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1. Blinatumomab after R-CHOP bridging therapy for patients with Richter transformation: a phase 2 multicentre trial

Author

Guièze, Romain, Ysebaert, Loïc, Roos-Weil, Damien, Fornecker, Luc-Mathieu, Ferrant, Emmanuelle, Molina, Lysiane, Aurran, Thérèse, Clavert, Aline, de Guibert, Sophie, Michallet, Anne-Sophie, Saad, Alain, Drénou, Bernard, Quittet, Philippe, Hivert, Bénédicte, Laribi, Kamel, Gay, Julie, Quinquenel, Anne, Broseus, Julien, Rouille, Valérie, Schwartz, David, Magnin, Benoit, Lazarian, Grégory, Véronèse, Lauren, de Antonio, Marie, Laurent, Camille, Tournilhac, Olivier, Pereira, Bruno, and Feugier, Pierre

Published
2024
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2. Real-world outcomes following venetoclax therapy in patients with chronic lymphocytic leukemia or Richter syndrome: a FILO study of the French compassionate use cohort

Author

Bouclet, Florian, Calleja, Anne, Dilhuydy, Marie-Sarah, Véronèse, Lauren, Pereira, Bruno, Amorim, Sandy, Cymbalista, Florence, Herbaux, Charles, de Guibert, Sophie, Roos-Weil, Damien, Hivert, Bénédicte, Aurran, Thérèse, Dupuis, Jehan, Blouet, Anaise, Tchernonog, Emmanuelle, Laribi, Kamel, Dmytruck, Nataliya, Morel, Pierre, Michallet, Anne-Sophie, Dartigeas, Caroline, Tournilhac, Olivier, Nguyen-Khac, Florence, Delmer, Alain, Feugier, Pierre, Ysebaert, Loïc, and Guièze, Romain

Published
2021
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3. A Real-World Investigation of MRI Changes in Bone in Patients with Type 1 Gaucher Disease Treated with Velaglucerase Alfa: The EIROS Study.

Author

Bengherbia, Monia, Berger, Marc, Hivert, Bénédicte, Rigaudier, Florian, Bracoud, Luc, Vaeterlein, Ole, Yousfi, Karima, Maric, Michele, Malcles, Marie, and Belmatoug, Nadia

Subjects
GAUCHER'S disease, MAGNETIC resonance imaging, LUMBAR vertebrae, BONE marrow, BONE diseases, THERAPEUTICS
Abstract

Background/Objectives: Gaucher disease type 1 (GD1) is characterized by hepatosplenomegaly, thrombocytopenia, and disabling bone manifestations requiring regular MRI monitoring. The EIROS study assessed the real-world impact of velaglucerase alfa on GD1 bone disease, using MRI data collected in French clinical practice. Methods: MRIs collected retrospectively from treatment initiation and prospectively during follow-up (12-months) were analyzed centrally by a blinded expert radiologist to evaluate bone infiltration using the Bone Marrow Burden (BMB) score and a qualitative method (stable, improved or worsened for the spine and femur). Abdominal MRIs were also centrally analyzed to assess hepatosplenomegaly. Bone manifestations, hepatosplenomegaly, and hematologic parameters were analyzed from medical records. Results: MRI data were available for 20 patients: 6 treatment-naive patients and 14 patients who switched to velaglucerase alfa from another GD treatment. Interpretable MRIs for BMB scoring were available for seven patients for the spine and one patient for the femur. Qualitative assessments (n = 18) revealed stability in spine and femur infiltration in 100.0% and 84.6% of treatment-switched patients (n = 13), respectively, and improvements in 80.0% and 60.0% of treatment-naive patients (n = 5), respectively; no worsening of bone infiltration was observed. Liver, spleen, and hematologic parameters improved in treatment-naive patients and remained stable in treatment-switched patients. Conclusions: The qualitative real-world data support findings from clinical trials suggesting the long-term effectiveness of velaglucerase alfa on GD1 bone manifestations. When MRI assessment by radiologists with experience of GD is not possible, a simplified qualitative assessment may be sufficient in clinical practice for monitoring bone disease progression and treatment response. [ABSTRACT FROM AUTHOR]

Published
2024
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6. A revised international prognostic score system for Waldenström’s macroglobulinemia

Author

Kastritis, Efstathios, Morel, Pierre, Duhamel, Alain, Gavriatopoulou, Maria, Kyrtsonis, Marie Christine, Durot, Eric, Symeonidis, Argiris, Laribi, Kamel, Hatjiharissi, Evdoxia, Ysebaert, Loic, Vassou, Amalia, Giannakoulas, Nikolaos, Merlini, Giampaolo, Repousis, Panagiotis, Varettoni, Marzia, Michalis, Euridyki, Hivert, Bénédicte, Michail, Michalis, Katodritou, Eirini, Terpos, Evangelos, Leblond, Veronique, and Dimopoulos, Meletios A.

Published
2019
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7. Clinical characteristics and outcome of 318 families with familial monoclonal gammopathy: A multicenter Intergroupe Francophone du Myélome study.

Author

UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Dumontet, Charles, Demangel, Delphine, Galia, Perrine, Karlin, Lionel, Roche, Laurent, Fauvernier, Mathieu, Golfier, Camille, Laude, Marie-Charlotte, Leleu, Xavier, Rodon, Philippe, Roussel, Murielle, Azaïs, Isabelle, Doyen, Chantal, Slama, Borhane, Manier, Salomon, Decaux, Olivier, Pertesi, Maroulio, Beaumont, Marie, Caillot, Denis, Boyle, Eileen M, Cliquennois, Manuel, Cony-Makhoul, Pascale, Doncker, Anne-Violaine, Dorvaux, Véronique, Petillon, Marie Odile, Fontan, Jean, Hivert, Bénédicte, Leduc, Isabelle, Leyronnas, Cécile, Macro, Margaret, Maigre, Michel, Mariette, Clara, Mineur, Philippe, Rigaudeau, Sophie, Royer, Bruno, Vincent, Laure, Mckay, James, Perrial, Emeline, Garderet, Laurent, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Dumontet, Charles, Demangel, Delphine, Galia, Perrine, Karlin, Lionel, Roche, Laurent, Fauvernier, Mathieu, Golfier, Camille, Laude, Marie-Charlotte, Leleu, Xavier, Rodon, Philippe, Roussel, Murielle, Azaïs, Isabelle, Doyen, Chantal, Slama, Borhane, Manier, Salomon, Decaux, Olivier, Pertesi, Maroulio, Beaumont, Marie, Caillot, Denis, Boyle, Eileen M, Cliquennois, Manuel, Cony-Makhoul, Pascale, Doncker, Anne-Violaine, Dorvaux, Véronique, Petillon, Marie Odile, Fontan, Jean, Hivert, Bénédicte, Leduc, Isabelle, Leyronnas, Cécile, Macro, Margaret, Maigre, Michel, Mariette, Clara, Mineur, Philippe, Rigaudeau, Sophie, Royer, Bruno, Vincent, Laure, Mckay, James, Perrial, Emeline, and Garderet, Laurent

Abstract

Familial forms of monoclonal gammopathy, defined as multiple myeloma (MM) or Monoclonal Gammopathy of Undetermined Significance (MGUS), are relatively infrequent and most series reported in the literature describe a limited number of families. MM rarely occurs in a familial context. MGUS is observed much more commonly, which can in some cases evolve toward full-blown MM. Although recurrent cytogenetic abnormalities have been described in tumor cells of sporadic cases of MM, the pathogenesis of familial MM remains largely unexplained. In order to identify genetic factors predisposing to familial monoclonal gammopathy, the Intergroupe Francophone du Myélome identified 318 families with at least two confirmed cases of monoclonal gammopathy. There were 169 families with parent/child pairs and 164 families with cases in at least two siblings, compatible with an autosomal transmission. These familial cases were compared with sporadic cases who were matched for age at diagnosis, sex and immunoglobulin isotype, with 10 sporadic cases for each familial case. The gender distribution, age and immunoglobulin subtypes of familial cases were unremarkable in comparison to sporadic cases. With a median follow-up of 7.4 years after diagnosis, the percentage of MGUS cases having evolved to MM was 3%. The median overall survival of the 148 familial MM cases was longer than that of matched sporadic cases, with projected values of 7.6 and 16.1 years in patients older and younger than 65 years, respectively. These data suggest that familial cases of monoclonal gammopathy are similar to sporadic cases in terms of clinical presentation and carry a better prognosis.

Published
2023

8. Clinical characteristics and outcome of 318 families with familial monoclonal gammopathy: A multicenter Intergroupe Francophone du Myélome study

Author

Dumontet, Charles, primary, Demangel, Delphine, additional, Galia, Perrine, additional, Karlin, Lionel, additional, Roche, Laurent, additional, Fauvernier, Mathieu, additional, Golfier, Camille, additional, Laude, Marie‐Charlotte, additional, Leleu, Xavier, additional, Rodon, Philippe, additional, Roussel, Murielle, additional, Azaïs, Isabelle, additional, Doyen, Chantal, additional, Slama, Borhane, additional, Manier, Salomon, additional, Decaux, Olivier, additional, Pertesi, Maroulio, additional, Beaumont, Marie, additional, Caillot, Denis, additional, Boyle, Eileen M., additional, Cliquennois, Manuel, additional, Cony‐Makhoul, Pascale, additional, Doncker, Anne‐Violaine, additional, Dorvaux, Véronique, additional, Petillon, Marie Odile, additional, Fontan, Jean, additional, Hivert, Bénédicte, additional, Leduc, Isabelle, additional, Leyronnas, Cécile, additional, Macro, Margaret, additional, Maigre, Michel, additional, Mariette, Clara, additional, Mineur, Philippe, additional, Rigaudeau, Sophie, additional, Royer, Bruno, additional, Vincent, Laure, additional, Mckay, James, additional, Perrial, Emeline, additional, and Garderet, Laurent, additional

Published
2023
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10. Preliminary Results of the Filo Phase 2 Trial for Untreated Fit Patients with Intermediate Risk Chronic Lymphocytic Leukemia Comparing Ibrutinib Plus Venetoclax (IV) Versus FCR: Results of the Month 15 MRD Evaluation

Author

Quinquenel, Anne, primary, Letestu, Rémi, additional, Le Garff-Tavernier, Magali, additional, Subtil, Fabien, additional, Aurran-Schleinitz, Therese, additional, Laribi, Kamel, additional, Cymbalista, Florence, additional, Levy, Vincent, additional, Simon, Laurence, additional, Roos-Weil, Damien, additional, Leblond, Véronique, additional, Dilhuydy, Marie-Sarah, additional, Dartigeas, Caroline, additional, Tomowiak, Cecile, additional, Guieze, Romain, additional, Tournilhac, Olivier, additional, Ferrant, Emmanuelle, additional, de Guibert, Sophie, additional, Feugier, Pierre, additional, Merabet, Fatiha, additional, Lepretre, Stephane, additional, Carassou, Philippe, additional, Gay, Julie, additional, Hivert, Bénédicte, additional, Fornecker, Luc Mathieu, additional, Dupuis, Jehan, additional, Molina, Lysiane, additional, Villemagne, Bruno, additional, Cartron, Guillaume, additional, Drenou, Bernard, additional, Mahé, Béatrice, additional, Benbrahim, Omar, additional, Cahu, Xavier, additional, Portois, Christelle, additional, Ysebaert, Loic, additional, Nguyen Khac, Florence, additional, Rouille, Valérie, additional, Delmer, Alain, additional, and Michallet, Anne-Sophie, additional

Published
2022
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11. High frequency of central nervous system involvement in transformed Waldenstrom macroglobulinemia

Author

Cancer Research UK, Asociación Española Contra el Cáncer, Durot, Eric, Kanagaratnam, Lukshe, Zanwar, Saurabh, Toussaint, Elise, Kastritis, Efstathios, D’Sa, Shirley, Alcoceba, Miguel, Tomowiak, Cécile, Hivert, Bénédicte, Protin, Caroline, Abeykoon, Jithma P., Vos, Josephine M. I., Michallet, Anne-Sophie, Rodier, Cyrielle, Dupuis, Jehan, Leprêtre, Stéphane, Merabet, Fatiha, Roussel, Xavier, Zini, Jean-Marc, Regny, Caroline, Patel, Aisha, Morel, Pierre, Roos-Weil, Damien, Treon, Steven P., Dimopoulos, Meletios A., García-Sanz, Ramón, Kapoor, Prashant, Castillo, Jorge J., Delmer, Alain Jacques, Cancer Research UK, Asociación Española Contra el Cáncer, Durot, Eric, Kanagaratnam, Lukshe, Zanwar, Saurabh, Toussaint, Elise, Kastritis, Efstathios, D’Sa, Shirley, Alcoceba, Miguel, Tomowiak, Cécile, Hivert, Bénédicte, Protin, Caroline, Abeykoon, Jithma P., Vos, Josephine M. I., Michallet, Anne-Sophie, Rodier, Cyrielle, Dupuis, Jehan, Leprêtre, Stéphane, Merabet, Fatiha, Roussel, Xavier, Zini, Jean-Marc, Regny, Caroline, Patel, Aisha, Morel, Pierre, Roos-Weil, Damien, Treon, Steven P., Dimopoulos, Meletios A., García-Sanz, Ramón, Kapoor, Prashant, Castillo, Jorge J., and Delmer, Alain Jacques

Abstract

Histologicaltransformation (HT) to diffuse large B-cell lymphoma (DLBCL) is a rare event in Waldenström macroglobulinemia (WM) and is associated with a poor prognosis.1-4 It confers an inferior outcome compared with WM patients without HT.2,3 Most transformed WM patients present with elevated serum lactate dehydrogenase (LDH) levels and extranodal disease.1 Among extranodal sites, the central nervous system (CNS) is one of the most frequently involved sites identified at diagnosis of transformed WM (ranging from 13% to 18%).1,3 However, the prognostic value of CNS involvement is unknown, and the rate of CNS involvement at relapse has not been previously reported in this setting.

Published
2022

12. Transformed Waldenström macroglobulinaemia: clinical presentation and outcome. A multi‐institutional retrospective study of 77 cases from the French Innovative Leukemia Organization (FILO)

Author

Durot, Eric, Tomowiak, Cécile, Michallet, Anne‐Sophie, Dupuis, Jehan, Hivert, Bénédicte, Leprêtre, Stéphane, Toussaint, Elise, Godet, Sophie, Merabet, Fatiha, Van Den Neste, Eric, Ivanoff, Sarah, Roussel, Xavier, Zini, Jean‐Marc, Regny, Caroline, Lemal, Richard, Sutton, Laurent, Perrot, Aurore, Le Dû, Katell, Kanagaratnam, Lukshe, Morel, Pierre, Leblond, Véronique, and Delmer, Alain

Published
2017
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13. High frequency of central nervous system involvement in transformed Waldenström macroglobulinemia

Author

Durot, Eric, Kanagaratnam, Lukshe, Zanwar, Saurabh, Toussaint, Elise, Kastritis, Efstathios, D'Sa, Shirley, Alcoceba, Miguel, Tomowiak, Cécile, Hivert, Bénédicte, Protin, Caroline, Abeykoon, Jithma P., Vos, Josephine M.I., Michallet, Anne-Sophie, Rodier, Cyrielle, Dupuis, Jehan, Leprêtre, Stéphane, Merabet, Fatiha, Roussel, Xavier, Zini, Jean-Marc, Regny, Caroline, Patel, Aisha, Morel, Pierre, Roos-Weil, Damien, Treon, Steven P., Dimopoulos, Meletios A., Garcia-Sanz, Ramon, Kapoor, Prashant, Castillo, Jorge J., and Delmer, Alain Jacques

Published
2022
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15. Blinatumomab for Patients with Richter's Syndrome: A Multicenter Phase 2 Trial from the Filo Group

Author

Guieze, Romain, primary, Ysebaert, Loic, additional, Roos-Weil, Damien, additional, Molina, Lysiane, additional, Fornecker, Luc Mathieu, additional, Aurran, Thérèse, additional, Michallet, Anne-Sophie, additional, Ferrant, Emmanuelle, additional, Clavert, Aline, additional, Saad, Alain, additional, de Guibert, Sophie, additional, Drenou, Bernard, additional, Quittet, Philippe, additional, Hivert, Bénédicte, additional, Laribi, Kamel, additional, Gay, Julie, additional, Broséus, Julien, additional, Rouille, Valérie, additional, Schwartz, David, additional, Pereira, Bruno, additional, Delmer, Alain, additional, and Feugier, Pierre, additional

Published
2021
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16. High Frequency of CNS Involvement in Transformed Waldenström Macroglobulinemia

Author

Durot, Eric, primary, Kanagaratnam, Lukshe, additional, Zanwar, Saurabh, additional, Toussaint, Elise, additional, Kastritis, Efstathios, additional, D'Sa, Shirley, additional, Alcoceba, Miguel, additional, Tomowiak, Cécile, additional, Hivert, Bénédicte, additional, Protin, Caroline, additional, Abeykoon, Jithma P., additional, Vos, Josephine M.I., additional, Michallet, Anne-Sophie, additional, Rodier, Cyrielle, additional, Dupuis, Jehan, additional, Leprêtre, Stéphane, additional, Merabet, Fatiha, additional, Roussel, Xavier, additional, Zini, Jean-Marc, additional, Regny, Caroline, additional, Patel, Aisha S, additional, Morel, Pierre, additional, Roos-Weil, Damien, additional, Treon, Steven P., additional, Dimopoulos, Meletios A., additional, Garcia-Sanz, Ramon, additional, Kapoor, Prashant, additional, Castillo, Jorge J., additional, and Delmer, Alain, additional

Published
2021
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17. Preliminary Results of the Filo Phase 2 Trial for Untreated Fit Patients with Intermediate Risk Chronic Lymphocytic Leukemia Comparing Ibrutinib Plus Venetoclax (IV) Versus FCR

Author

Michallet, Anne-Sophie, primary, Quinquenel, Anne, additional, Letestu, Remi, additional, Le Garff-Tavernier, Magali, additional, Subtil, Fabien, additional, Elsensohn, Mad-Helenie, additional, Aurran, Therese, additional, Laribi, Kamel, additional, Cymbalista, Florence, additional, Levy, Vincent, additional, Simon, Laurence, additional, Roos-Weil, Damien, additional, Leblond, Veronique, additional, Dilhuydy, Marie-Sarah, additional, Tomowiak, Cécile, additional, Dartigeas, Caroline, additional, Guieze, Romain, additional, Tournilhac, Olivier, additional, Ferrant, Emmanuelle, additional, de Guibert, Sophie, additional, Feugier, Pierre, additional, Merabet, Fatiha, additional, Leprêtre, Stéphane, additional, Carassou, Philippe, additional, Gay, Julie, additional, Hivert, Bénédicte, additional, Fornecker, Luc Mathieu, additional, Dupuis, Jehan, additional, Molina, Lysiane, additional, Villemagne, Bruno, additional, Cartron, Guillaume, additional, Drenou, Bernard, additional, Mahé, Béatrice, additional, Benbrahim, Omar, additional, Cahu, Xavier, additional, Portois, Christelle, additional, Ysebaert, Loic, additional, Nguyen-Khac, Florence, additional, Rouille, Valérie, additional, and Delmer, Alain, additional

Published
2021
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18. Clinical and biological characteristics of leukemia cutis in chronic lymphocytic leukemia: A study of the French innovative leukemia organization ( FILO )

Author

Lazarian, Grégory, primary, Munger, Michaël, additional, Quinquenel, Anne, additional, Dilhuydy, Marie‐Sarah, additional, Veronese, Lauren, additional, Luque Paz, Damien, additional, Guièze, Romain, additional, Ledoux‐Pilon, Albane, additional, Paillassa, Jérôme, additional, Merabet, Fatiha, additional, Vial, Jean‐Philippe, additional, Bidet, Audrey, additional, Waultier Rascalou, Agathe, additional, Broseus, Julien, additional, Roos‐Weil, Damien, additional, Lavaud, Anne, additional, Molina, Lysiane, additional, Laribi, Kamel, additional, Hivert, Bénédicte, additional, Friedrich, Chloé, additional, Carpentier, Benjamin, additional, Ysebaert, Loïc, additional, Van Den Neste, Eric, additional, Willems, Lise, additional, Corby, Anne, additional, Poulain, Stéphanie, additional, Eclache, Virginie, additional, Maubec, Eve, additional, Martin, Antoine, additional, Feugier, Pierre, additional, Delmer, Alain, additional, Baran‐Marszak, Fanny, additional, Leprêtre, Stéphane, additional, and Cymbalista, Florence, additional

Published
2021
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19. A prognostic index predicting survival in transformed Waldenstrom macroglobulinemia

Author

Durot, Eric Kanagaratnam, Lukshe Zanwar, Saurabh Kastritis, Efstathios d’Sa, Shirley Garcia-Sanz, Ramon Tomowiak, Cécile Hivert, Bénédicte Toussaint, Elise Protin, Caroline others

Subjects
Health Sciences, Επιστήμες Υγείας
Abstract

Histological transformation into diffuse large B-cell lymphoma is a rare complication in patients with Waldenstrom macroglobulinemia (WM) and is usually associated with a poor prognosis. The objective of this study was to develop and validate a prognostic index for survival of patients with transformed WM. Through this multicenter, international collaborative effort, we developed a scoring system based on data from 133 patients with transformed WM who were evaluated between 1995 and 2016 (training cohort). Univariate and multivariate analyses were used to propose a prognostic index with 2-year survival after transformation as an endpoint. For external validation, a dataset of 67 patients was used to evaluate the performance of the model (validation cohort). By multivariate analysis, three adverse covariates were identified as independent predictors of 2-year survival after transformation: elevated serum lactate dehydrogenase (2 points), platelet count

Published
2021

20. Clinical and biological characteristics of leukemia cutis in chronic lymphocytic leukemia: A study of the French innovative leukemia organization (FILO).

Author

UCL - SSS/DDUV/BCHM - Biochimie-Recherche métabolique, UCL - (SLuc) Service d'hématologie, UCL - (SLuc) Centre du cancer, Lazarian, Grégory, Munger, Michaël, Quinquenel, Anne, Dilhuydy, Marie-Sarah, Veronese, Lauren, Luque Paz, Damien, Guièze, Romain, Ledoux-Pilon, Albane, Paillassa, Jérôme, Merabet, Fatiha, Vial, Jean-Philippe, Bidet, Audrey, Waultier Rascalou, Agathe, Broseus, Julien, Roos-Weil, Damien, Lavaud, Anne, Molina, Lysiane, Laribi, Kamel, Hivert, Bénédicte, Friedrich, Chloé, Carpentier, Benjamin, Ysebaert, Loïc, Van Den Neste, Eric, Willems, Lise, Corby, Anne, Poulain, Stéphanie, Eclache, Virginie, Maubec, Eve, Martin, Antoine, Feugier, Pierre, Delmer, Alain, Baran-Marszak, Fanny, Leprêtre, Stéphane, Cymbalista, Florence, UCL - SSS/DDUV/BCHM - Biochimie-Recherche métabolique, UCL - (SLuc) Service d'hématologie, UCL - (SLuc) Centre du cancer, Lazarian, Grégory, Munger, Michaël, Quinquenel, Anne, Dilhuydy, Marie-Sarah, Veronese, Lauren, Luque Paz, Damien, Guièze, Romain, Ledoux-Pilon, Albane, Paillassa, Jérôme, Merabet, Fatiha, Vial, Jean-Philippe, Bidet, Audrey, Waultier Rascalou, Agathe, Broseus, Julien, Roos-Weil, Damien, Lavaud, Anne, Molina, Lysiane, Laribi, Kamel, Hivert, Bénédicte, Friedrich, Chloé, Carpentier, Benjamin, Ysebaert, Loïc, Van Den Neste, Eric, Willems, Lise, Corby, Anne, Poulain, Stéphanie, Eclache, Virginie, Maubec, Eve, Martin, Antoine, Feugier, Pierre, Delmer, Alain, Baran-Marszak, Fanny, Leprêtre, Stéphane, and Cymbalista, Florence

Abstract

TO THE EDITOR : Patients with chronic lymphocytic leukemia (CLL) exhibit a variety of skin lesions including mostly non-specific cutaneous manifestations (such as cutaneous infections or exaggerated reactions to insect bite) and secondary cutaneous malignancies, as patients are at high risk of developing basal cell carcinoma, squamous cell carcinoma, melanoma, and Merkel cell carcinoma. Specific cutaneous infiltration by neoplastic B lymphocytes with clinically identifiable skin lesions, also called leukemia cutis (LC), is more uncommon and has seldom been reported in chronic lymphocytic leukemia. [...]

Published
2021

21. Minimal Residual Disease-Guided Combination of Ibrutinib and Venetoclax Compared to FCR in Untreated Patients with CLL of Intermediate Risk : Interim Results of MRD Kinetics in the Eradic Trial from the Filo Group

Author

Michallet, Anne-Sophie, Quinquenel, Anne, Letestu, Remi, Magali, Tavernier, Morisset, Stéphane, Aurran, Therese, Laribi, Kamel, Cymbalista, Florence, Levy, Vincent, Simon, Laurence, Roos Weil, Damien, Leblond, Veronique, Dilhuydy, Marie Sarah, Tomowiak, Cecile, Dartigeas, Caroline, Guieze, Romain, Tournilhac, Olivier, Ferrant, Emmanuelle, De Guibert, Sophie, Feugier, Pierre, Merabet, Fatiha, Lepretre, Stéphane, Carassou, Philippe, Gay, Julie, Hivert, Benedicte, Fornecker, Luc Matthieu, Dupuis, Jehan, Molina, Lysiane, Villemagne, Bruno, Cartron, Guillaume, Drenou, Bernard, Mahé, Béatrice, Benbrahim, Omar, Cahu, Xavier, Portois, Christelle, Ysebaert, Loic, Nguyen Khac, Florence, Rouillé, Valerie, and Delmer, Alain Jacques

Published
2023
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22. A prognostic index predicting survival in transformed Waldenström macroglobulinemia

Author

Durot, Eric, primary, Kanagaratnam, Lukshe, additional, Zanwar, Saurabh, additional, Kastritis, Efstathios, additional, D’Sa, Shirley, additional, Garcia-Sanz, Ramon, additional, Tomowiak, Cécile, additional, Hivert, Bénédicte, additional, Toussaint, Elise, additional, Protin, Caroline, additional, Abeykoon, Jithma P., additional, Guerrero-Garcia, Thomas, additional, Itchaki, Gilad, additional, Vos, Josephine M., additional, Michallet, Anne-Sophie, additional, Godet, Sophie, additional, Dupuis, Jehan, additional, Leprêtre, Stéphane, additional, Bomsztyk, Joshua, additional, Morel, Pierre, additional, Leblond, Véronique, additional, Treon, Steven P., additional, Dimopoulos, Meletios A., additional, Kapoor, Prashant, additional, Delmer, Alain, additional, and Castillo, Jorge J., additional

Published
2020
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23. Effects of sphingolipids overload on red blood cell properties in Gaucher disease

Author

Dupuis, Lucie, primary, Chipeaux, Caroline, additional, Bourdelier, Emmanuelle, additional, Martino, Suella, additional, Reihani, Nelly, additional, Belmatoug, Nadia, additional, Billette de Villemeur, Thierry, additional, Hivert, Bénédicte, additional, Moussa, Fathi, additional, Le Van Kim, Caroline, additional, Person, Marine, additional, and Franco, Mélanie, additional

Published
2020
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24. A Cross-Sectional Retrospective Study of Non-Splenectomized and Never-Treated Patients with Type 1 Gaucher Disease

Author

Serratrice, Christine, primary, Stirnemann, Jérôme, additional, Berrahal, Amina, additional, Belmatoug, Nadia, additional, Camou, Fabrice, additional, Caillaud, Catherine, additional, Billette de Villemeur, Thierry, additional, Dalbies, Florence, additional, Cador, Bérengère, additional, Froissart, Roseline, additional, Masseau, Agathe, additional, Brassier, Anaïs, additional, Hivert, Bénédicte, additional, Swiader, Laure, additional, Bertchansky, Ivan, additional, de Moreuil, Claire, additional, Chabrol, Brigitte, additional, Durieu, Isabelle, additional, Leguy Seguin, Vanessa, additional, Astudillo, Leonardo, additional, Humbert, Sébastien, additional, Pichard, Samia, additional, Marcel, Catherine, additional, Hau Rainsard, Isabelle, additional, Bengherbia, Monia, additional, Yousfi, Karima, additional, and Berger, Marc G., additional

Published
2020
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25. Natural history of untreated patients with type 1 Gaucher disease

Author

Serratrice, Christine, primary, Stirnemann, Jérôme, additional, Berrahal, Amina, additional, Belmatoug, Nadia, additional, Camou, Fabrice, additional, de Villemeur, Thierry Billette, additional, Dalbies, Florence, additional, Cador, Bérangère, additional, Masseau, Agathe, additional, Brassier, Anaïs, additional, Hivert, Bénédicte, additional, Swiader, Laure, additional, Bertchansky, Ivan, additional, de Moreuil, Claire, additional, Chabrol, Brigitte, additional, Durieu, Isabelle, additional, Leguy-Seguin, Vanessa, additional, Astudillo, Leonardo, additional, Humbert, Sébastien, additional, Pichard, Samia, additional, Rainsard, Isabelle Hau, additional, Bengherbia, Monia, additional, Yousfi, Karima, additional, and Berger, Marc, additional

Published
2020
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26. Untreated patients with type 1 Gaucher disease: who are they? Resultas from the Gaucher Non-Treated study (GANT study)

Author

Serratrice, Christine, Stirnemann, Jérôme, Berrahal, Amina, Belmatoug, Nadia, Camou, Fabrice, Billette De Villemeur, Thierry, Dalbies, Florence, Cador-Rousseau, Bérangère, Masseau, Agathe, Brassier, Anaïs, Hivert, Bénédicte, Swiader, Laure, Bertchansky, Ivan, De Moreuil, Claire, Chabrol, Brigitte, Durieur, Isabelle, Leguy-Seguin, Vanessa, Astudillo, Léonardo, Humbert, Sébastien, Pichard, Samia, Hau-Rainsard, Isabelle, Bengherbia, Monia, Yousfi, Karima, Berger, Marc G., CHADEYRON, DOMINIQUE, Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias (CHELTER), and Université Clermont Auvergne [2017-2020] (UCA [2017-2020])

Subjects
[SDV.MHEP.HEM] Life Sciences [q-bio]/Human health and pathology/Hematology, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
2019

27. Blinatumomab for Patients with Richter Syndrome: Final Results of the Phase 2 Blinart Trial from the Filo Group

Author

Guieze, Romain, Ysebaert, Loic, Roos-Weil, Damien, Fornecker, Luc-Matthieu, Ferrant, Emmanuelle, Molina, Lysiane, Aurran-Schleinitz, Thérèse, Clavert, Aline, de Guibert, Sophie, Michallet, Anne-Sophie, Saad, Alain, Drenou, Bernard, Quittet, Philippe, Hivert, Benedicte, Laribi, Kamel, Gay, Julie, Broséus, Julien, Rouille, Valérie, Schwartz, David, Pereira, Bruno, Delmer, Alain, and Feugier, Pierre

Published
2022
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29. Transformed Waldenström macroglobulinaemia: clinical presentation and outcome. A multi-institutional retrospective study of 77 cases from the French Innovative Leukemia Organization (FILO).

Author

UCL - SSS/DDUV/BCHM - Biochimie-Recherche métabolique, UCL - (SLuc) Service d'hématologie, Durot, Eric, Tomowiak, Cécile, Michallet, Anne-Sophie, Dupuis, Jehan, Hivert, Bénédicte, Leprêtre, Stéphane, Toussaint, Elise, Godet, Sophie, Merabet, Fatiha, Van Den Neste, Eric, Ivanoff, Sarah, Roussel, Xavier, Zini, Jean-Marc, Regny, Caroline, Lemal, Richard, Sutton, Laurent, Perrot, Aurore, Le Dû, Katell, Kanagaratnam, Lukshe, Morel, Pierre, Leblond, Véronique, Delmer, Alain, UCL - SSS/DDUV/BCHM - Biochimie-Recherche métabolique, UCL - (SLuc) Service d'hématologie, Durot, Eric, Tomowiak, Cécile, Michallet, Anne-Sophie, Dupuis, Jehan, Hivert, Bénédicte, Leprêtre, Stéphane, Toussaint, Elise, Godet, Sophie, Merabet, Fatiha, Van Den Neste, Eric, Ivanoff, Sarah, Roussel, Xavier, Zini, Jean-Marc, Regny, Caroline, Lemal, Richard, Sutton, Laurent, Perrot, Aurore, Le Dû, Katell, Kanagaratnam, Lukshe, Morel, Pierre, Leblond, Véronique, and Delmer, Alain

Abstract

Histological transformation (HT) to diffuse large B-cell lymphoma (DLBCL) is a rare and poorly reported complication of Waldenström macroglobulinaemia (WM). We performed a retrospective study of 77 WM patients with biopsy-proven transformation to DLBCL. The median time from WM diagnosis to HT was 4·6 years and 16 patients (21%) had never been treated for WM. At HT, extranodal sites were observed in 91% of patients with a rather high incidence of central nervous system, cutaneous or testicular involvement. Fluorodeoxyglucose-positron emission tomography was performed in half of the patients and the median maximum standardized uptake value was 15 for transformed disease. More than 80% of cases with available data for assessment by the Hans' algorithm harboured a non-germinal centre B-cell phenotype. First-line treatment for transformation consisted of R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone)-like regimen in 85% of patients. The overall response rate after first-line treatment was 61% and the median overall survival was only 16 months for the entire cohort. Time to transformation above 5 years (P = 0·0004) and elevated LDH (P = 0·02) were associated with worse outcome. Based on these findings, HT should be considered and lead to a biopsy in WM patients presenting with extranodal involvement, elevated LDH and constitutional symptoms. The optimal therapeutic approaches remain to be defined.

Published
2017

31. Bortezomib in Combination with Dexamethasone, Rituximab and Cyclophosphamide (B-DRC) As First - Line Treatment of Waldenstrom's Macroglobulinemia: Results of a Prospectively Randomized Multicenter European Phase II Trial

Author

Buske, Christian, Dimopoulos, Meletios A, Grunenberg, Alexander, Kastritis, Efstathios, Tomowiak, Cecile, Mahé, Béatrice, Troussard, Xavier, Hajek, Roman, Viardot, Andreas, Tournilhac, Olivier, Aurran, Therese, Lepretre, Stephane, Zerazhi, Hacene, Hivert, Benedicte, Leblond, Veronique, de Guibert, Sophie, Brandefors, Lena, Garcia-Sanz, Ramon, Gomes da Silva, Maria, Kimby, Eva, Dreyhaupt, Jens, Muche, Rainer, and Morel, Pierre

Published
2020
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32. Combination of romidepsin with cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated patients with peripheral T-cell lymphoma: a non-randomised, phase 1b/2 study

Author

Dupuis , Jehan, Morschhauser , Franck, Ghesquières , Hervé, Tilly , Hervé, Casasnovas , Olivier, Thieblemont , Catherine, Ribrag , Vincent, Bossard , Céline, Bras , Fabien Le, Bachy , Emmanuel, Hivert , Bénédicte, Nicolas-Virelizier , Emmanuelle, Jardin , Fabrice, Bastie , Jean-Noel, Amorim , Sandy, Lazarovici , Julien, Martin , Antoine, Coiffier , Bertrand, Le Bras , Fabien, Institut de Mathématiques de Toulouse UMR5219 ( IMT ), Centre National de la Recherche Scientifique ( CNRS ) -Institut National des Sciences Appliquées - Toulouse ( INSA Toulouse ), Institut National des Sciences Appliquées ( INSA ) -Institut National des Sciences Appliquées ( INSA ) -PRES Université de Toulouse-Université Paul Sabatier - Toulouse 3 ( UPS ) -Université Toulouse - Jean Jaurès ( UT2J ) -Université Toulouse 1 Capitole ( UT1 ), Service d'hématologie, Hôpital Claude Huriez-Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Groupe d'étude des proliférations lymphoïdes ( GPL ), Université de Rouen Normandie ( UNIROUEN ), Normandie Université ( NU ) -Normandie Université ( NU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ), Service d'Hématologie Clinique (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), Département d'hématologie [Gustave Roussy], Institut Gustave Roussy ( IGR ), Centre Européen de Réalité Virtuelle ( CERV ), École Nationale d'Ingénieurs de Brest ( ENIB ), Centre International de Recherche en Infectiologie ( CIRI ), École normale supérieure - Lyon ( ENS Lyon ) -Université Claude Bernard Lyon 1 ( UCBL ), Université de Lyon-Université de Lyon-Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Centre de recherche en neurobiologie - neurophysiologie de Marseille ( CRN2M ), Aix Marseille Université ( AMU ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Centre National de la Recherche Scientifique ( CNRS ), Laboratoire d'Excellence : Lipoprotéines et Santé : prévention et Traitement des maladies Inflammatoires et du Cancer ( LabEx LipSTIC ), Institut National de la Recherche Agronomique ( INRA ) -Université Montpellier 2 - Sciences et Techniques ( UM2 ) -Université Paris-Sud - Paris 11 ( UP11 ) -École pratique des hautes études ( EPHE ) -Institut Gustave Roussy ( IGR ) -Centre Hospitalier Régional Universitaire de Nancy ( CHRU Nancy ) -Université de Bourgogne ( UB ) -Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ) -Centre Régional de Lutte contre le cancer - Centre Georges-François Leclerc ( CRLCC - CGFL ) -Institut National de la Santé et de la Recherche Médicale ( INSERM ) -Fédération Francophone de la Cancérologie Digestive, FFCD-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Etablissement français du sang [Bourgogne-France-Comté] ( EFS [Bourgogne-France-Comté] ) -Centre National de la Recherche Scientifique ( CNRS ) -Centre Hospitalier Régional Universitaire [Besançon] ( CHRU Besançon ) -Université de Franche-Comté ( UFC ), Laboratoire de Parasitologie-Mycologie [Paris], Assistance publique - Hôpitaux de Paris (AP-HP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Université Paris Diderot - Paris 7 ( UPD7 ), Centre de Recherche en Cancérologie de Lyon ( CRCL ), Centre Léon Bérard [Lyon]-Université Claude Bernard Lyon 1 ( UCBL ), Service d’Hématologie [Centre Hospitalier Lyon Sud - HCL], Centre Hospitalier Lyon Sud [CHU - HCL] ( CHLS ), Hospices Civils de Lyon ( HCL ) -Hospices Civils de Lyon ( HCL ), CHU Henri Mondor, Institut de Mathématiques de Toulouse UMR5219 (IMT), Université Toulouse 1 Capitole (UT1)-Université Toulouse - Jean Jaurès (UT2J)-Université Toulouse III - Paul Sabatier (UPS), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-PRES Université de Toulouse-Institut National des Sciences Appliquées - Toulouse (INSA Toulouse), Institut National des Sciences Appliquées (INSA)-Institut National des Sciences Appliquées (INSA)-Centre National de la Recherche Scientifique (CNRS), Hôpital Claude Huriez-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Groupe d'étude des proliférations lymphoïdes (GPL), Université de Rouen Normandie (UNIROUEN), Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Institut Gustave Roussy (IGR), Centre Européen de Réalité Virtuelle (CERV), École Nationale d'Ingénieurs de Brest (ENIB), Centre International de Recherche en Infectiologie - UMR (CIRI), Institut National de la Santé et de la Recherche Médicale (INSERM)-École normale supérieure - Lyon (ENS Lyon)-Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre National de la Recherche Scientifique (CNRS), Centre de recherche en neurobiologie - neurophysiologie de Marseille (CRN2M), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Laboratoire d'Excellence : Lipoprotéines et Santé : prévention et Traitement des maladies Inflammatoires et du Cancer (LabEx LipSTIC), Institut National de la Recherche Agronomique (INRA)-Université Montpellier 2 - Sciences et Techniques (UM2)-Université Paris-Sud - Paris 11 (UP11)-École pratique des hautes études (EPHE)-Institut Gustave Roussy (IGR)-Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy)-Université de Bourgogne (UB)-Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon)-Centre Régional de Lutte contre le cancer - Centre Georges-François Leclerc (CRLCC - CGFL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Fédération Francophone de la Cancérologie Digestive, FFCD-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Etablissement français du sang [Bourgogne-France-Comté] (EFS [Bourgogne-France-Comté])-Centre National de la Recherche Scientifique (CNRS)-Centre Hospitalier Régional Universitaire [Besançon] (CHRU Besançon)-Université de Franche-Comté (UFC), Assistance publique - Hôpitaux de Paris (AP-HP) (APHP)-Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal [Paris], Université Paris Diderot - Paris 7 (UPD7), Centre de Recherche en Cancérologie de Lyon (CRCL), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Centre Léon Bérard [Lyon]-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre Hospitalier Lyon Sud [CHU - HCL] (CHLS), and Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL)

Subjects
[SDV.CAN]Life Sciences [q-bio]/Cancer, [ SDV.CAN ] Life Sciences [q-bio]/Cancer
Abstract

International audience; Romidepsin is a histone deacetylase inhibitor approved in the USA for patients with recurrent or refractory peripheral T-cell lymphoma and has shown activity in this setting with mainly haematological and gastrointestinal toxicity. Although it has limited efficacy, cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy is widely used for treatment of de-novo peripheral T-cell lymphoma. We aimed to assess the safety, tolerability, and activity of romidepsin combined with CHOP in patients with previously untreated disease.; We enrolled patients aged 18-80 years with histologically proven, previously untreated, peripheral T-cell lymphoma (Eastern Cooperative Oncology Group performance status ≤2) into a dose-escalation (phase 1b) and expansion (phase 2) study at nine Lymphoma Study Association centres in France. In the dose-escalation phase, we allocated consecutive blocks of three participants to receive eight 3 week cycles of CHOP (intravenous cyclophosphamide 750 mg/m(2), doxorubicin 50 mg/m(2), and vincristine 1.4 mg/m(2) [maximum 2 mg] on day 1 and oral prednisone 40 mg/m(2) on days 1-5) in association with varying doses of romidepsin. The starting dose was 10 mg/m(2) intravenously on days 1 and 8 of each cycle, and we used a 3 + 3 design. We assessed dose-limiting toxicities only during the first two cycles. The primary endpoint was to determine the recommended dose for the combination. For the phase 2 study, we aimed to increase the cohort of patients receiving the recommended dose to a total of 25 patients. Patients were assessed for safety outcomes at least twice per cycle according to the Common Terminology Criteria for Adverse Events, version 4.0. Safety analyses included all patients who received at least one dose of romidepsin and CHOP. This trial is registered at the European Clinical Trials Database (EudraCT), number 2010-020962-91 and ClinicalTrials.gov, number NCT01280526.; Between Jan 13, 2011, and May 21, 2013, we enrolled 37 patients (18 treated in phase 1b and 19 patients in phase 2). Three of six patients initially treated at 10 mg/m(2) had a dose-limiting toxicity. The dose-escalation committee decided to modify the study protocol to redefine dose-limiting toxicities with regard to haematological toxicity. Three patients were treated with 8 mg/m(2) of romidepsin, an additional three at 10 mg/m(2) (one dose-limiting toxicity), and six patients at 12 mg/m(2) (three dose-limiting toxicities). We chose romidepsin 12 mg/m(2) as the recommended dose for phase 2. Of the 37 patients treated, three had early cardiac events (two myocardial infarctions and one acute cardiac failure). No deaths were attributable to toxicity. 25 (68%) of 37 patients had at least one serious adverse event. Overall, the most frequent serious adverse events were febrile neutropenia (five [14%] of 37 patients), physical health deterioration (five [14%]), lung infection (four [11%]), and vomiting (three [8%]). 33 (89%) of patients had grade 3-4 neutropenia, and 29 (78%) had grade 3-4 thrombocytopenia.; Romidepsin can be combined with CHOP but this combination should now be tested in comparison to CHOP alone in a randomised trial.; Celgene.

Published
2015

33. A Low Effective Dose of Interleukin-7 is Sufficient to Maintain Cord Blood T Cells Alive without Potentiating Allo-Immune Responses

Author

Pascal, Laurent, Hivert, Bénédicte, Trauet, Jacques, Deberranger, Eva, Dessaint, Jean-Paul, Yakoub-Agha, Ibrahim, and Labalette, Myriam

Abstract

Slow reconstitution of T cell immunity remains a critical issue after umbilical cord blood (CB) transplantation. Although this may be a consequence of the low cell dose, it may also reflect the propensity of naïve T cells, which predominate in CB, to undergo apoptotic cell death. Exogenous interleukin 7 (IL-7) can prevent apoptosis of naïve T cells, but at high concentrations, IL-7 may also expand alloreactive T cells, thereby aggravating the risk of graft-versus-host disease. We evaluated the survival of CB T cells from 34 healthy full-term pregnancies, and we found wide interdonor variation, from 17.4% to 79.7%, of CB T cells that were still alive after being rested for 4 days in culture medium without cytokine supplementation. The viability of CB T cells was negatively correlated to infant birth weight (Spearman's ρ = .376; P = .031) and positively correlated to venous CB pH (ρ = .397; P = .027); both associations were confirmed by multivariate analysis (P = .023 and P = .005, respectively). A low supplemental concentration (100 pg/mL) of recombinant human IL-7 was sufficient to maintain the viability of cryopreserved/thawed CB T cells, with most (>80%) cells remaining in a quiescent state and without significant changes in their CD4/CD8 ratio and the proportion of CD4+CD31+PTK7+recent thymic emigrants. IL-7 at 100 pg/mL did not lead to any significant enhancement of the alloreactive response of CB T cells, as evaluated by proliferation rates (thymidine incorporation and carboxyfluorescein diacetate succinimidyl ester dilution) and interferon-gamma production (ELISPOT). This effective concentration of IL-7 is far lower than that obtained in vivo after pharmacological administration of the cytokine. This study suggests that administration of lower doses of recombinant human IL-7 than used in previous clinical trials may be sufficient to sustain the viability of infused CB T cells and, thus, help to accelerate naïve T cell reconstitution without potentiating their alloreactivity.

Published
2024
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34. Outcome of Patients Receiving Venetoclax for Chronic Lymphocytic Leukemia (CLL) in Real-Life Clinical Practice: Results of the French ATU Program on Behalf of the Filo Group

Author

Bouclet, Florian, Calleja, Anne, Dilhuydy, Marie-Sarah, Amorim, Sandy, Cymbalista, Florence, Herbaux, Charles, de Guibert, Sophie, Roos-Weil, Damien, Hivert, Benedicte, Aurran, Thérèse, Dupuis, Jehan, Blouet, Anaise, Tchernonog, Emmanuelle, Laribi, Kamel, Dmytruk, Natalia, Morel, Pierre, Michallet, Anne-Sophie, Dartigeas, Caroline, Farnault, Laure, Lavaud, Anne, Plantier, Isabelle, Bay, Jacques-Olivier, Tournilhac, Olivier, Delmer, Alain Jacques, Feugier, Pierre, Ysebaert, Loic, and Guieze, Romain

Published
2018
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35. Safety Profile of Bortezomib Impacts Survival in Light Chain Amyloidosis

Author

Van de Wyngaert, Zoé, primary, Vanoutryve, Greg, additional, Fouquet, Guillemette, additional, Guidez, Stéphanie, additional, Herbaux, Charles, additional, Demarquette, Helene, additional, Renaud, Loic, additional, Terriou, Louis, additional, Noel, Marie Pierre, additional, Petillon, Marie Odile, additional, Hivert, Bénédicte, additional, Wemeau, Matthieu, additional, Launay, David, additional, Lamblin, Nicolas, additional, Hachulla, Eric, additional, Facon, Thierry, additional, and Leleu, Xavier, additional

Published
2014
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36. A prognostic index predicting survival in transformed Waldenström macroglobulinemia.

Author

Durot E, Kanagaratnam L, Zanwar S, Kastritis E, D'Sa S, Garcia-Sanz R, Tomowiak C, Hivert B, Toussaint E, Protin C, Abeykoon JP, Guerrero-Garcia T, Itchaki G, Vos JM, Michallet AS, Godet S, Dupuis J, Leprêtre S, Bomsztyk J, Morel P, Leblond V, Treon SP, Dimopoulos MA, Kapoor P, Delmer A, and Castillo JJ

Subjects
Humans, Prognosis, Proportional Hazards Models, Survival Rate, Lymphoma, Large B-Cell, Diffuse, Waldenstrom Macroglobulinemia diagnosis
Abstract

Histological transformation into diffuse large B-cell lymphoma is a rare complication in patients with Waldenström macroglobulinemia (WM) usually associated with a poor prognosis. The objective of this study was to develop and validate a prognostic index for survival in transformed WM patients. Through this multicenter, international collaborative effort, we developed a scoring system based on data from 133 patients with transformed WM who were evaluated between 1995 and 2016 (training cohort). Univariate and multivariate analyses were used to propose a prognostic index with 2-year survival after transformation as an end-point. For external validation, a data set of 67 patients was used to evaluate the performance of the model (validation cohort). By multivariate analysis, three adverse covariates were identified as independent predictors of 2-year survival after transformation: elevated serum LDH (2 points), platelet count < 100 x 109/L (1 point) and any previous treatment for WM (1 point). Three risk groups were defined: low-risk (0-1 point, 24% of patients), intermediate-risk (2-3 points, 59%, hazard ratio (HR) = 3.4) and high-risk (4 points, 17%, HR = 7.5). Two-year survival rates were 81%, 47%, and 21%, respectively (P < 0.0001). This model appeared to be a better discriminant than the International Prognostic Index (IPI) and the revised IPI (R-IPI). We validated this model in an independent cohort. This easy-to-compute scoring index is a robust tool that may allow identification of groups of transformed WM patients with different outcomes and could be used for improving the development of risk-adapted treatment strategies.

Published
2021
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37. Combination of romidepsin with cyclophosphamide, doxorubicin, vincristine, and prednisone in previously untreated patients with peripheral T-cell lymphoma: a non-randomised, phase 1b/2 study.

Author

Dupuis J, Morschhauser F, Ghesquières H, Tilly H, Casasnovas O, Thieblemont C, Ribrag V, Bossard C, Le Bras F, Bachy E, Hivert B, Nicolas-Virelizier E, Jardin F, Bastie JN, Amorim S, Lazarovici J, Martin A, and Coiffier B

Subjects
Adult, Aged, Cyclophosphamide therapeutic use, Doxorubicin therapeutic use, Drug Administration Schedule, Female, France, Humans, Male, Middle Aged, Prednisone therapeutic use, Treatment Outcome, Vincristine therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Depsipeptides therapeutic use, Lymphoma, T-Cell, Peripheral drug therapy
Abstract

Background: Romidepsin is a histone deacetylase inhibitor approved in the USA for patients with recurrent or refractory peripheral T-cell lymphoma and has shown activity in this setting with mainly haematological and gastrointestinal toxicity. Although it has limited efficacy, cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy is widely used for treatment of de-novo peripheral T-cell lymphoma. We aimed to assess the safety, tolerability, and activity of romidepsin combined with CHOP in patients with previously untreated disease., Methods: We enrolled patients aged 18-80 years with histologically proven, previously untreated, peripheral T-cell lymphoma (Eastern Cooperative Oncology Group performance status ≤2) into a dose-escalation (phase 1b) and expansion (phase 2) study at nine Lymphoma Study Association centres in France. In the dose-escalation phase, we allocated consecutive blocks of three participants to receive eight 3 week cycles of CHOP (intravenous cyclophosphamide 750 mg/m(2), doxorubicin 50 mg/m(2), and vincristine 1.4 mg/m(2) [maximum 2 mg] on day 1 and oral prednisone 40 mg/m(2) on days 1-5) in association with varying doses of romidepsin. The starting dose was 10 mg/m(2) intravenously on days 1 and 8 of each cycle, and we used a 3 + 3 design. We assessed dose-limiting toxicities only during the first two cycles. The primary endpoint was to determine the recommended dose for the combination. For the phase 2 study, we aimed to increase the cohort of patients receiving the recommended dose to a total of 25 patients. Patients were assessed for safety outcomes at least twice per cycle according to the Common Terminology Criteria for Adverse Events, version 4.0. Safety analyses included all patients who received at least one dose of romidepsin and CHOP. This trial is registered at the European Clinical Trials Database (EudraCT), number 2010-020962-91 and ClinicalTrials.gov, number NCT01280526., Findings: Between Jan 13, 2011, and May 21, 2013, we enrolled 37 patients (18 treated in phase 1b and 19 patients in phase 2). Three of six patients initially treated at 10 mg/m(2) had a dose-limiting toxicity. The dose-escalation committee decided to modify the study protocol to redefine dose-limiting toxicities with regard to haematological toxicity. Three patients were treated with 8 mg/m(2) of romidepsin, an additional three at 10 mg/m(2) (one dose-limiting toxicity), and six patients at 12 mg/m(2) (three dose-limiting toxicities). We chose romidepsin 12 mg/m(2) as the recommended dose for phase 2. Of the 37 patients treated, three had early cardiac events (two myocardial infarctions and one acute cardiac failure). No deaths were attributable to toxicity. 25 (68%) of 37 patients had at least one serious adverse event. Overall, the most frequent serious adverse events were febrile neutropenia (five [14%] of 37 patients), physical health deterioration (five [14%]), lung infection (four [11%]), and vomiting (three [8%]). 33 (89%) of patients had grade 3-4 neutropenia, and 29 (78%) had grade 3-4 thrombocytopenia., Interpretation: Romidepsin can be combined with CHOP but this combination should now be tested in comparison to CHOP alone in a randomised trial., Funding: Celgene., (Copyright © 2015 Elsevier Ltd. All rights reserved.)

Published
2015
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