Hellmann, Andrija Bogdanovic, Verena S. Hoffmann, Irena Preloznik Zupan, Daniela Zackova, Laimonas Griskevicius, Fausto Castagnetti, Karel Indrak, Sonja Burgstaller, Martin Höglund, Michele Baccarani, Andrey Zaritskey, Ruediger Hehlmann, Joelle Guilhot, Paul Costeas, Anna G. Turkina, Sandra Lejniece, Tomasz Sacha, Richard E. Clark, Joerg Hasford, Andreas Hochhaus, Susanne Saussele, Zuzana Sninská, Gabriele Schubert-Fritschle, Hele Everaus, Gianantonio Rosti, Bengt Simonsson, Hoffmann, V.S, Baccarani, M., Hasford, J., Castagnetti, F., Di Raimondo, F., Casado, L.F., Turkina, A., Zackova, D., Ossenkoppele, G., Zaritskey, A., Höglund, M., Simonsson, B., Indrak, K., Sninska, Z., Sacha, T., Clark, R., Bogdanovic, A., Hellmann, A., Griskevicius, L., Schubert-Fritschle, G., Sertic, D., Guilhot, J., Lejniece, S., Zupan, I., Burgstaller, S., Koskenvesa, P., Everaus, H., Costeas, P., Lindoerfer, D., Rosti, G., Saussele, S., Hochhaus, A., Hehlmann, R., CCA - Cancer Treatment and quality of life, and Hematology

Subjects
Adult, Male, medicine.medical_specialty, Cancer Research, Adolescent, Population, 03 medical and health sciences, European LeukemiaNet, Young Adult, 0302 clinical medicine, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Registries, education, Survival analysis, Aged, Aged, 80 and over, education.field_of_study, business.industry, Incidence (epidemiology), Incidence, Imatinib, Hematology, Middle Aged, Survival Analysis, 3. Good health, Surgery, Dasatinib, Clinical trial, Europe, Treatment Outcome, Anesthesiology and Pain Medicine, Oncology, Nilotinib, 030220 oncology & carcinogenesis, Population Surveillance, Female, business, 030215 immunology, medicine.drug, Follow-Up Studies
Abstract

The European Treatment and Outcome Study (EUTOS) population-based registry includes data of all adult patients newly diagnosed with Philadelphia chromosome-positive and/or BCR-ABL1+ chronic myeloid leukemia (CML) in 20 predefined countries and regions of Europe. Registration time ranged from 12 to 60 months between January 2008 and December 2013. Median age was 55 years and median observation time was 29 months. Eighty percent of patients were treated first line with imatinib, and 17% with a second-generation tyrosine kinase inhibitor, mostly according to European LeukemiaNet recommendations. After 12 months, complete cytogenetic remission (CCyR) and major molecular response (MMR) were achieved in 57% and 41% of patients, respectively. Patients with high EUTOS risk scores achieved CCyR and MMR significantly later than patients with low EUTOS risk. Probabilities of overall survival (OS) and progression-free survival for all patients at 12, 24 and 30 months was 97%, 94% and 92%, and 95%, 92% and 90%, respectively. The new EUTOS long-term survival score was validated: the OS of patients differed significantly between the three risk groups. The probability of dying in remission was 1% after 24 months. The current management of patients with tyrosine kinase inhibitors resulted in responses and outcomes in the range reported from clinical trials. These data from a large population-based, patient sample provide a solid benchmark for the evaluation of new treatment policies.

Published
2016
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45. The EUTOS population-based registry : incidence and clinical characteristics of 2904 CML patients in 20 European Countries

Author

G. Guidi, Michele Baccarani, F. Di Raimondo, Gabriele Schubert-Fritschle, Fausto Castagnetti, J-L Steegmann, Bengt Simonsson, A. Covelli, Tomasz Sacha, Irena Preloznik Zupan, Joelle Guilhot, Andrija Bogdanovic, Verena S. Hoffmann, Karel Indrak, Sandra Lejniece, Dubravka Sertić, Ruediger Hehlmann, Sonja Burgstaller, Richard E. Clark, Noortje Thielen, Perttu Koskenvesa, Joerg Hasford, Andrey Zaritskey, Zuzana Sninská, Laimonas Griskevicius, Hele Everaus, Paul Costeas, Anna G. Turkina, Jiří Mayer, Doris Lindoerfer, Andrzej Hellmann, Hematology, CCA - Innovative therapy, Hoffmann, V.S, Baccarani, M., Hasford, J., Lindoerfer, D., Burgstaller, S., Sertic, D., Costeas, P., Mayer, J., Indrak, K., Everaus, H., Koskenvesa, P., Guilhot, J., Schubert-Fritschle, G., Castagnetti, F., Di Raimondo, F., Lejniece, S., Griskevicius, L., Thielen, N., Sacha, T., Hellmann, A., Turkina, A.G., Zaritskey, A., Bogdanovic, A., Sninska, Z., Zupan, I., Steegmann, J.-L., Simonsson, B., Clark, R.E., Covelli, A., Guidi, G., and Hehlmann, R.

Subjects
Adult, Male, Registrie, medicine.medical_specialty, Pediatrics, Cancer Research, Prognosi, Population, Alpha interferon, Follow-Up Studie, Cohort Studies, Young Adult, hemic and lymphatic diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Epidemiology, Medicine, Humans, Registries, Young adult, education, Aged, Aged, 80 and over, education.field_of_study, business.industry, Incidence (epidemiology), Incidence, Medicine (all), Hematology, Middle Aged, medicine.disease, Prognosis, 3. Good health, Europe, Anesthesiology and Pain Medicine, Oncology, Observational study, Female, Cohort Studie, business, Cohort study, Chronic myelogenous leukemia, Follow-Up Studies, Human
Abstract

This population-based registry was designed to provide robust and updated information on the characteristics and the epidemiology of chronic myeloid leukemia (CML). All cases of newly diagnosed Philadelphia positive, BCR-ABL1+ CML that occurred in a sample of 92.5 million adults living in 20 European countries, were registered over a median period of 39 months. 94.3% of the 2904 CML patients were diagnosed in chronic phase (CP). Median age was 56 years. 55.5% of patients had comorbidities, mainly cardiovascular (41.9%). High-risk patients were 24.7% by Sokal, 10.8% by EURO, and 11.8% by EUTOS risk scores. The raw incidence increased with age from 0.39/100,000/year in people 20-29 years old to 1.52 in those >70 years old, and showed a maximum of 1.39 in Italy and a minimum of 0.69 in Poland (all countries together: 0.99). The proportion of Sokal and Euro score high-risk patients seen in many countries indicates that trial patients were not a positive selection. Thus from a clinical point of view the results of most trials can be generalized to most countries. The incidences observed among European countries did not differ substantially. The estimated number of new CML cases per year in Europe is about 6370.

Published
2015
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46. A randomized, open-label, multicentre, phase 2/3 study to evaluate the safety and efficacy of lumiliximab in combination with fludarabine, cyclophosphamide and rituximab versus fludarabine, cyclophosphamide and rituximab alone in subjects with relapsed chronic lymphocytic leukaemia

Author

Awan, Farrukh T, Hillmen, Peter, Hellmann, Andrzej, Robak, Tadeusz, Hughes, Steven G., Trone, Denise, Shannon, Megan, Flinn, Ian W., Byrd, John C., Riveros, Dardo, Pavlovsky, Santiago, Iastrebner, Claudio M., Carney, Dennis A., Deveridge, Sandra, Durrant, Simon, Hahn, Uwe H., Hertzberg, Mark, Leahy, Michael F., David, Ma, Marlton, Paula, Mulligan, Stephen, Opat, Stephen S., Tiley, Campbell, Wickham, Nicholas W., Cannell, Paul, Gatalano, John, Catalano, John, Cull, Gavin, Luen B., To, Hopfinger, Georg, Jager, Ulrich, Linkesch, Werner, Petzer, Andreas, Schwarzmeier, Josef, Steurer, Michael, Greil, Richard, Bememan, Zwi, Bosly, Andre, Bron, Dominique, Janssens, Ann, Offner, Fritz, Van Den Neste, Eric W., Ka Lung, Wu, Van Hoof, Achiel, Maiolino, Angelo, Pinczowski, Helio, Zanichelli, Maria A., Pereira, Juliana, Larratt, Loree, Spaner, David, Howson Jan, Kang, Chen, Christine I., Cantin, Guy, Fernandez, Louis A., Fraser, Graeme, Mayer, Jiri, Trneny, Marek, Jebavy, Ladislav, Bordessoule, Dominique, Lamy, Thierry, Milpied, Noel, Truchan Graczyk, Malgorzata, Eghbali, Houchingue, Karsenti, Jean Michel, Celigny, Philippe Solal, Mans, Le, Cazin, Bruno, Gyan, Emmanuel, Lepretre, Stephane, Bergmann, Lothar, Tsionos, Konstantinos, Lokeshwar, Nilesh M., Agarwal, Mohan B., Ross, Cecil R., Deshmukh, Chetan D., Narayanan, Geetha, Raina, Vinod, Bondarde, Shailesh A., Shah, Bhavin A., Bairey, Osnat, Tikva, Petach, Shvidel, Lev, Ambrosetti, Achille, Rossi, Policlinico G. B., Angelucci, Emanuele, Carella, Angelo M., Massaia, Massimo, Zinzani, Pier L., Caligaris Cappio, Federico, Foa, Roberto, Gaidano, Gianluca, della Caritá, A. O. Maggiore, Leone, Giuseppe, Santoro, Armando, Griskevicius, Laimonas, Jurgutis, Romualdas, Baker, Bartrum W., Hawkins, Timothy, Corbett, Gillian M., Ganly, Peter, D'Souza, Alvyn B., Deptala, Andrzej, Holowiecki, Jerzy, Kloczko, Janusz, Skotnicki, Aleksander, Zdziarska, Barbara, Kyrcz Krzemien, Slawomira, Dmoszynska, Anna, Moreira, Anna, Pereira, Ana P., Colita, Andrei, Moicean, Andreea D., Vasilica, Mariana, Danaila, Catalin, Gheorghita, Emanuil, Pavlov, Vyacheslav V., Rossiev, Viktor A., Konstantinova, Tatiana, Samoilova, Olga S., Novgorod, Nizhniy, Shelekhova, Tatyana, Zaritsky, Andrey Y., Abdulkadyrov, Kudrat M., Zyuzgin, Ilya S., Pristupa, Alexander S., Loscertales, Javier, Vidal, Joan Besalduch, de Mallorca, Palma, Gonzalez, Marcos, Ortuno, Francisco, Giraldo, Pilar, Nathwani, Amit, Agrawal, Samir G., Rule, Simon, Dearden, Claire E., Bloor, Adrian J., Haynes, Andrew, Singer, Charles, Boclek, Robert G., Bosserman, Linda D., Chan, David, Davidson, Sheldon J., Dichmann, Robert A., Farber, Charles, Hart, Lowell, Hermann, Robert, Eddie, Hu, Janakiraman, Nalini, Jonas, William, Liem, Kiem D., Mcintyre, Rosemary E., O'Brien, Susan, Patel, Giribala, Rado, Thomas, Schilder, Russell, Smith, Scott E., Stock, Wendy, Turturro, Francesco, Venugopal, Parameswaran, Anderson, Thomas C., Berry, William, Boyd, Thomas E., Byrd, John, Cooper, Maureen, Flinn, Ian, Gersh, Robert, Gordon, David, Guzley, Gregory J., Wilks, Sharon T., Klein, Andreas, Krauss, John C., Lister, John, Mandell, Lance, Molina, Arthur, Cooper, Barry, Pendergrass, Kelly B., Reeder, Craig, Savin, Michael A., Spitzer, Gary, Tuscano, Joseph M., Vandeventer, Hendrik, Eradat, Herbert A., Masood, Aisha, Mena, Raul, F. T. Awan, P. Hillmen, A. Hellmann, T. Robak, S. G. Hughe, D. Trone, M. Shannon, I. W. Flinn, J. C. Byrd, L. U. C., and Riveros D, Iastrebner CM, Carney DA, Deveridge S, Durrant S, Hahn UH, Hertzberg M, Leahy MF, Ma D, Marlton P, Mulligan S, Opat SS, Tiley C, Wickham NW, Cannell P, Gatalano J, Cull G, B To L, Catalano J, Wickham NW, Hopfinger G, Jager U, Linkesch W, Petzer A, Schwarzmeier J, Steurer M, Greil R, Bememan Z, Bosly A, Bron D, Janssens A, Offner F, Van Den Neste EW, Wu KL, Van Hoof A, Maiolino A, Pinczowski H, Zanichelli MA, Pereira J, Larratt L, Spaner D, Howson-Jan K, Chen CI, Fernandez LA, Fraser G, Mayer J, Trneny M, Jebavy L, Bordessoule D, Lamy T, Milpied N, Eghbali H, Karsenti JM, Celigny PS, Cazin B, Gyan E, Lepretre S, Bergmann L, Tsionos K, Lokeshwar NM, Agarwal MB, Ross CR, Deshmukh CD, Narayanan G, Raina V, Bondarde SA, Shah BA, Bairey O, Ben-Yehuda D, Shvidel L, Ambrosetti A, Angelucci E, Carella AM, Massaia M, Zinzani PL, Caligaris-Cappio F, Foa R, Gaidano G, Leone G, Santoro A, Griskevicius L, Jurgutis R, Baker BW, Hawkins T, Corbett GM, Ganly P, D'Souza AB, Deptala A, Hellmann A, Holowiecki J, Kloczko J, Skotnicki A, Zdziarska B, Robak T, Dmoszynska A, Moreira I, Pereira AP, Colita A, Moicean AD, Gheorghita E, Vasilica M, Pavlov VV, Rossiev VA, Konstantinova T, Samoilova OS, Novgorod N, Shelekhova T, Zaritsky AY, Abdulkadyrov KM, Zyuzgin IS, Pristupa AS, Loscertales J, Casado LF, Gonzalez M, Ortuno F, Giraldo P, Servet M, Nathwani A, Howson-Jan K, Agrawal SG, Hillmen P, Rule S, Dearden CE, Bloor AJ, Haynes A, Singer C, Boclek RG, Bosserman LD, Chan D, Davidson SJ, Dichmann RA, Farber C, Guzley GJ, Hermann R, Hu E, Janakiraman N, Jonas W, Liem KD, Mcintyre RE, O'Brien S, Patel G, Rado T, Schilder R, Smith SE, Stock W, Turturro F, Venugopal P, Berry W, Boyd TE, Byrd J, Cooper M, Flinn I, Gersh R, Gordon D, Wilks ST, Klein A, Krauss JC, Lister J, Mandell L, Molina A, Pendergrass KB, Reeder C, Savin MA, Spitzer G, Tuscano JM, van Deventer H, Eradat HA, Cooper B, Masood A, Mena R.

Subjects
Oncology, Male, Chronic lymphocytic leukaemia, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Pharmacology, Antibodies, Monoclonal, Murine-Derived, Recurrence, hemic and lymphatic diseases, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Medicine, drug therapy, Male, Middle Aged, Recurrence, Vidarabine, Chronic, Aged, 80 and over, Leukemia, Medicine (all), Antibodies, Monoclonal, Hematology, Middle Aged, Adult, Aged, Aged, Lymphocytic, Fludarabine, Tolerability, Small lymphocytic lymphoma, administration /&/ dosage/adverse effects, Female, Humans, Leukemia, Rituximab, Female, Vidarabine, medicine.drug, Adult, Murine-Derived, medicine.medical_specialty, Cyclophosphamide, chemical and pharmacologic phenomena, CD23, Lumiliximab, Aged, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Antibodies, chronic lymphocytic leukaemia, lumiliximab, small lymphocytic lymphoma, Internal medicine, administration /&/ dosage/adverse effects/analogs /&/ derivatives, 80 and over, Antibodie, Adverse effect, Lymphocytic leukaemia, business.industry, administration /&/ dosage/adverse effects, Antibodie, B-Cell, administration /&/ dosage/adverse effects, Cyclophosphamide, Interim analysis, administration /&/ dosage/adverse effects, Antineoplastic Combined Chemotherapy Protocol, business
Abstract

Item does not contain fulltext Lumiliximab is a chimeric monoclonal antibody that targets CD23 on the surface of chronic lymphocytic leukaemia (CLL) B-cells. Early phase clinical studies with lumiliximab alone and in combination with fludarabine, cyclophosphamide and rituximab (FCR) established its potential efficacy and tolerability. The 152CL201 trial [Lumiliximab with fludarabine, cyclophosphamide and rituximab (FCR) versus FCR alone in subjects with relapsed CLL; LUCID] was a phase 2/3, randomized (1:1), open-label, multicentre study of lumiliximab in combination with FCR versus FCR alone in patients with relapsed CLL. Six hundred and twenty-seven patients were randomized to either arm. Overall the combination of lumiliximab with FCR was not significantly better than FCR alone (overall response rate 71% vs. 72%, complete response rate 16% vs. 15%, median progression-free survival 24.6 vs. 23.9 months respectively, for FCR with and without lumiliximab). There was a slightly increased incidence of adverse events with lumiliximab but these increases did not appear to lead to differences in eventual outcomes. An interim analysis failed to show sufficient efficacy of the combination of lumiliximab with FCR. The study was therefore stopped early for lack of efficacy. Despite the eventual outcome, the LUCID trial is one of the largest studies that provides valuable insight into the efficacy and tolerability of FCR as a therapeutic option for patients with relapsed CLL.

Published
2014

48. Decitabine in older patients with AML: quality of life results of the EORTC-GIMEMA-GMDS-SG randomized phase 3 trial.

Author

Efficace F, Kicinski M, Coens C, Suciu S, van der Velden WJFM, Noppeney R, Chantepie S, Griskevicius L, Neubauer A, Audisio E, Luppi M, Fuhrmann S, Foà R, Crysandt M, Gaidano G, Vrhovac R, Venditti A, Posthuma EFM, Candoni A, Baron F, Legrand O, Mengarelli A, Fazi P, Vignetti M, Giraut A, Wijermans PW, Huls G, and Lübbert M

Subjects
Humans, Aged, Male, Female, Middle Aged, Aged, 80 and over, Hematopoietic Stem Cell Transplantation, Azacitidine therapeutic use, Surveys and Questionnaires, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Quality of Life, Leukemia, Myeloid, Acute drug therapy, Decitabine therapeutic use, Decitabine administration & dosage, Antimetabolites, Antineoplastic therapeutic use
Abstract

Abstract: We hypothesized that fit older patients with acute myeloid leukemia (AML) treated with decitabine (DEC) would report better health-related quality of life (HRQoL) outcomes than those receiving intensive chemotherapy (IC). We conducted a phase 3 randomized trial to compare DEC (10-day schedule) with IC (3+7) in older fit patients with AML. HRQoL was a secondary end point, and it was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) in conjunction with its elderly module (EORTC QLQ-ELD14). The following scales were a priori selected for defining the primary end point: physical and role functioning, fatigue, pain, and burden of illness. HRQoL was assessed at baseline, at regeneration from cycle 2, and at 6 and 12 months after randomization, and also before allogeneic hematopoietic stem cell transplantation (allo-HSCT) and 100 days after transplantation. Overall, 606 patients underwent randomization. At 2 months, the risk of HRQoL deterioration was lower in the DEC arm than in the 3+7 arm; 76% (95% confidence interval [CI], 69-82) vs 88% (95% CI, 82-93); odds ratio, 0.43 (95% CI, 0.24-0.76; P = .003). No statistically significant HRQoL differences were observed between treatment arms at the long-term evaluation combining assessments at 6 and 12 months. HRQoL deteriorations between baseline and after allo-HSCT were observed in both arms. However, these deteriorations were not clinically meaningful in patients randomized to DEC, whereas this was the case for those in the 3+7 arm, in 4 of 5 primary HRQoL scales. Our HRQoL findings suggest that lower-intensity treatment with DEC may be preferable to current standard IC (3+7) in fit older patients with AML. This trial was registered at www.clinicaltrials.gov as #NCT02172872., (© 2024 American Society of Hematology. Published by Elsevier Inc. All rights are reserved, including those for text and data mining, AI training, and similar technologies.)

Published
2024
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49. Post-transplant cyclophosphamide, calcineurin inhibitor, and mycophenolate mofetil compared to anti-thymocyte globulin, calcineurin inhibitor, and methotrexate combinations as graft-versus-host disease prophylaxis post allogeneic stem cell transplantation from sibling and unrelated donors in patients with acute myeloid leukemia: a study on behalf of the Acute Leukemia Working Party of the European Society for Blood and Marrow Transplantation.

Author

Nagler A, Labopin M, Swoboda R, Schroeder T, Hamladji RM, Griskevicius L, Salmenniemi U, Rambaldi A, Mielke S, Kulagin A, Passweg J, Luft T, Gedde-Dahl T, Forcade E, Helbig G, Stelljes M, Castilla-Llorente C, Spyridonidis A, Brissot E, Ciceri F, and Mohty M

Subjects
Humans, Male, Female, Middle Aged, Adult, Adolescent, Aged, Hematopoietic Stem Cell Transplantation methods, Hematopoietic Stem Cell Transplantation adverse effects, Young Adult, Allografts, Transplantation, Homologous methods, Immunosuppressive Agents therapeutic use, Graft vs Host Disease prevention & control, Graft vs Host Disease etiology, Antilymphocyte Serum therapeutic use, Mycophenolic Acid therapeutic use, Leukemia, Myeloid, Acute therapy, Cyclophosphamide therapeutic use, Calcineurin Inhibitors therapeutic use, Unrelated Donors, Methotrexate therapeutic use, Siblings
Abstract

Post-transplant cyclophosphamide plus calcineurin inhibitor (CNI)(tacrolimus or cyclosporine A) plus mycophenolate mofetil (PTCy/TAC or CSA/MMF) and anti-thymocyte globulin plus CNI (tacrolimus or cyclosporine A) plus methotrexate (ATG/TAC or CSA/MTX) are common graft-versus-host disease (GVHD) prophylaxis regimens. We compared the two regimens in patients with acute myeloid leukemia (AML) undergoing allogeneic transplantation from matched siblings or unrelated donors. 402 received PTCy/TAC or CSA/MMF and 5648 received ATG/TAC or CSA/MTX. Patients in the PTCy-based group were younger (48.7 vs. 51.5 years, p = 0.024) and there was a higher frequency of patient cytomegalovirus seropositivity and female donor to male patient combination in this group (77.8% vs. 71.8%, p = 0.009 and 18.4% vs. 14.4%, p = 0.029, respectively). More patients in the PTCy-based group received reduced-intensity conditioning (51.5% vs. 41%, p < 0.0001). No differences were observed in the incidence of acute GVHD grade II-IV and III-IV (21.2% vs. 20.4%, p = 0.92 and 8.1% vs. 6%, p = 0.1) or 2-year total and extensive chronic GVHD (33.7% vs. 30%, p = 0.09 and 10.7% vs. 11.2%, p = 0.81) between the groups. In the multivariate analysis, all transplant outcomes did not differ between the groups. PTCy/CNI/MMF and ATG/CNI/MTX are alternative regimens for GVHD prophylaxis in AML patients., (© 2024. The Author(s), under exclusive licence to Springer Nature Limited.)

Published
2024
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50. Increase in peg-asparaginase clearance as a predictor for inactivation in patients with acute lymphoblastic leukemia.

Author

Dam M, Centanni M, Friberg LE, Centanni D, Karlsson MO, Stensig Lynggaard L, Johannsdottir IM, Wik HS, Malmros J, Vaitkeviciene GE, Griskevicius L, Hallböök H, Jónsson ÓG, Overgaard U, Schmiegelow K, Hansen SN, Heyman M, and Albertsen BK

Subjects
Humans, Asparaginase, Polyethylene Glycols, Precursor Cell Lymphoblastic Leukemia-Lymphoma drug therapy, Hypersensitivity drug therapy, Antineoplastic Agents therapeutic use
Abstract

Asparaginase is an essential component of acute lymphoblastic leukemia (ALL) therapy, yet its associated toxicities often lead to treatment discontinuation, increasing the risk of relapse. Hypersensitivity reactions include clinical allergies, silent inactivation, or allergy-like responses. We hypothesized that even moderate increases in asparaginase clearance are related to later inactivation. We therefore explored mandatory monitoring of asparaginase enzyme activity (AEA) in patients with ALL aged 1-45 years treated according to the ALLTogether pilot protocol in the Nordic and Baltic countries to relate mean AEA to inactivation, to build a pharmacokinetic model to better characterize the pharmacokinetics of peg-asparaginase and assess whether an increased clearance relates to subsequent inactivation. The study analyzed 1631 real-time AEA samples from 253 patients, identifying inactivation in 18.2% of the patients. This inactivation presented as mild allergy (28.3%), severe allergy (50.0%), or silent inactivation (21.7%). A pharmacokinetic transit compartment model was used to describe AEA-time profiles, revealing that 93% of patients with inactivation exhibited prior increased clearance, whereas 86% of patients without hypersensitivity maintained stable clearance throughout asparaginase treatment. These findings enable prediction of inactivation and options for either dose increments or a shift to alternative asparaginase formulations to optimize ALL treatment strategies., (© 2024. The Author(s).)

Published
2024
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