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1. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial

Author

Hallek, M, Fischer, K, Fingerle-Rowson, G, Fink, AM, Busch, R, Mayer, J, Hensel, M, Hopfinger, G, Hess, G, von Grünhagen, U, Bergmann, M, Catalano, J, Zinzani, PL, Caligaris-Cappio, F, Seymour, JF, Berrebi, A, Jäger, U, Cazin, B, Trneny, M, Westermann, A, Wendtner, CM, Eichhorst, BF, Staib, P, Bühler, A, Winkler, D, Zenz, T, Böttcher, S, Ritgen, M, Mendila, M, Kneba, M, Döhner, H, and Stilgenbauer, S

Published
2010
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11. Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis

Author

Eichhorst, Barbara F, Fischer, Kirsten, Fink, Anna Maria, Elter, Thomas, Wendtner, Clemens M, Goede, Valentin, Bergmann, Manuela, Stilgenbauer, Stephan, Hopfinger, Georg, Ritgen, Matthias, Bahlo, Jasmin, Busch, Raymonde, Hallek, Michael, Oduncu, F, Dreyling, M, Forstpointner, R, Schneller, F, Bogner, C, Peschel, C, Ringshausen, I, Götze, K, Goebeler, Me, Rückle, Lanz, Ritgen, M, Schawitzke, A, Heydrich, B, Kern, K, Böttcher, S, Irmer, S, Strack, U, Borries, V, Klima, Km, Scholz, C, Herold, M, Härtwig, K, Dürig, J, Dührsen, U, Müller Beissenhirtz, H, Noppeney, R, Schüttrumpf, S, Hohloch, K, Binder, C, Hasenkamp, J, Trümper, L, Bäsecke, J, Rieger, M, Witzens Harig, M, Friedrichs, B, Rieger, K, Uharek, L, Kubuschok, B, Murawski, N, Held, G, Zwick, C, Pfreundschuh, M, Fingerle Rowson, G, Reiser, M, Elter, T, Eichhorst, B, Pallasch, C, Hallek, M, Borchmann, P, Hacker, U, Schinkel, S, Wieker, K, Sökler, M, Wolf, Hh, Eucker, J, Staib, P, Schlegel, F, Kropff, M, Kahl, C, Hess, G, Beck, J, Wölfel, T, Bokemeyer, C, Schilling, G, Dierlamm, J, Schüler, F, Busemann, C, Dölken, G, Trendelenburg, Tk, Bühler, A, Stilgenbauer, S, Viardot, A, Greiner, J, Zenz, T, Gaidzik, V, Langer, C, Döhner, H, Werner, I, Dienst, A, Habersang, K, Härtel, N, Leitner, A, Kehrer, G, Middeke, H, Heinisch, K, Adorf, D, Ismer, B, Hering Schubert, C, Jäckle, J, Aulmann, C, Söllner, S, Majunke, P, Fuss, H, Käfer, G, Potenberg, J, Dietrich, G, Hartung, E, Pronath, A, Riedhammer, Fj, Zehrfeld, T, Prümmer, O, Gatter, J, Meier, A, Wattad, M, Heit, W, Sauer, I, Hilgers, K, Geissler, M, Bauer, J, Stein, W, Voigtmann, R, Natt, F, Nickelsen, M, Zeis, M, Schmitz, N, Lange, E, Stoltefuss, A, Schubert, J, Dürk, Ha, Kloke, O, Fauser, A, Roemer, E, Kraut, L, Musch, E, Kohl, S, Link, H, Kirsch, Jf, Schatz, M, Mezger, J, Kempf, B, Heil, G, Derigs, Hg, Roll, C, Kettner, E, Dübbers, Hw, Lutz, L, Hentrich, M, Hoffmann, U, Ibe, M, Falge, C, Schäfer Eckart, K, Rothmann, F, Raghavachar, A, Beckmann, K, Behringer, D, Stauder, H, Hempfling, C, Matzdorff, A, Hähling, D, Kaesberger, Kj, Mück, R, Waladkhani, Ar, Clemens, M, Kraft, J, Ehlert, T, N. N., Schloen, A, Sandritter, B, Scholz, Diekmann, C, Pflüger, Kh, Hausner, G, Fetscher, S, Aulitzky, W, Brugger, W, Frickhofen, N, Fuhr, Lange, C, Lambertz, H, Schulz, L, Schmier, M, Bentz, M, Tauchmann, Gm, Schmidt, M, Meiler, J, Sandmann, M, Kürschner, D, Maier Bay, B, Lindemann, W, Diers, J, Riemeier Sievers, C, Daun, M, Mergenthaler, Hg, Hiller, S, Schirmer, V, Kirchner, H, Langer, W, Günther, B, Gassmann, W, Franke, K, Burghardt, F, Abele, U, Celikel Becker, D, von Weikersthal LF, Brög, G, Hauch, U, Heinrich, B, Brudler, O, Häcker, B, Eckart, Mj, Bolouri, H, Göttler, B, Kindler, M, Zuchold, K, Strohbach, F, Plingen, Ml, Seibt Jung, H, Kirsch, A, Herrenberger, J, Doering, G, von Grünhagen, U, Franke, H, Weniger, J, Kerzel, W, Schmalfeld, M, Rohrberg, R, Hurtz, Hj, Gehbauer, G, Hahnfeld, S, Vehling Kaiser, U, Abenhardt, W, Bosse, D, Böning, L, Schmidt, B, Schick, Hd, Jacobs, G, Stauch, M, Hoffmann, R, Müller, S, Hahn, M, Freier, W, Dietzfelbinger, H, Rassmann, I, Söling, U, Siehl, S, Rudolph, R, Weinert, R, Sauer, A, Meyer, B, Eschenburg, H, Schadeck Gressel, C, Grabenhorst, U, Perker, M, Otremba, B, Reschke, D, Hinrichs, Hf, Zirpel, I, Höring, E, Respondek, M, Köppler, H, Heymanns, J, Weide, R, Hünermund, K, Thiel, C, Reiber, T, Spohn, C, Springer, G, Fiechtner, H, Hübner, A, Kurschel, E, Weiss, J, Schlag, R, Schäfer, E, Hartwich, G, Schmitz, S, Steinmetz, T, Kim, Ts, Lerchenmüller, C, Wehmeyer, J, Laubenstein, Hp, Rendenbach, B, Lebahn, H, Kröning, H, Uhle, R, Balló, H, Gaede, B, Zumbrink, S, Eckert, R, Kamp, T, Reimann, B, Burkhard, O, Mittermüller, J, Hansen, R, Hitz, H, Schliesser, G, Schmitt, Hr, Forstbauer, H, Grundeis, M, Schulze, M, Baldus, M, Lakner, V, Haen, M, Müller, C, Dörfel, S, Göhler, T, Welslau, M, Achtzehn, V, Culmann, H, Gerhardt, S, Ulshöfer, T, Koschuth, A, Schmidt, P, Müller, L, Schneider, M, Koniczek, K, Porowski, P, Glados, M, Knoblich, J, Ben Yehuda, D, Jäger, U, Gaiger, A, Schwarzmeier, J, Nösslinger, T, Smith, M, Patton, N, Gibbons, S, Bouabdallah, R, Gandhi, M, Marlton, P, Mills, T, Angelucci, E, Sorano, Gg, Casula, P, Berneman, Z, Kohser, P, Hudcova Burgetova, A, Machová, R, Papajik, T, Kubová, Z, Fineman, R, Mayer, J, Doubek, M, Brychtova, Y, Ciceri, F, Caligaris Cappio, F, Crocchiolo, R, Dauriac, C, Bernard, M, Escoffre Barbe, M, Lamy, T, Zikesova, E, Karban, J, Salkova, J, Trnený, M, Pytlik, R, Tiley, C, Forsyth, C, Vokurka, S, Koza, V, Van Hoof, A, Selleslag, D, Sebban, C, Baker, B, Belada, D, Jebavy, L, Smolej, L, Pavel, Z, Di Ianni, M, Castaigne, S, Del Poeta, G, Amadori, S, Catalano, J, Ganju, V, Hertzberg, M, Laurenti, L, Dalseg, Am, Bron, D, Morton, J, Durrant, S, Casado, Lf, Theunissen, K, Atias, D, Berkhan, L, Seymour, J, Wolf, M, Bosly, A, Osma Cordoba MM, Portois, C, Jaubert, J, Ferrant, A, Lambert, C, Maerevoet, E, Van den Neste, E, Gadeberg, O, Carney, B, Cannell, P, Eghbali, H, Legouffe, E, Bordessoule, D, Chaury, M, Moreau, S, Pierri, I, Gobbi, M, Berrebi, A, Lishner, M, Yerushazim, R, Yermiaku, T, Kosolov, V, Ambrosetti, Achille, Andreoli, Al, Huguet, F, Laurent, G, Orsucci, L, Forconi, F, Musuraca, G, Zinzani, Pl, Loscertales, J, Mcquillan, A, Cordingley, F, Leahy, M, Cazin, B, Taylor, Mulligan, S, Herbrecht, Cull, G, Seldon, M, Rowlings, P, Ludwig, H, Zojer, N, Solal Céligny, P, Pomponi, F, Savdkova, L, Kozák, T, Christiansen, I, Pérez, I, Campbell, P, Canales Albendea, M, De Paz, R, Arthur, C, Gisselbrecht, C., Eichhorst B.F., Fischer K., Fink A.M., Elter T., Wendtner C.M., Goede V., Bergmann M., Stilgenbauer S., Hopfinger G., Ritgen M., Bahlo J., Busch R., Hallek M., and Zinzani P.L.

Subjects
Male, medicine.medical_specialty, Cyclophosphamide, Chronic lymphocytic leukemia, Immunology, Medizin, Antineoplastic Combined Chemotherapy Protocols, Blood Cell Count, Disease Progression, Disease-Free Survival, Female, Follow-Up Studies, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Middle Aged, Prognosis, Recurrence, Remission Induction, Tomography, X-Ray Computed, Physical examination, Biochemistry, Chemoimmunotherapy, medicine, Chronic, Tomography, Leukemia, medicine.diagnostic_test, business.industry, B-Cell, Cancer, Cell Biology, Hematology, medicine.disease, Lymphocytic, imaging techniques, X-Ray Computed, Fludarabine, Surgery, chronic lymphocytic leukemia, Radiology, business, Progressive disease, medicine.drug
Abstract

The clinical value of imaging is well established for the follow-up of many lymphoid malignancies but not for chronic lymphocytic leukemia (CLL). A meta-analysis was performed with the dataset of 3 German CLL Study Group phase 3 trials (CLL4, CLL5, and CLL8) that included 1372 patients receiving first-line therapy for CLL. Response as well as progression during follow-up was reassessed according to the National Cancer Institute Working Group1996 criteria. A total of 481 events were counted as progressive disease during treatment or follow-up. Of these, 372 progressions (77%) were detected by clinical symptoms or blood counts. Computed tomography (CT) scans or ultrasound were relevant in 44 and 29 cases (9% and 6%), respectively. The decision for relapse treatment was determined by CT scan or ultrasound results in only 2 of 176 patients (1%). CT scan results had an impact on the prognosis of patients in complete remission only after the administration of conventional chemotherapy but not after chemoimmunotherapy. In conclusion, physical examination and blood count remain the methods of choice for staging and clinical follow-up of patients with CLL as recommended by the International Workshop on Chronic Lymphocytic Leukemia 2008 guidelines. These trials are registered at http://www.isrctn.org as ISRCTN 75653261 and ISRCTN 36294212 and at http://www.clinicaltrials.gov as NCT00281918.

Published
2011

12. MUTATION ANALYSIS BY TARGETED NEXT GENERATION SEQUENCING IN ULTRA HIGH RISK CLL PATIENTS TREATED WITHIN THE CLL2O STUDY

Author

Estenfelder, S., Tausch, E., Huber, H., Bloehdorn, J., Cymbalista, F., Leblond, V., Delmer, A., Ibach, S., Choquet, S., Dartigeas, C., Cazin, B., Tournilhac, O., Pegourie, B., Seiler, T., Soekler, M., Zirlik, K., Alt, J., Schetelig, J., Hallek, M., Dreger, P., Doehner, H., Stilgenbauer, S., Estenfelder, S., Tausch, E., Huber, H., Bloehdorn, J., Cymbalista, F., Leblond, V., Delmer, A., Ibach, S., Choquet, S., Dartigeas, C., Cazin, B., Tournilhac, O., Pegourie, B., Seiler, T., Soekler, M., Zirlik, K., Alt, J., Schetelig, J., Hallek, M., Dreger, P., Doehner, H., and Stilgenbauer, S.

Published
2016

13. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial

Author

Hallek M, Fischer K, Fingerle Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grünhagen U, Bergmann M, Catalano J, Caligaris Cappio F, Seymour JF, Berrebi A, Jäger U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Bühler A, Winkler D, Zenz T, Böttcher S, Ritgen M, Mendila M, Kneba M, Döhner H, Stilgenbauer S, International Group of Investigators, German Chronic Lymphocytic Leukaemia Study Group, ZINZANI, PIER LUIGI, Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grünhagen U, Bergmann M, Catalano J, Zinzani PL, Caligaris-Cappio F, Seymour JF, Berrebi A, Jäger U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Bühler A, Winkler D, Zenz T, Böttcher S, Ritgen M, Mendila M, Kneba M, Döhner H, Stilgenbauer S, International Group of Investigator, and German Chronic Lymphocytic Leukaemia Study Group.

Subjects
Adult, Male, medicine.medical_specialty, Neutropenia, FCR Regimen, Kaplan-Meier Estimate, Ofatumumab, Severity of Illness Index, Gastroenterology, Disease-Free Survival, Drug Administration Schedule, Antibodies, Monoclonal, Murine-Derived, chemistry.chemical_compound, Chemoimmunotherapy, Obinutuzumab, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Humans, Immunologic Factors, Medicine, Cyclophosphamide, Aged, Aged, 80 and over, business.industry, Incidence, Antibodies, Monoclonal, Leukopenia, General Medicine, Middle Aged, Leukemia, Lymphocytic, Chronic, B-Cell, Surgery, Fludarabine, Treatment Outcome, chemistry, Disease Progression, Female, Rituximab, Refractory Chronic Lymphocytic Leukemia, business, Vidarabine, Untreated Chronic Lymphocytic Leukemia, medicine.drug
Abstract

On the basis of promising results that were reported in several phase 2 trials, we investigated whether the addition of the monoclonal antibody rituximab to first-line chemotherapy with fludarabine and cyclophosphamide would improve the outcome of patients with chronic lymphocytic leukaemia.Treatment-naive, physically fit patients (aged 30-81 years) with CD20-positive chronic lymphocytic leukaemia were randomly assigned in a one-to-one ratio to receive six courses of intravenous fludarabine (25 mg/m(2) per day) and cyclophosphamide (250 mg/m(2) per day) for the first 3 days of each 28-day treatment course with or without rituximab (375 mg/m(2) on day 0 of first course, and 500 mg/m(2) on day 1 of second to sixth courses) in 190 centres in 11 countries. Investigators and patients were not masked to the computer-generated treatment assignment. The primary endpoint was progression-free survival (PFS). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00281918.408 patients were assigned to fludarabine, cyclophosphamide, and rituximab (chemoimmunotherapy group) and 409 to fludarabine and cyclophosphamide (chemotherapy group); all patients were analysed. At 3 years after randomisation, 65% of patients in the chemoimmunotherapy group were free of progression compared with 45% in the chemotherapy group (hazard ratio 0·56 [95% CI 0·46-0·69], p0·0001); 87% were alive versus 83%, respectively (0·67 [0·48-0·92]; p=0·01). Chemoimmunotherapy was more frequently associated with grade 3 and 4 neutropenia (136 [34%] of 404 vs 83 [21%] of 396; p0·0001) and leucocytopenia (97 [24%] vs 48 [12%]; p0·0001). Other side-effects, including severe infections, were not increased. There were eight (2%) treatment-related deaths in the chemoimmunotherapy group compared with ten (3%) in the chemotherapy group.Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab improves progression-free survival and overall survival in patients with chronic lymphocytic leukaemia. Moreover, the results suggest that the choice of a specific first-line treatment changes the natural course of chronic lymphocytic leukaemia.F Hoffmann-La Roche.

Published
2010

15. 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

Deshmukh C.D., Offner F., Van Den Neste E.W., Wu K.L., Van Hoof A., Maiolino A., Pinczowski H., Zanichelli M.A., Pereira J., Larratt L., Spaner D., Howson-Jan K., Chen C.I., Cantin G., Fernandez L.A., Fraser G., Mayer J., Trneny M., Jebavy L., Bordessoule D., Lamy T., Milpied N., Truchan-Graczyk M., Eghbali H., Karsenti J.-M., Celigny P.S., Mans L., Cazin B., Gyan E., Lepretre S., Bergmann L., Tsionos K., Lokeshwar N.M., Agarwal M.B., Ross C.R., Narayanan G., Raina V., Bondarde S.A., Shah B.A., Bairey O., Tikva P., Shvidel L., Ambrosetti A., Rossi P.G.B., Angelucci E., Carella A.M., Massaia M., Zinzani P.L., Caligaris-Cappio F., Foa R., Gaidano G., della Carita A.O.M., Leone G., Santoro A., Griskevicius L., Jurgutis R., Baker B.W., Hawkins T., Corbett G.M., Ganly P., D'Souza A.B., Deptala A., Holowiecki J., Kloczko J., Skotnicki A., Zdziarska B., Kyrcz-Krzemien S., Dmoszynska A., Moreira I., Pereira A.P., Colita A., Moicean A.D., Vasilica M., Danaila C., Gheorghita E., Pavlov V.V., Rossiev V.A., Konstantinova T., Samoilova O.S., Novgorod N., Shelekhova T., Zaritsky A.Y., Abdulkadyrov K.M., Zyuzgin I.S., Pristupa A.S., Loscertales J., Vidal J.B., de Mallorca P., Gonzalez M., Ortuno F., Giraldo P., Nathwani A., Agrawal S.G., Rule S., Dearden C.E., Bloor A.J., Haynes A., Singer C., Boclek R.G., Bosserman L.D., Chan D., Davidson S.J., Dichmann R.A., Farber C., Hart L., Hermann R., Hu E., Janakiraman N., Jonas W., Liem K.D., Mcintyre R.E., O'Brien S., Patel G., Rado T., Schilder R., Smith S.E., Stock W., Turturro F., Venugopal P., Anderson T.C., Berry W., Boyd T.E., Byrd J., Cooper M., Flinn I., Gersh R., Gordon D., Guzley G.J., Wilks S.T., Klein A., Krauss J.C., Lister J., Mandell L., Molina A., Cooper B., Pendergrass K.B., Reeder C., Savin M.A., Spitzer G., Tuscano J.M., vanDeventer H., Eradat H.A., Masood A., Mena R., Awan F.T., Hillmen P., Hellmann A., Robak T., Hughes S.G., Trone D., Shannon M., Flinn I.W., Byrd J.C., Riveros D., Pavlovsky S., Iastrebner C.M., Carney D.A., Deveridge S., Durrant S., Hahn U.H., Hertzberg M., Leahy M.F., Ma D., Marlton P., Mulligan S., Opat S.S., Tiley C., Wickham N.W., Cannell P., Gatalano J., Catalano J., Cull G., To L.B., Hopfinger G., Jager U., Linkesch W., Petzer A., Schwarzmeier J., Steurer M., Greil R., Bememan Z., Bosly A., Bron D., Janssens A., Deshmukh C.D., Offner F., Van Den Neste E.W., Wu K.L., Van Hoof A., Maiolino A., Pinczowski H., Zanichelli M.A., Pereira J., Larratt L., Spaner D., Howson-Jan K., Chen C.I., Cantin G., Fernandez L.A., Fraser G., Mayer J., Trneny M., Jebavy L., Bordessoule D., Lamy T., Milpied N., Truchan-Graczyk M., Eghbali H., Karsenti J.-M., Celigny P.S., Mans L., Cazin B., Gyan E., Lepretre S., Bergmann L., Tsionos K., Lokeshwar N.M., Agarwal M.B., Ross C.R., Narayanan G., Raina V., Bondarde S.A., Shah B.A., Bairey O., Tikva P., Shvidel L., Ambrosetti A., Rossi P.G.B., Angelucci E., Carella A.M., Massaia M., Zinzani P.L., Caligaris-Cappio F., Foa R., Gaidano G., della Carita A.O.M., Leone G., Santoro A., Griskevicius L., Jurgutis R., Baker B.W., Hawkins T., Corbett G.M., Ganly P., D'Souza A.B., Deptala A., Holowiecki J., Kloczko J., Skotnicki A., Zdziarska B., Kyrcz-Krzemien S., Dmoszynska A., Moreira I., Pereira A.P., Colita A., Moicean A.D., Vasilica M., Danaila C., Gheorghita E., Pavlov V.V., Rossiev V.A., Konstantinova T., Samoilova O.S., Novgorod N., Shelekhova T., Zaritsky A.Y., Abdulkadyrov K.M., Zyuzgin I.S., Pristupa A.S., Loscertales J., Vidal J.B., de Mallorca P., Gonzalez M., Ortuno F., Giraldo P., Nathwani A., Agrawal S.G., Rule S., Dearden C.E., Bloor A.J., Haynes A., Singer C., Boclek R.G., Bosserman L.D., Chan D., Davidson S.J., Dichmann R.A., Farber C., Hart L., Hermann R., Hu E., Janakiraman N., Jonas W., Liem K.D., Mcintyre R.E., O'Brien S., Patel G., Rado T., Schilder R., Smith S.E., Stock W., Turturro F., Venugopal P., Anderson T.C., Berry W., Boyd T.E., Byrd J., Cooper M., Flinn I., Gersh R., Gordon D., Guzley G.J., Wilks S.T., Klein A., Krauss J.C., Lister J., Mandell L., Molina A., Cooper B., Pendergrass K.B., Reeder C., Savin M.A., Spitzer G., Tuscano J.M., vanDeventer H., Eradat H.A., Masood A., Mena R., Awan F.T., Hillmen P., Hellmann A., Robak T., Hughes S.G., Trone D., Shannon M., Flinn I.W., Byrd J.C., Riveros D., Pavlovsky S., Iastrebner C.M., Carney D.A., Deveridge S., Durrant S., Hahn U.H., Hertzberg M., Leahy M.F., Ma D., Marlton P., Mulligan S., Opat S.S., Tiley C., Wickham N.W., Cannell P., Gatalano J., Catalano J., Cull G., To L.B., Hopfinger G., Jager U., Linkesch W., Petzer A., Schwarzmeier J., Steurer M., Greil R., Bememan Z., Bosly A., Bron D., and Janssens A.

Abstract

Summary: 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.Copyright © 2014 John Wiley & Sons Ltd.

Published
2015

17. Early versus deferred treatment with combined fludarabine, cyclophosphamide and rituximab (FCR) improves event-free survival in patients with high-risk Binet stage A chronic lymphocytic leukemia (CLL)

Author

Mueller, C., Cymbalista, F., Schweighofer, C., Busch, R., Porcher, R., Langerbeins, P., Cazin, B., Fink, A. -M., Dreyfus, B., Ibach, S., Lepretre, S., Fischer, K., Vehling-Kaiser, U., Eichhorst, B., Bergmann, M. A., Wendtner, C. -M., Stilgenbauer, S., Doehner, H., Leblond, V., Hallek, M., Levy, V., Mueller, C., Cymbalista, F., Schweighofer, C., Busch, R., Porcher, R., Langerbeins, P., Cazin, B., Fink, A. -M., Dreyfus, B., Ibach, S., Lepretre, S., Fischer, K., Vehling-Kaiser, U., Eichhorst, B., Bergmann, M. A., Wendtner, C. -M., Stilgenbauer, S., Doehner, H., Leblond, V., Hallek, M., and Levy, V.

Published
2014

19. Cost Effectiveness Impact Of Oral Fludarabine In Chronic Lymphocytic Leukemia. The French Experience

Author

Leporrier, M., Cazin, B., Maloum, K., Lenne, X., Theis, D., D'Alche-Gautier, M.C., Rufat, P., Prunieras, F., Compagne, C., Dervaux, B., Legrand, Annette, UMR CNRS 8179, and Université de Lille, Sciences et Technologies-Centre National de la Recherche Scientifique (CNRS)

Subjects
[SDV.CAN] Life Sciences [q-bio]/Cancer, [SDV.CAN]Life Sciences [q-bio]/Cancer, [SHS.ECO]Humanities and Social Sciences/Economics and Finance, [SHS.ECO] Humanities and Social Sciences/Economics and Finance
Published
2005

20. Guide pratique de l'agent préleveur chargé de la police des milieux aquatiques

Author

Le Pimpec, P., Liénard, A., Bonnard, R., Lafont, M., Cazin, B., Bossard, P., Hubert, B., Bray, M., and Irstea Publications, Migration

Subjects
[SDE] Environmental Sciences
Abstract

This guide was designed to be used by agents in charge of water policy by controlling the water and fishing in freshwater bodies and who have the knowledge and experience (know-how) to detect water pollution and to draw-up offence reports if necessary. It describes the legislative and regulatory framework regarding their work, procedures to follow, as well as the sampling, the first tests and the investigations to be performed while on site. The chapters dealing with the chemical and hydro ecological foundations allow an appropriate comprehension of the tests results and analyses done in laboratory on samples of water, sediments and living organisms. A variety of information on the reference values of the physico-chemical parameters in a natural setting, the toxicity references concerning aquatic organisms, the parameters and the normal parameters and values of typical pollution cases, etc ... are all given in tables. One final chapter is dedicated to the principal forms of wastewater treatment processes and to specific indicators, to allow one to recognise a poorly functioning treatment plant, even before performing a single analysis. Besides those for whom the book is intended, it can offer useful information to those interested in fresh waters, their biological functioning and in the pollution which may affect them., Ce guide a été conçu à l'usage des agents chargés des missions de police de l'eau et de la pêche en eau douce et qui sont habilités à constater une pollution des eaux et à dresser procès verbal. Il décrit donc le cadre législatif et réglementaire dans lequel s'inscrit leur mission, les procédures à respecter, ainsi que les prélèvements et les premières analyses et constatations à effectuer sur le terrain. Les chapitres traitant des notions de chimie et d'hydroécologie permettent une bonne compréhension de l'interprétation des résultats de ces analyses et de celles menées en laboratoire sur les prélèvements d'eau, de sédiments et d'organismes vivants. De nombreuses informations sur les valeurs guides des composantes physico-chimiques dans le milieu naturel, les références de toxicité vis à vis des organismes aquatiques, les paramètres et valeurs caractéristiques de cas concrets de pollution, etc_, sont données sous forme de tableaux. Un dernier chapitre est consacré aux principales filières de traitement d'eaux usées et à quelques indices permettant de reconnaître un mauvais fonctionnement de station d'épuration avant toute analyse. Outre les personnes à qui il est destiné, cet ouvrage peut apporter des informations utiles à tous ceux qui s'intéressent aux eaux douces, à leur fonctionnement biologique et aux pollutions qui peuvent les affecter.

Published
2002

21. Acadesine for Patients With Relapsed/refractory Chronic Lymphocytic Leukemia: a Multicentre Phase I/ii Study

Author

UCL - Cliniques universitaires Saint-Luc, UCL - SSS/DDUV - Institut de Duve, Van Den Neste, Eric, Janssens, A., Gonzalez-Barca, E., Cazin, B., Terol, M. J., Levy, V., Perez de Oteyza, J., Saunders, A., De Elias, M., Campas, C., 15th Annual Meeting of the European-Hematology-Association, UCL - Cliniques universitaires Saint-Luc, UCL - SSS/DDUV - Institut de Duve, Van Den Neste, Eric, Janssens, A., Gonzalez-Barca, E., Cazin, B., Terol, M. J., Levy, V., Perez de Oteyza, J., Saunders, A., De Elias, M., Campas, C., and 15th Annual Meeting of the European-Hematology-Association

Published
2010

22. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial

Author

Hallek, M., Fischer, K., Fingerle-Rowson, G., Fink, A. M., Busch, R., Mayer, J., Hensel, M., Hopfinger, G., Hess, G., von Gruenhagen, U., Bergmann, M., Catalano, J., Zinzani, P. L., Caligaris-Cappio, F., Seymour, J. F., Berrebi, A., Jaeger, U., Cazin, B., Trneny, M., Westermann, A., Wendtner, C. M., Eichhorst, B. F., Staib, P., Buehler, A., Winkler, D., Zenz, T., Boettcher, S., Ritgen, M., Mendila, M., Kneba, M., Doehner, H., Stilgenbauer, S., Hallek, M., Fischer, K., Fingerle-Rowson, G., Fink, A. M., Busch, R., Mayer, J., Hensel, M., Hopfinger, G., Hess, G., von Gruenhagen, U., Bergmann, M., Catalano, J., Zinzani, P. L., Caligaris-Cappio, F., Seymour, J. F., Berrebi, A., Jaeger, U., Cazin, B., Trneny, M., Westermann, A., Wendtner, C. M., Eichhorst, B. F., Staib, P., Buehler, A., Winkler, D., Zenz, T., Boettcher, S., Ritgen, M., Mendila, M., Kneba, M., Doehner, H., and Stilgenbauer, S.

Abstract

Background On the basis of promising results that were reported in several phase 2 trials, we investigated whether the addition of the monoclonal antibody rituximab to first-line chemotherapy with fludarabine and cyclophosphamide would improve the outcome of patients with chronic lymphocytic leukaemia. Methods Treatment-naive, physically fit patients (aged 30-81 years) with CD20-positive chronic lymphocytic leukaemia were randomly assigned in a one-to-one ratio to receive six courses of intravenous fludarabine (25 mg/m(2) per day) and cyclophosphamide (250 mg/m(2) per day) for the first 3 days of each 28-day treatment course with or without rituximab (375 mg/m(2) on day 0 of first course, and 500 mg/m(2) on day 1 of second to sixth courses) in 190 centres in 11 countries. Investigators and patients were not masked to the computer-generated treatment assignment. The primary endpoint was progression-free survival (PFS). Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00281918. Findings 408 patients were assigned to fludarabine, cyclophosphamide, and rituximab (chemoimmunotherapy group) and 409 to fludarabine and cyclophosphamide (chemotherapy group); all patients were analysed. At 3 years after randomisation, 65% of patients in the chemoimmunotherapy group were free of progression compared with 45% in the chemotherapy group (hazard ratio 0.56 [95% CI 0.46-0.69], p<0.0001); 87% were alive versus 83%, respectively (0.67 [0.48-0.92]; p=0.01). Chemoimmunotherapy was more frequently associated with grade 3 and 4 neutropenia (136 [34%] of 404 vs 83 [21%] of 396; p<0.0001) and leucocytopenia (97 [24%] vs 48 [12%]; p<0.0001). Other side-effects, including severe infections, were not increased. There were eight (2%) treatment-related deaths in the chemoimmunotherapy group compared with ten (3%) in the chemotherapy group. Interpretation Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab improves progression-free

Published
2010

25. Treatment of acute lymphoblastic leukemia in the elderly: An evaluation of interferon alpha given as a single agent after complete remission

Author

UCL - (SLuc) Service d'hématologie, Delannoy, A., Cazin, B., Thomas, X., Bouabdallah, R., Boiron, J.M., Huguet, F., Straetmans, N., Zérazhi, H., Vernant, J.P., Dombret, H., Bilhou-Nabera, C., Charrin, C., Boucheix, C., Sebban, C., Lhéritier, V., Fière, D., UCL - (SLuc) Service d'hématologie, Delannoy, A., Cazin, B., Thomas, X., Bouabdallah, R., Boiron, J.M., Huguet, F., Straetmans, N., Zérazhi, H., Vernant, J.P., Dombret, H., Bilhou-Nabera, C., Charrin, C., Boucheix, C., Sebban, C., Lhéritier, V., and Fière, D.

Abstract

Although interferon (IFN) has been used in elderly patients with acute lymphoblastic leukemia (ALL), the benefits from IFN therapy have not been properly assessed, especially as it was given combined with other cytotoxic drugs, which obscured the role of IFN if any. In 1997, we started a study aimed at improving our previous results in elderly patients with ALL and at assessing the therapeutic role of IFN in this disease. Fifty-eight patients with ALL, aged 55-81 years (median: 64.9 years), were randomly allocated to treatment with vindesine or vincristine during induction. After a first consolidation course, IFN was administered as a single agent for three months together with cranial radiotherapy. Chemotherapy was then resumed with a second consolidation course and maintenance. A complete remission (CR) was obtained in 58% of patients (CI: 45-71%), significantly less than in our previous study which included IFN combined with chemotherapy during maintenance (CR: 85%, CI:70-94%, p = 0.007). Overall survival (median: 289 vs 434 days in the previous study, p = 0.01) and disease-free survival (median: 146 vs 427 days, p = 0.009) were also inferior in the present study. In particular, the pattern of relapses over time suggested that the 3 month IFN treatment phase with no additional chemotherapy might have contributed to the comparatively poor outcome of this cohort. In addition, vindesine given during induction did not prove less neurotoxic than vincristine, did not improve the CR rate, and had no impact on survival. In conclusion, although similar to published studies in elderly patients with ALL, this study is inferior to our previous one. INF, given as a single drug, has a modest role if any in the treatment of older persons with ALL.

Published
2002

26. Incidence de rejets ponctuels et diffus sur les communautés d'invertébrés benthiques d'un cours d'eau du Beaujolais : l'Ardières

Author

Faessel, B., Roger, M.C., Cazin, B., and Irstea Publications, Migration

Subjects
[SDE] Environmental Sciences, ARDIERES, CEMAGREF, BEAUJOLAIS
Abstract

Almost half of the Ardières watershed (a Saône tributary) is occupied by vine culture, which leads to a diffuse pollution of the water stream by runoff waters. The goal of the study is to find out the biological quality of this river, and more specifically to characterize the vine treatments (herbicides, fungicides, insecticides) impact on the benthic populations., Près de la moitié du bassin versant de l'Ardières (affluent de la Saône) est occupée par la culture de la vigne induisant dans le cours d'eau une pollution diffuse par les eaux de ruissellement. L'étude a pour but de déterminer la qualité biologique de cette rivière et plus spécifiquement de caractériser l'impact des traitements viticoles (herbicides, fongicides, insecticides) sur les peuplements benthiques.

Published
1993

29. La réduction des matières en suspension dans l'eau d'alimentation des salles d'incubation en salmoniculture

Author

Cazin, B., Le Pimpec, P., and Irstea Publications, Migration

Subjects
[SDE] Environmental Sciences, CEMAGREF
Abstract

This method, simple to set up, keeps on a filter made of synthetic wadding and of moss almost 70% of the suspended matters in the water. Designed for salmon breeding, it is possible to adapt it to other fish farming operations., Cette méthode simple à mettre en oeuvre permet de retenir sur un filtre composé de ouate synthétique et de mousse près de 70 % des matières en suspension dans l'eau. Etudiée pour la salmoniculture, il est possible de l'adapter aux autres élevages piscicoles.

Published
1991

30. Mise au point d'une 'bouteille à prélèvement'

Author

Rumeau, Axel, Cazin, B., and Irstea Publications, Migration

Subjects
[SDE] Environmental Sciences, CEMAGREF
Abstract

This sampling bottle allows to sample water at different depths in water streams, lakes and ponds. One of the transparent sides of the bottle ensures a good visibility of the plankton amount., Cette bouteille à prélèvement permet un échantillonnage des eaux à différentes profondeurs dans les cours d'eau, les lacs, les étangs. Un des côtés transparent assure une bonne visibilité de la quantité de plancton.

Published
1990

31. Development of a ' sampling bottle '

Author

Rumeau, Axel, Cazin, B., Irstea Publications, Migration, CONSEIL SUPERIEUR DE LA PECHE, Partenaires IRSTEA, Institut national de recherche en sciences et technologies pour l'environnement et l'agriculture (IRSTEA)-Institut national de recherche en sciences et technologies pour l'environnement et l'agriculture (IRSTEA), Qualité des eaux et prévention des pollutions (UR QELY), and Centre national du machinisme agricole, du génie rural, des eaux et forêts (CEMAGREF)

Subjects
[SDE] Environmental Sciences, CEMAGREF, [SDE]Environmental Sciences
Abstract

This sampling bottle allows to sample water at different depths in water streams, lakes and ponds. One of the transparent sides of the bottle ensures a good visibility of the plankton amount., Cette bouteille à prélèvement permet un échantillonnage des eaux à différentes profondeurs dans les cours d'eau, les lacs, les étangs. Un des côtés transparent assure une bonne visibilité de la quantité de plancton.

Published
1990

32. Transplantation in Waldenstrom's macroglobulinemia—the French experience

Author

Tournilhac, O., primary, Leblond, V., additional, Tabrizi, R., additional, Gressin, R., additional, Senecal, D., additional, Milpied, N., additional, Cazin, B., additional, Divine, M., additional, Dreyfus, B., additional, Cahn, J.Y., additional, Pignon, B., additional, Desablens, B., additional, Perrier, J.F., additional, Bay, J.O., additional, and Travade, P., additional

Published
2003
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33. Age-adapted induction treatment of acute lymphoblastic leukemia in the elderly and assessment of maintenance with interferon combined with chemotherapy : A multicentric prospective study in forty patients

Author

UCL - (SLuc) Service d'hématologie, Delannoy, André, Sebban, C., Cony-Makhoul, P, Cazin, B., Cordonnier, C., Bouabdallah, R., Cahn, J.Y., Dreyfus, F, Sadoun, A., Vernant, J.P., Gay, C., Broustet, A., Michaux, Jean-Louis, Fière, D., UCL - (SLuc) Service d'hématologie, Delannoy, André, Sebban, C., Cony-Makhoul, P, Cazin, B., Cordonnier, C., Bouabdallah, R., Cahn, J.Y., Dreyfus, F, Sadoun, A., Vernant, J.P., Gay, C., Broustet, A., Michaux, Jean-Louis, and Fière, D.

Abstract

Acute lymphoblastic leukemia (ALL) in the elderly is characterized by its poor prognosis. Forty patients with ALL, aged 55 years or older, and with good performance status (ECOG <3) were prospectively treated according to an age-adapted regimen: induction therapy was derived from the LALA87 protocol while the feasibility of treatment with interferon combined with chemotherapy was assessed during maintenance. Compared with younger adults treated according to the LALA87 protocol, elderly patients did not present with more adverse prognostic features, except for a lower incidence of T cell ALL (9 vs 31%, P = 0.005). There were even less patients with a high leukocyte count (15 vs 38%, P = 0.003), a characteristic associated with adverse prognosis while the incidence of Philadelphia-positive (Ph-positive) ALL was not significantly increased compared to younger adults (31 vs 20%, P = 0.2). After completion of induction therapy, with or without salvage treatment, 85% (CI: 70-94%) obtained a complete response (CR) while treatment-related mortality during induction was 7.5% (CI: 2-20%). Median overall survival and disease-free survival were 14.3 months and 14 months, respectively, which, although inferior to results achieved in younger adults, compares favorably with available data in the elderly. Treatment with IFN proved feasible in most patients but had to be discontinued in eight patients because of toxicity. Age-adapted treatment improves the prognosis of ALL in the elderly even if, in most cases, a cure cannot be achieved.

Published
1997

34. Treatment of Acute Lymphoblastic Leukemia in the Elderly: An Evaluation of Interferon Alpha Given as a Single Agent After Complete Remission

Author

Delannoy, A., primary, Cazin, B., additional, Thomas, X., additional, Bouabdallah, R., additional, Boiron, J.M., additional, Huguet, F., additional, Straetmans, N., additional, Zérazhi, H., additional, Vernant, J.P., additional, Dombret, H., additional, Bilhou-Nabera, C., additional, Charrin, C., additional, Boucheix, C., additional, Sebban, C., additional, Lhéritier, V., additional, and Fière, D., additional

Published
2002
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40. Effects of point and nonpoint pollution on benthic invertebrate communities in the river Ardieres (Beaujolais)

Author

Faessel, B., Roger, M., and Cazin, B.

Abstract

Pr?s de la moiti? du bassin versant de l'Ardi?res (affluent de la Sa?ne) est occup?e par la culture de la vigne induisant dans le cours d'eau une pollution diffuse par les eaux de ruissellement. L'?tude a pour but de d?terminer la qualit? biologique de cette rivi?re et plus sp?cifiquement de caract?riser l'impact des traitements viticoles (herbicides, fongicides, insecticides) sur les peuplements benthiques. Quatre stations d'?tude sont r?parties sur le cours d'eau en fonction des sources de pollution : une station de r?f?rence : station 1, une station hors vignoble mais ? l'aval d'un effluent de papeterie : station 2 et deux stations dans la zone viticole ? l'aval d'affluents traversant ?galement le vignoble : stations 3 et 4. La richesse taxonomique et les indices biologiques diminuent fortement dans la zone aval soumise aux pollutions diffuses. La structure des peuplements d'invert?br?s (98 taxons) a ?galement ?t? ?tudi?e au moyen d'une analyse factorielle des correspondances et d'une classification ascendante hi?rarchique. Quatre groupements faunistiques ont ainsi pu ?tre distingu?s : ? le premier (A) renferme les taxons rencontr?s sur le cours sup?rieur de l'Ardi?res (stations 1 et 2) dont les effectifs diminuent sur la station 2 (Heptageniidae, Elmidae, Gammaridae...) ; ? le deuxi?me (B) comprend les taxons propres ? la station de r?f?rence. Des taxons permettent de d?finir le niveau typologique du secteur (B3 : Baetis alpinus, Drusus annulatus, Rhyacophila tristis). D'autres tr?s sensibles ? la pollution (Epeorus torrentium, Ecdyonurus sp., Allogamus auricollis, Micrasema moestum...) soulignent la bonne qualit? biologique de ce secteur ; ? le troisi?me (C) englobe les taxons inf?od?s ? la station 2, confirmant le caract?re organique dominant de la perturbation de ce secteur (Halesus radiatus, Habrophlebia sp., Dasyhelea...) ; ? le quatri?me (D) est repr?sent? par les taxons communs ? tout le cours d'eau (Hydropsyche angustipennis, Baetis rhodani, Baetis fuscatus, Ephemerella ignita, Simuliidae, Chironomidae...). L'?tude de la structure des peuplements ? l'aide de courbes richesse sp?cifique-abondance permet une caract?risation des effets des diff?rents types de pollution rencontr?s sur les bioc?noses en place.This study has been carried out along the Ardi?res. The lower part of this river runs across a wine growing area where chemicals (herbicides, fungicides, insecticides) are intensively used and have caused a non-point pollution in the river. The purposes of this investigation are : 1) to assess the quality of the river, 2) to evaluate the effect of the toxic pollutants on macroinvertebrate communities and the response of some species to these toxins. The macrobenthos was collected at four stations from April to December 1991. The biotic index and the species richness are very low in the polluted lower part of the river. Correspondance Factorial Analysis applied to the 98 species recorded and a ascending hierarchical classification indicate four groups of species. ? The first group is composed of taxa living upstream (station 1 and 2) ; they are less abundant at the second station (Heptageniidae, Elmidae, Gammaridae). ? The species of the second group are restricted to the first station (Drusus annulatus, Baetis alpinus, Rhyacophila tristis,...). ? The third group includes species from the second station, many of them are generally tolerant of organic matter (Halesus radiatus, Habrophlebia sp., Dasyhelea,...). ? The last group is represented by the most euryecious species, that are living in the whole river (Hydropsyche angustipennis, Baetis rhodani, Baetis fuscatus, Ephemerella ignita, Simuliidae, Chironomidae...).

Published
1993

41. Le lac Vert : diagnose écologique et possibilités de restauration

Author

Barbe, J., Lavergne, Emilie, Cazin, B., and Irstea Publications, Migration

Subjects
[SDE] Environmental Sciences, CEMAGREF, LAC VERT, RHIN (HAUT), QELY
Abstract

Cet article résume l'essentiel des mesures faites sur le lac Vert et envisage les solutions les mieux adaptées pour une amélioration des conditions du milieu. Les paramètres étudiés sont la physicochimie de l'eau et des sédiments.

Published
1987

47. 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. Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial.

Author

Herling CD, Cymbalista F, Groß-Ophoff-Müller C, Bahlo J, Robrecht S, Langerbeins P, Fink AM, Al-Sawaf O, Busch R, Porcher R, Cazin B, Dreyfus B, Ibach S, Leprêtre S, Fischer K, Kaiser F, Eichhorst B, Wentner CM, Hoechstetter MA, Döhner H, Leblond V, Kneba M, Letestu R, Böttcher S, Stilgenbauer S, Hallek M, and Levy V

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cyclophosphamide administration & dosage, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell mortality, Male, Middle Aged, Neoplasm, Residual, Prospective Studies, Rituximab administration & dosage, Vidarabine administration & dosage, Vidarabine analogs & derivatives, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Leukemia, Lymphocytic, Chronic, B-Cell drug therapy
Abstract

We report a randomized prospective phase 3 study (CLL7), designed to evaluate the efficacy of fludarabine, cyclophosphamide, and rituximab (FCR) in patients with an early-stage high-risk chronic lymphocytic leukemia (CLL). Eight hundred patients with untreated-stage Binet A disease were enrolled as intent-to-treat population and assessed for four prognostic markers: lymphocyte doubling time <12 months, serum thymidine kinase >10 U/L, unmutated IGHV genes, and unfavorable cytogenetics (del(11q)/del(17p)/trisomy 12). Two hundred and one patients with ≥2 risk features were classified as high-risk CLL and 1:1 randomized to receive either immediate therapy with 6xFCR (Hi-FCR, 100 patients), or to be observed according to standard of care (Hi-W&W, 101 patients). The overall response rate after early FCR was 92.7%. Common adverse events were hematological toxicities and infections (61.0%/41.5% of patients, respectively). After median observation time of 55.6 (0-99.2) months, event-free survival was significantly prolonged in Hi-FCR compared with Hi-W&W patients (median not reached vs. 18.5 months, p < 0.001). There was no significant overall survival benefit for high-risk patients receiving early FCR therapy (5-year OS 82.9% in Hi-FCR vs. 79.9% in Hi-W&W, p = 0.864). In conclusion, although FCR is efficient to induce remissions in the Binet A high-risk CLL, our data do not provide evidence that alters the current standard of care "watch and wait" for these patients.

Published
2020
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49. Long-term follow up of the CLL2007FMP trial evaluating fludarabine and cyclophosphamide in combination with either rituximab or alemtuzumab in previously untreated patients with chronic lymphocytic leukemia.

Author

Feugier P, Aurran T, Mahé B, Letestu R, Nguyen-Khac F, Cazin B, Tournilhac O, Maisonneuve H, Casasnovas O, Delmer A, Leblond V, Royer B, Corront B, Chevret S, Delépine R, Vaudaux S, Van Den Neste E, Béné MC, Cymbalista F, Ross-Weil D, and Leprêtre S

Subjects
Antineoplastic Combined Chemotherapy Protocols adverse effects, Cyclophosphamide administration & dosage, Humans, Leukemia, Lymphocytic, Chronic, B-Cell mortality, Leukemia, Lymphocytic, Chronic, B-Cell pathology, Rituximab administration & dosage, Treatment Outcome, Vidarabine administration & dosage, Vidarabine analogs & derivatives, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Leukemia, Lymphocytic, Chronic, B-Cell drug therapy
Published
2018
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50. First-line therapy for chronic lymphocytic leukemia in patients older than 79 years is feasible and achieves good results: A FILO retrospective study.

Author

Meunier G, Ysebaert L, Nguyen-Thi PL, Lepretre S, Quinquenel A, Dupuis J, Lemal R, Aurran T, Tomowiak C, Cymbalista F, Dilhuydy MS, Brion A, Morel P, Cazin B, Leblond V, Cartron G, Ré D, Béné MC, Michallet AS, and Feugier P

Subjects
Age Factors, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Biomarkers, Chromosome Aberrations, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell diagnosis, Leukemia, Lymphocytic, Chronic, B-Cell mortality, Male, Mutation, Neoplasm Staging, Prognosis, Retrospective Studies, Socioeconomic Factors, Survival Analysis, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Leukemia, Lymphocytic, Chronic, B-Cell drug therapy
Abstract

The mean age at diagnosis of chronic lymphocytic leukemia (CLL) is 72 years, with 22.8% of patients being older than 80 years. However, the elderly are underrepresented in clinical studies of CLL. We performed a retrospective study of CLL patients aged 80 years or older at the initiation of first-line therapy in hospitals affiliated with the French intergroup on CLL (French Innovative Leukemia Organization) between 2003 and 2013. Here, we describe the clinical and biological characteristics, treatment, and outcomes for 201 patients. The median age of the cohort was 83.2 years (80-92 years). The median Cumulative Index Rating Scale comorbidity score was 5 and the median creatinine clearance was 48 mL/min (Cockcroft-Gault formula). At treatment initiation, Binet stage was A (26.4%), B (27.9%), or C (40.3%). Therapy consisted mainly of chlorambucil (65.7%), bendamustine (10.5%), and rituximab (44.3%) as follows: chlorambucil alone (45.3%) or immunochemotherapy (48.3%) with rituximab + chlorambucil (22.7%), rituximab + bendamustine (10.4%), or rituximab + cyclophosphamide + dexamethasone (5.5%). The overall response rate was 66.2% with 31.8% clinical complete remission. The median overall and progression-free survival from treatment initiation was 53.7 and 18.3 months, respectively. These results suggest that treatment is feasible in this age group, even with immunochemotherapy. Thus, prospective trials should target this population and oncogeriatric evaluation and new targeted therapies should be part of such future trials., (Copyright © 2016 John Wiley & Sons, Ltd.)

Published
2017
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