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2. Prognostic value of high-sensitivity measurable residual disease assessment after front-line chemoimmunotherapy in chronic lymphocytic leukemia

Author

Letestu, Rémi, Dahmani, Abdelmalek, Boubaya, Marouane, Baseggio, Lucile, Campos, Lydia, Chatelain, Bernard, Debliquis, Agathe, Drénou, Bernard, Jacob, Marie-Christine, Legac, Eric, Le Garff-Tavernier, Magali, Lhoumeau, Anne-Catherine, Quiney, Claire, Robillard, Nelly, Ticchioni, Michel, Aanei, Carmen, Katsahian, Sandrine, Delepine, Roselyne, Vaudaux, Sandrine, Rouillé, Valérie, Béné, Marie-Christine, Dartigeas, Caroline, Van Den Neste, Eric, Leprêtre, Stéphane, Feugier, Pierre, Cartron, Guillaume, Leblond, Véronique, Lévy, Vincent, Cymbalista, Florence, Cailleres, Sylvie, Damaj, Gandhi, Royer, Bruno, Gardembas, Martine, Dib, Mamoun, Truchan-Graczyk, Matgorzata, Hunault, Mathilde, Foussard, Charles, Corront, Bernadette, Parry, Anne, Orsini-Piocelle, Frédérique, Trouillier, Sébastien, Slama, Bohiane, Lepeu, Gérard, Zerazhi, Hacene, Boulat, Olivier, Azzedine, Ahmed, Araujo, Carla, Banos, Anne, Bauduer, Frédéric, Dutel, Jean-Luc, Ghomari, Kamel, Deconinck, Eric, Brion, Annie, Vuillier, Jacqueline, Saad, Alain, El Yamani, Abderrazak, Rodon, Philippe, Soubeyran, Pierre, Etienne, Gabriel, Dilhuydy, Marie-Sarah, Bouabdallah, Krimo, Leguay, Thibaut, Chouffi, Bachra, Pollet, Bertrand, Maakaroun, Abdallah, Guillerm, Gaëlle, Berthou, Christian, Cheron, Nathalie, ANDRÉ, Marc, Vilque, Jean Pierre, Fruchart, Christophe, Voillat, Laurent, Pica, Gian Matteo, Corm, Sélim, Micléa, Jean-Michel, Souleau, Bertrand, Molucon-Chabrot, Cécile, De Renzis, Benoit, Tournilhac, Olivier, Bay, Jacques-Olivier, Chaleteix, Carine, Guieze, Romain, Fleury, Joel, Precupanu, Cristina, Bouledroua, Selwa, Haiat, Stéphanie, Petitdidier, Charlotte, Dupuis, Jehan, Belhadj, Karim, Casasnovas, Olivier, Bastie, Jean-Noel, Ferrant, Emmanuelle, Gholam, Dany, Molina, Lysiane, Garban, Frédéric, Tiab, Mourad, Maisonneuve, Hervé, Villemagne, Bruno, Jacomy, Dominique, Besson, Caroline, Tertian, Gérard, Laribi, Kamel, Morel, Pierre, Cazin, Bruno, Moreau, Stéphane, Reminieras, Liliane, Rapp, Marie-José, Moreau, Philippe, Sebban, Catherine, Michallet, Anne-Sophie, Salles, Gilles, Broussais, Florence, Aurran-Schleinitz, Thérèse, Coso, Diane, Abarah, Wajed, Kulekci, Claire, Dorvaux, Véronique, Carassou, Philippe, Guibaud, Isabelle, Christian, Bernard, Graux, Carlos, Rossi, Jean-François, Quittet, Philippe, Dubois, Alain, Eisenmann, Jean-Claude, Morineau, Nadine, Mahé, Béatrice, Karsenti, Jean-Michel, Jourdan, Eric, Legouffe, Eric, Alexis-Vigier, Magda, Boulet, Jean-Michel, Aoudjhane, Malek, Thiéblemont, Catherine, Andreoli, Anna Lisa, Dreyfus, François, Choquet, Sylvain, Maloum, Karim, Merle-Béral, Hélène, Vekhoff, Anne, Decaudin, Didier, Brault, Philippe, Delarue, Richard, Janvier, Maud, Soussain, Carole, Vallantin, Xavier, Sanhes, Laurence, Dreyfus, Brigitte, Tomowiak, Cécile, Benramdane, Riad, Gonzalez, Hugo, Blaise-Brenna, Anne, Kolb, Brigitte, Delmer, Alain, Dauriac, Charles, Houot, Roch, Escoffre-Barbe, Martine, Lamy, Thierry, De Guibert, Sophie, Bernard, Marc, Grosbois, Bernard, Brehar, Oana, Morice, Patrick, Guyotat, Denis, Jaubert, Jérome, Portois, Christelle, Fornecker, Luc-Matthieu, Herbrecht, Raoul, Bilger, Karin, Ame, Shanti, Ysebaert, Loic, Godmer, Pascal, Jardel, Henry, Hôpital Avicenne [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), Hospices Civils de Lyon (HCL), CHU Saint-Etienne, CHU UCL Namur, Groupe hospitalier de la région de Mulhouse Sud-Alsace (GHRMSA), CHU Grenoble, Centre Hospitalier Régional d'Orléans (CHRO), CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Universitaire de Nice (CHU Nice), Hopital Saint-Louis [AP-HP] (AP-HP), Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Université Catholique de Louvain = Catholic University of Louvain (UCL), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Université de Montpellier (UM), UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - SSS/DDUV/BCHM - Biochimie-Recherche métabolique, UCL - (MGD) Laboratoire de biologie clinique, UCL - (SLuc) Service d'hématologie, Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), and Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)

Subjects
0301 basic medicine, Male, Cancer Research, Neoplasm, Residual, MESH: Immunotherapy, Chronic lymphocytic leukemia, Gastroenterology, MESH: Clinical Trials, Phase III as Topic, 0302 clinical medicine, Bone Marrow, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, MESH: Leukemia, Lymphocytic, Chronic, B-Cell, MESH: Aged, education.field_of_study, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, MESH: Follow-Up Studies, Prognosis, 3. Good health, Fludarabine, Survival Rate, Leukemia, MESH: Antineoplastic Combined Chemotherapy Protocols, medicine.anatomical_structure, Oncology, 030220 oncology & carcinogenesis, MESH: Vidarabine, MESH: Bone Marrow, Female, MESH: Rituximab, Immunotherapy, Rituximab, MESH: Clinical Trials, Phase II as Topic, Vidarabine, medicine.drug, medicine.medical_specialty, Cyclophosphamide, MESH: Survival Rate, Population, [SDV.CAN]Life Sciences [q-bio]/Cancer, MESH: Prognosis, 03 medical and health sciences, Clinical Trials, Phase II as Topic, Chemoimmunotherapy, Internal medicine, medicine, Humans, education, Survival rate, MESH: Neoplasm, Residual, Aged, Retrospective Studies, MESH: Humans, business.industry, MESH: Cyclophosphamide, MESH: Retrospective Studies, medicine.disease, Leukemia, Lymphocytic, Chronic, B-Cell, MESH: Male, body regions, 030104 developmental biology, Clinical Trials, Phase III as Topic, Bone marrow, business, MESH: Female, Follow-Up Studies
Abstract

International audience; Measurable residual disease (MRD) status is widely adopted in clinical trials in patients with chronic lymphocytic leukemia (CLL). Findings from FILO group trials (CLL2007FMP, CLL2007SA, CLL2010FMP) enabled investigation of the prognostic value of high-sensitivity (0.7 × 10-5) MRD assessment using flow cytometry, in blood (N = 401) and bone marrow (N = 339), after fludarabine, cyclophosphamide, and rituximab (FCR)-based chemoimmunotherapy in a homogeneous population with long follow-up (median 49.5 months). Addition of low-level positive MRD

Published
2020
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3. 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, Carmen D., Cymbalista, Florence, Gross-Ophoff-Mueller, Carolin, Bahlo, Jasmin, Robrecht, Sandra, Langerbeins, Petra, Fink, Anna-Maria, Al-Sawaf, Othman, Busch, Raymonde, Porcher, Raphael, Cazin, Bruno, Dreyfus, Brigitte, Ibach, Stefan, Lepretre, Stephane, Fischer, Kirsten, Kaiser, Florian, Eichhorst, Barbara, Wentner, Clemens-Martin, Hoechstetter, Manuela A., Doehner, Hartmut, Leblond, Veronique, Kneba, Michael, Letestu, Remi, Boettcher, Sebastian, Stilgenbauer, Stephan, Hallek, Michael, Levy, Vincent, Herling, Carmen D., Cymbalista, Florence, Gross-Ophoff-Mueller, Carolin, Bahlo, Jasmin, Robrecht, Sandra, Langerbeins, Petra, Fink, Anna-Maria, Al-Sawaf, Othman, Busch, Raymonde, Porcher, Raphael, Cazin, Bruno, Dreyfus, Brigitte, Ibach, Stefan, Lepretre, Stephane, Fischer, Kirsten, Kaiser, Florian, Eichhorst, Barbara, Wentner, Clemens-Martin, Hoechstetter, Manuela A., Doehner, Hartmut, Leblond, Veronique, Kneba, Michael, Letestu, Remi, Boettcher, Sebastian, Stilgenbauer, Stephan, Hallek, Michael, and Levy, Vincent

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

5. Early-onset invasive aspergillosis and other fungal infections in patients treated with ibrutinib

Author

Ghez, David, Calleja, Anne, Protin, Caroline, Baron, Marine, Ledoux, Marie-Pierre, Damaj, Gandhi, Dupont, Mathieu, Dreyfus, Brigitte, Ferrant, Emmanuelle, Herbaux, Charles, Laribi, Kamel, Le Calloch, Ronan, Malphettes, Marion, Paul, Franciane, Souchet, Laetitia, Truchan-Graczyk, Malgorzata, Delavigne, Karen, Dartigeas, Caroline, Ysebaert, Loïc, and on behalf on the French Innovative Leukemia Organization (FILO) CLL group

Published
2018
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6. Open Label Non-Randomized Phase II Study Exploring «Chemo-Free » Treatment Association with Idelalisib + Obinutuzumab in Patients with Relapsed/Refractory (R/R) Waldenstrom's Macroglobulinemia (MW), a Filo Trial: Results of the Intermediary Analysis of the Induction Phase

Author

Tomowiak, Cecile, primary, Desseaux, Kristell, primary, Poulain, Stéphanie, primary, Herbaux, Charles, primary, Perrot, Aurore, primary, Mahe, Beatrice, primary, Morel, Pierre, primary, Tournilhac, Olivier, primary, Lepretre, Stephane, primary, Aurran, Thérèse, primary, Villemagne, Bruno, primary, Casasnovas, Olivier, primary, Nollet, Delphine, primary, Dreyfus, Brigitte, primary, Chevret, Sylvie, primary, and Leblond, Veronique, primary

Published
2019
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8. p53 Functional Assessment and Correlation with 17p Deletion and/or TP53 Mutation Status: Final Report of the ICLL001 Bomp Trial

Author

Le Garff-Tavernier, Magali, primary, Quiney, Claire, additional, Veronese, Lauren, additional, Nguyen-Khac, Florence, additional, Robbe, Pauline, additional, Combes, Patricia, additional, Dilhuydy, Marie-Sarah, additional, Feugier, Pierre, additional, Mahe, Beatrice, additional, Sanhes, Laurence, additional, Delmer, Alain Jacques, additional, Ysebaert, Loic, additional, Truchan-Graczyk, Malgorzata, additional, Dreyfus, Brigitte, additional, Sylvain, Choquet, additional, Aurran, Thérèse, additional, Ferrant, Emmanuelle, additional, Dartigeas, Caroline, additional, Leprêtre, Stéphane, additional, Pica, Gian Matteo, additional, Davi, Frederic, additional, Pereira, Bruno, additional, Delepine, Roselyne, additional, Schuh, Anna, additional, Guieze, Romain, additional, Bay, Jacques-Olivier, additional, Leblond, Véronique, additional, Merle-Beral, Helene, additional, de Guibert, Sophie, additional, and Tournilhac, Olivier, additional

Published
2018
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9. Oral CHOP-like Chemotherapy in Elderly Patients with High-Grade Non Hodgkin B Cell Lymphoma

Author

Guidez, Stephanie, primary, Tomowiak, Cecile, additional, Princet, Isabelle, additional, Dreyfus, Brigitte, additional, Olivier, Gaelle, additional, Fleck, Emmanuel, additional, Corby, Anne, additional, Motard, Carine, additional, Machet, Antoine, additional, Debiais, Celine, additional, Leleu, Xavier, additional, Guilhot, Joelle, additional, and Delwail, Vincent, additional

Published
2018
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10. Ofatumumab retreatment and maintenance in fludarabine-refractory chronic lymphocytic leukaemia patients

Author

Osterborg, Anders, Wierda, William G., Mayer, Jiri, Hess, Georg, Hillmen, Peter, Schetelig, Johannes, Schuh, Anna, Smolej, Lukas, Beck, Christian, Dreyfus, Brigitte, Hellman, Andrzej, Kozlowski, Piotr, Pfreundschuh, Michael, Rizzi, Rita, Spacek, Martin, Phillips, Jennifer L., Gupta, Ira V., Williams, Vanessa, Jewell, Roxanne C., Nebot, Noelia, Lisby, Steen, Dyer, Martin J. S., Osterborg, Anders, Wierda, William G., Mayer, Jiri, Hess, Georg, Hillmen, Peter, Schetelig, Johannes, Schuh, Anna, Smolej, Lukas, Beck, Christian, Dreyfus, Brigitte, Hellman, Andrzej, Kozlowski, Piotr, Pfreundschuh, Michael, Rizzi, Rita, Spacek, Martin, Phillips, Jennifer L., Gupta, Ira V., Williams, Vanessa, Jewell, Roxanne C., Nebot, Noelia, Lisby, Steen, and Dyer, Martin J. S.

Abstract

There are limited data on retreatment with monoclonal antibodies (mAb) in patients with chronic lymphocytic leukaemia (CLL). In a pivotal study, ofatumumab (human anti-CD20 mAb) monotherapy demonstrated a 47% objective response rate (ORR) in fludarabine refractory CLL patients. From this study, a subset of 29 patients who had at least stable disease and then progressed were retreated with eight weekly ofatumumab infusions (induction treatment period), followed by monthly infusions for up to 2years (maintenance treatment period). The ORR after 8weeks of induction retreatment was 45% and 24% had continued disease control after maintenance at 52weeks. Efficacy and safety of the retreated patients were compared with their initial results in the pivotal study. Response duration was 241months vs. 68months; time to next therapy was 148months vs. 123months; and progression-free survival was 74months vs. 79months (medians). Upon retreatment, 72% had infusion reactions, mostly Grade 1-2. Three patients had fatal infections. In summary, ofatumumab retreatment and maintenance therapy was feasible in patients with heavily pretreated CLL and appeared to result in more durable disease control than initial ofatumumab treatment in this subset of patients who may have a more favourable disease profile.

Published
2015
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11. gene mutational status and / gene expression as clinical outcome predictors in CLL patients in remission following treatment with oral fludarabine plus cyclophosphamide

Author

Maloum, Karim, Settegrana, Catherine, Chapiro, Elise, Cazin, Bruno, Leprêtre, Stéphane, Delmer, Alain, Leporrier, Michel, Dreyfus, Brigitte, Tournilhac, Olivier, Mahe, Beatrice, Nguyen-Khac, Florence, Lesty, Claude, Davi, Frederic, Merle-Béral, Hélène, CHU Pitié-Salpêtrière [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Service des maladies du sang, Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel), Université de Reims Champagne-Ardenne (URCA), Laboratoire d'Hématologie Biologique [CHU Caen], Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN), Service d'Hématologie Clinique, CHU La Milétrie, Service d’Hématologie Biologique [CHU Clermont-Ferrand], CHU Gabriel Montpied [Clermont-Ferrand], CHU Clermont-Ferrand-CHU Clermont-Ferrand-CHU Estaing [Clermont-Ferrand], CHU Clermont-Ferrand, Service Hématologie Clinique, CHU Hotel Dieu, Service d'hématologie biologique [CHU Pitié-Salpêtrière], Université Pierre et Marie Curie - Paris 6 (UPMC)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Pitié-Salpêtrière [AP-HP], and Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU)

Subjects
Oral fludarabine, Mutational status, Cyclophosphamide, CLL
Abstract

International audience; Several prognostic factors can predict the rapid progression in chronic lymphocytic leukaemia (CLL), including mutational status, cytogenetic abnormalities and, more recently, / expression. In contrast, few studies have been devoted to the influence of these factors on clinical outcome in responding patients after therapy. We here propose to analyse the impact of gene status, and gene expression on disease-free survival (DFS) and overall survival (OS) in 41 stage B or C CLL patients in remission after oral fludarabine plus cyclophosphamide. The median follow-up was of 64 (16–74) months. Sequencing of showed mutated (M) genes in 16 of 41 cases and unmutated (UM) in 25 cases. Analysis of and expression in 35 of 41 cases showed overexpression of in 17 cases (14 M and three UM) and in 18 cases (all UM). Patients expressing UM and had shorter DFS and OS when compared to patients expressing M and/or . Furthermore, blood minimal residual disease (MRD) evaluation using four-colour flow cytometry was performed in 33 out the 41 patients. We showed that patients who achieved phenotypic remission displayed longer DFS than those with MRD. Our results support the use of and gene expression associated to mutational status for predicting the clinical outcome of patients treated by oral fludarabine + cyclophosphamide and could be considered for treatment strategies.

Published
2009
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12. Dynamic of Telomeric Parameters in Relapsing or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL), an Analysis of the Filo ICLL001 Bomp Trial

Author

Bounaix, Laura, Tchirkov, Andrei, Nguyen-Khac, Florence, Combes, Patricia, Feugier, Pierre, Sanhes, Laurence, Dilhuydy, Marie-Sarah, Saad, Hussam, Ysebaert, Loic, Sylvain, Choquet, Vilque, Jean-Pierre, Brion, Annie, Araujo, Carla, Ferrant, Emmanuelle, Dreyfus, Brigitte, Delmer, Alain Jacques, Truchan-Graczyk, Malgorzata, Leprêtre, Stéphane, de Guibert, Sophie, Guieze, Romain, Veronese, Lauren, Lemal, Richard, Vago, Philippe, Bay, Jacques-Olivier, Berger, Marc G., Schuh, Anna, Ferrand, Christophe, Delepine, Roselyne, Leblond, Véronique, and Tournilhac, Olivier

Published
2017
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13. Bendamustine, Ofatumumab and High-Dose Methylprednisolone (BOMP) in Relapsed/Refractory CLL: Results of a Planned Interim Analysis of the French CLL Intergroup ICLL01 Phase II Trial

Author

de Guibert, Sophie, primary, Dilhuydy, Marie-Sarah, additional, Ysebaert, Loic, additional, Sanhès, Laurence, additional, Choquet, Sylvain, additional, Aurran-Schleinitz, Therese, additional, Guieze, Romain, additional, Mahe, Beatrice, additional, Daguindau, Nicolas, additional, Araujo, Carla, additional, Saad, Hussam, additional, Ferrant, Emmanuelle, additional, Cazin, Bruno, additional, Feugier, Pierre, additional, Dreyfus, Brigitte, additional, Alain, Delmer, additional, Lepretre, Stéphane, additional, Le Garff-Tavernier, Magali, additional, Lauren, Véronese, additional, Schuh, Anna, additional, Pereira, Bruno, additional, Leblond, Veronique, additional, and Tournilhac, Olivier, additional

Published
2014
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14. Use of Human Immunoglobulins in Secondary Immunodeficiencies Associated with Hematological Malignancy in Real-Life Practice: Which Patients, Which Treatment?

Author

Benbrahim, Omar, primary, Grosbois, Bernard, additional, Viallard, Jean-François, additional, Choquet, Sylvain, additional, Royer, Bruno, additional, Dreyfus, Brigitte, additional, Fleck, Emmanuel, additional, Carreiro, Miguel, additional, Clerson, Pierre, additional, Crave, Jean Charles, additional, Delain, Jean-christophe, additional, and Levy, Vincent, additional

Published
2014
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15. 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 – First Results Of a Randomized German-French Cooperative Phase III Trial

Author

Schweighofer, Carmen D, primary, Cymbalista, Florence, additional, Müller, Carolin, additional, Busch, Raymonde, additional, Porcher, Raphael, additional, Langerbeins, Petra, additional, Cazin, Bruno, additional, Fink, Anna-Maria, additional, Dreyfus, Brigitte, additional, Ibach, Stefan, additional, Leprêtre, Stéphane, additional, Fischer, Kirsten, additional, Vehling-Kaiser, Ursula, additional, Eichhorst, Barbara, additional, Bergmann, Manuela A., additional, Stilgenbauer, Stephan, additional, Döhner, Hartmut, additional, Leblond, Veronique, additional, Hallek, Michael, additional, and Levy, Vincent, additional

Published
2013
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16. Phase II Trial In Advanced Waldenstrom Macroglobulinemia (WM) Patients With Bortezomib: Interest Of Addition Of Dexamethasone To Bortezomib On Behalf Of The French CLL/WM Intergroup (NCT 00777738)

Author

Leblond, Veronique, primary, Chevret, Sylvie, additional, Dilhuydy, marie Sarah, additional, Leleu, Xavier, additional, Soussain, Carole, additional, Leprêtre, Stéphane, additional, Dreyfus, Brigitte, additional, Dartigeas, Caroline, additional, Mahe, Beatrice, additional, Anglaret, Bruno, additional, Pegourie, Brigitte, additional, Besson, Caroline, additional, Aurran, Therese, additional, Vekhoff, Anne, additional, Tournilhac, Olivier, additional, Banos, Anne, additional, Oya, Herve, additional, Lejeune, Julie, additional, and Morel, Pierre, additional

Published
2013
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17. P53 Functional Assessment and Correlation With 17p Deletion and/Or TP53 Mutation Status In Chronic Lymphocytic Leukemia (CLL). A Preliminary Report Of The ICLL001 Bomp Trial On Behalf Of The French CLL Intergroup (GCFLLC/MW - GOELAMS)

Author

Le Garff-Tavernier, Magali, primary, Veronese, Lauren, additional, Nguyen-Khac, Florence, additional, Dilhuydy, Marie-Sarah, additional, Combes, Patricia, additional, Leblond, Véronique, additional, Feugier, Pierre, additional, Mahe, Beatrice, additional, Sanhès, Laurence, additional, Delmer, Alain, additional, Ysebaert, Loic, additional, Grelier, Aurore, additional, Truchan-Graczyk, Malgorzata, additional, Dreyfus, Brigitte, additional, Ferrant, Emmanuelle, additional, Leprêtre, Stéphane, additional, Davi, Frederic, additional, Pereira, Bruno, additional, Delepine, Roselyne, additional, Guièze, Romain, additional, Bay, Jacques-Olivier, additional, Merle-Beral, Helene, additional, De Guibert, Sophie, additional, and Tournilhac, Olivier, additional

Published
2013
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18. Consolidation Therapy with Subcutaneous Alemtuzumab After Induction Treatment with Oral FC (Fludarabine and Cyclophosphamide) in Previously Untreated Patients Aged 65–70 Years with Advanced Stage Chronic Lymphocytic Leukemia (CLL): Final Results of a Phase II Study From the FCGCLL/WM,

Author

Delmer, Alain, primary, Tournilhac, Olivier, additional, Leprêtre, Stéphane, additional, Cazin, Bruno, additional, Feugier, Pierre, additional, Dreyfus, Brigitte, additional, Mahe, Beatrice, additional, Leporrier, Michel, additional, Michallet, Anne-Sophie, additional, Jaccard, Arnaud, additional, Divine, Marine, additional, Levy, Vincent, additional, Cymbalista, Florence, additional, and Letestu, Remi, additional

Published
2011
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19. Consolidation Therapy with Subcutaneous Alemtuzumab Following Induction Treatment with Oral FC (Fludarabine and Cyclophosphamide) in Previously Untreated Patients Aged 65-70 Years with Advanced Stage Chronic Lymphocytic Leukemia (CLL): A Phase II Trial of the FCGCLL/MW.

Author

Delmer, Alain, primary, Leprêtre, Stéphane, additional, Cazin, Bruno, additional, Feugier, Pierre, additional, Tournilhac, Olivier, additional, Leporrier, Michel, additional, Dreyfus, Brigitte, additional, Mahé, Béatrice, additional, Thieblemont, Catherine, additional, Divine, Marine, additional, Lévy, Vincent, additional, Leblond, Véronique, additional, Cymbalista, Florence, additional, and Letestu, Rémy, additional

Published
2006
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20. Autologous Stem Cell Transplantation (ASCT) Versus Standard Treatments for CLL Patients: First Interim Analysis of a Prospective Randomized Study from the French Cooperative Study Group on CLL.

Author

Sutton, Laurent, primary, Diviné, Marine, primary, Travade, Philippe, primary, Martin, Claude, primary, Leprêtre, Stéphane, primary, Gonzalez, Hugo, primary, Van den Neste, Eric, primary, Michallet, Mauricette, primary, Cymbalista, Florence, primary, Maloisel, Frédéric, primary, Leblond, Véronique, primary, Eghbali, Houchingue, primary, Berthout, Michel, primary, Decaudin, Didier, primary, Dreyfus, Brigitte, primary, Cazin, Bruno, primary, Bouabdallah, Krimo, primary, Pharm, Anne Drihème, primary, Merle-Béral, Hélène, primary, and Leporrier, Michel, primary

Published
2005
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21. IGHV gene mutational status and LPL/ ADAM29 gene expression as clinical outcome predictors in CLL patients in remission following treatment with oral fludarabine plus cyclophosphamide.

Author

Maloum, Karim, Settegrana, Catherine, Chapiro, Elise, Cazin, Bruno, Leprêtre, Stéphane, Delmer, Alain, Leporrier, Michel, Dreyfus, Brigitte, Tournilhac, Olivier, Mahe, Beatrice, Nguyen-Khac, Florence, Lesty, Claude, Davi, Frederic, and Merle-Béral, Hélène

Subjects
CHRONIC lymphocytic leukemia, CYTOGENETICS, CYCLOPHOSPHAMIDE, FLUDARABINE, FLOW cytometry, GENE expression
Abstract

Several prognostic factors can predict the rapid progression in chronic lymphocytic leukaemia (CLL), including IGHV mutational status, cytogenetic abnormalities and, more recently, LPL/ ADAM29 expression. In contrast, few studies have been devoted to the influence of these factors on clinical outcome in responding patients after therapy. We here propose to analyse the impact of IGHV gene status, LPL and ADAM29 gene expression on disease-free survival (DFS) and overall survival (OS) in 41 stage B or C CLL patients in remission after oral fludarabine plus cyclophosphamide. The median follow-up was of 64 (16–74) months. Sequencing of IGHV showed mutated (M) VH genes in 16 of 41 cases and unmutated (UM) in 25 cases. Analysis of LPL and ADAM29 expression in 35 of 41 cases showed overexpression of ADAM29 in 17 cases (14 M and three UM) and LPL in 18 cases (all UM). Patients expressing UM IGHV and LPL had shorter DFS and OS when compared to patients expressing M IGHV and/or ADAM29. Furthermore, blood minimal residual disease (MRD) evaluation using four-colour flow cytometry was performed in 33 out the 41 patients. We showed that patients who achieved phenotypic remission displayed longer DFS than those with MRD+. Our results support the use of LPL and ADAM29 gene expression associated to IGHV mutational status for predicting the clinical outcome of patients treated by oral fludarabine + cyclophosphamide and could be considered for treatment strategies. [ABSTRACT FROM AUTHOR]

Published
2009
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22. p53 Functional Assessment and Correlation with 17p Deletion and/or TP53Mutation Status: Final Report of the ICLL001 Bomp Trial

Author

Le Garff-Tavernier, Magali, Quiney, Claire, Veronese, Lauren, Nguyen-Khac, Florence, Robbe, Pauline, Combes, Patricia, Dilhuydy, Marie-Sarah, Feugier, Pierre, Mahe, Beatrice, Sanhes, Laurence, Delmer, Alain Jacques, Ysebaert, Loic, Truchan-Graczyk, Malgorzata, Dreyfus, Brigitte, Sylvain, Choquet, Aurran, Thérèse, Ferrant, Emmanuelle, Dartigeas, Caroline, Leprêtre, Stéphane, Pica, Gian Matteo, Davi, Frederic, Pereira, Bruno, Delepine, Roselyne, Schuh, Anna, Guieze, Romain, Bay, Jacques-Olivier, Leblond, Véronique, Merle-Beral, Helene, de Guibert, Sophie, and Tournilhac, Olivier

Abstract

Introduction: The 17p deletion (del(17p)) resulting in loss of the TP53gene is associated with impaired response to genotoxic agents and has an impact on PFS following BTK inhibitor and possibly also venetoclax. The del(17p) usually coincides with TP53mutation, leading to the impairment of the p53-associated pathway. Sole TP53mutations appear also associated with poor outcome in prospective trials. The iwCLL guidelines recommend to look for del(17p) and TP53mutation before each line of treatment. An original approach is the functional assay, which highlights the functional abnormalities of p53 whether it is a TP53gene disruption (del(17p) and/or TP53mutation) or a defect of another actor in the p53 pathway. We aim to validate this functional assay on a prospective trial and to study the impact of p53 status on the clinical response regardless of the biological method.

Published
2018
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23. P53 Functional Assessment and Correlation With 17p Deletion and/Or TP53Mutation Status In Chronic Lymphocytic Leukemia (CLL). A Preliminary Report Of The ICLL001 Bomp Trial On Behalf Of The French CLL Intergroup (GCFLLC/MW - GOELAMS)

Author

Le Garff-Tavernier, Magali, Veronese, Lauren, Nguyen-Khac, Florence, Dilhuydy, Marie-Sarah, Combes, Patricia, Leblond, Véronique, Feugier, Pierre, Mahe, Beatrice, Sanhès, Laurence, Delmer, Alain, Ysebaert, Loic, Grelier, Aurore, Truchan-Graczyk, Malgorzata, Dreyfus, Brigitte, Ferrant, Emmanuelle, Leprêtre, Stéphane, Davi, Frederic, Pereira, Bruno, Delepine, Roselyne, Guièze, Romain, Bay, Jacques-Olivier, Merle-Beral, Helene, De Guibert, Sophie, and Tournilhac, Olivier

Abstract

Despite improvement in treatment strategies, virtually all chronic lymphocytic leukemia (CLL) patients will relapse and experience tumor resistance. The 17p deletion resulting in loss of the TP53gene, found in up to 20-40% of relapsing patients, is strongly associated with impaired response to genotoxic agents, reduced progression free survival and poor overall survival. The 17p deletion usually coincides with TP53mutation, leading to the impairment of the p53-associated pathway. In addition, sole TP53mutations (without 17p deletion) appear also associated with poor outcome in prospective trials. However, TP53mutation screening is time consuming, can be not exhaustive, and the respective impact of different patterns of TP53gene impairment on p53 function and prognostic remains unclear. We previously developed a functional assay to detect p53 dysfunction (Le Garff-Tavernier, 2011) and we aim to validate this analysis on a large prospective trial.

Published
2013
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25. Allogeneic hematopoietic stem cell transplantation allows long-term complete remission and curability in high-risk Waldenström’s macroglobulinemia. Results of a retrospective analysis of the Société Française de Greffe de Moelle et de Thérapie Cellulaire.

Author

Garnier A, Robin M, Larosa F, Golmard JL, Le Gouill S, Coiteux V, Tabrizi R, Bulabois CE, Cacheux V, Kuentz M, Dreyfus B, Dreger P, Rio B, Moles-Moreau MP, Bilger K, Bay JO, Leblond V, Blaise D, Tournilhac O, and Dhédin N

Subjects
Adult, Disease-Free Survival, Female, Follow-Up Studies, France, Humans, Male, Middle Aged, Remission Induction, Retrospective Studies, Risk Factors, Time Factors, Transplantation, Homologous, Treatment Outcome, Waldenstrom Macroglobulinemia mortality, Waldenstrom Macroglobulinemia pathology, Young Adult, Hematopoietic Stem Cell Transplantation methods, Societies, Medical, Waldenstrom Macroglobulinemia surgery
Abstract

Background: Patients with poor-risk Waldenström's macroglobulinemia have suboptimal response and early post-treatment relapse with conventional therapies. Hence, new therapeutic approaches such as allogeneic stem cell transplantation should be evaluated in these patients., Design and Methods: We examined the long-term outcome of allogeneic stem cell transplantation in Waldenström's macroglobulinemia by studying the records of 24 patients reported in the SFGM-TC database and one transplanted in the bone marrow unit in Hamburg., Results: Median age at the time of transplant was 48 years (range, 24-64). The patients had previously received a median of 3 lines of therapy (range, 1-6) and 44% of them had refractory disease at time of transplant. Allogeneic stem cell transplantation after myeloablative (n=12) or reduced-intensity (n=13) conditioning yielded an overall response rate of 92% and immunofixation-negative complete remission in 50% of evaluable patients. With a median follow-up of 64 months among survivors (range, 11-149 months), 5-year overall survival and progression-free survival rates were respectively, 67% (95% CI: 46-81) and 58% (95% CI: 38-75). The 5-year estimated risk of progression was 25% (95% CI: 10-36%), with only one relapse among the 12 patients who entered complete remission, versus 5 in the 12 patients who did not. Only one of the 6 relapses occurred more than three years post-transplant., Conclusions: Allogeneic stem cell transplantation yields a high rate of complete remissions and is potentially curative in poor-risk Waldenström's macroglobulinemia.

Published
2010
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