10 results on '"Ketterer, Nicolas"'
Search Results
2. Superiority of the triple combination of bortezomib-thalidomide-dexamethasone over the dual combination of thalidomide-dexamethasone in patients with multiple myeloma progressing or relapsing after autologous transplantation
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UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Garderet, Laurent, Iacobelli, Simona, Moreau, Philippe, Dib, Mamoun, Lafon, Ingrid, Niederwieser, Dietger, Masszi, Tamas, Fontan, Jean, Michallet, Mauricette, Gratwohl, Alois, Milone, Giuseppe, Doyen, Chantal, Pegourie, Brigitte, Hajek, Roman, Casassus, Philippe, Kolb, Brigitte, Chaleteix, Carine, Hertenstein, Bernd, Onida, Francesco, Ludwig, Heinz, Ketterer, Nicolas, Koenecke, Christian, van Os, Marleen, Mohty, Mohamad, Cakana, Andrew, Gorin, Norbert Claude, de Witte, Theo, Harousseau, Jean Luc, Morris, Curly, Gahrton, Gösta, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Garderet, Laurent, Iacobelli, Simona, Moreau, Philippe, Dib, Mamoun, Lafon, Ingrid, Niederwieser, Dietger, Masszi, Tamas, Fontan, Jean, Michallet, Mauricette, Gratwohl, Alois, Milone, Giuseppe, Doyen, Chantal, Pegourie, Brigitte, Hajek, Roman, Casassus, Philippe, Kolb, Brigitte, Chaleteix, Carine, Hertenstein, Bernd, Onida, Francesco, Ludwig, Heinz, Ketterer, Nicolas, Koenecke, Christian, van Os, Marleen, Mohty, Mohamad, Cakana, Andrew, Gorin, Norbert Claude, de Witte, Theo, Harousseau, Jean Luc, Morris, Curly, and Gahrton, Gösta
- Abstract
PURPOSE: This prospective multicenter phase III study compared the efficacy and safety of a triple combination (bortezomib-thalidomide-dexamethasone [VTD]) versus a dual combination (thalidomide-dexamethasone [TD]) in patients with multiple myeloma (MM) progressing or relapsing after autologous stem-cell transplantation (ASCT). PATIENTS AND METHODS: Overall, 269 patients were randomly assigned to receive bortezomib (1.3 mg/m(2) intravenous bolus) or no bortezomib for 1 year, in combination with thalidomide (200 mg per day orally) and dexamethasone (40 mg orally once a day on 4 days once every 3 weeks). Bortezomib was administered on days 1, 4, 8, and 11 with a 10-day rest period (day 12 to day 21) for eight cycles (6 months), and then on days 1, 8, 15, and 22 with a 20-day rest period (day 23 to day 42) for four cycles (6 months). RESULTS: Median time to progression (primary end point) was significantly longer with VTD than TD (19.5 v 13.8 months; hazard ratio, 0.59; 95% CI, 0.44 to 0.80; P = .001), the complete response plus near-complete response rate was higher (45% v 25%; P = .001), and the median duration of response was longer (17.2 v 13.4 months; P = .03). The 24-month survival rate was in favor of VTD (71% v 65%; P = .093). Grade 3 peripheral neuropathy was more frequent with VTD (29% v 12%; P = .001) as were the rates of grades 3 and 4 infection and thrombocytopenia. CONCLUSION: VTD was more effective than TD in the treatment of patients with MM with progressive or relapsing disease post-ASCT but was associated with a higher incidence of grade 3 neurotoxicity.
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- 2012
3. Rituximab maintenance therapy after autologous stem-cell transplantation in patients with relapsed CD20+ diffuse large B-cell lymphoma: Final analysis of the collaborative trial in relapsed aggressive lymphoma
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UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Gisselbrecht, Christian, Schmitz, Norbert, Mounier, Nicolas, Gill, Devinder S., Linch, David C., Trneny, Marek, Bosly, André, Milpied, Noel J., Radford, John, Ketterer, Nicolas, Shpilberg, Ofer, Duḧrsen, Ulrich, Hagberg, Hans, Ma, D.D., Viardot, Andreas, Lowenthal, Ray, Brière, Josette, Salles, Gilles, Moskowitz, Craig H., Glass, Bertram, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'hématologie, Gisselbrecht, Christian, Schmitz, Norbert, Mounier, Nicolas, Gill, Devinder S., Linch, David C., Trneny, Marek, Bosly, André, Milpied, Noel J., Radford, John, Ketterer, Nicolas, Shpilberg, Ofer, Duḧrsen, Ulrich, Hagberg, Hans, Ma, D.D., Viardot, Andreas, Lowenthal, Ray, Brière, Josette, Salles, Gilles, Moskowitz, Craig H., and Glass, Bertram
- Abstract
Purpose: The standard treatment for relapsed diffuse large B-cell lymphoma (DLBCL) is salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation (ASCT). The impact of maintenance rituximab after ASCT is not known. Patients and Methods: In total, 477 patients with CD20 + DLBCL who were in their first relapse or refractory to initial therapy were randomly assigned to one of two salvage regimens. After three cycles of salvage chemotherapy, the responding patients received high-dose chemotherapy followed by ASCT. Then, 242 patients were randomly assigned to either rituximab every 2 months for 1 year or observation. Results: After ASCT, 122 patients received rituximab, and 120 patients were observed only. The median follow-up time was 44 months. The 4-year event-free survival (EFS) rates after ASCT were 52% and 53% for the rituximab and observation groups, respectively (P = .7). Treatment with rituximab was associated with a 15% attributable risk of serious adverse events after day 100, with more deaths (six deaths v three deaths in the observation arm). Several factors affected EFS after ASCT (P < .05), including relapsed disease within 12 months (EFS: 46% v 56% for relapsed disease after 12 months), secondary age-adjusted International Prognostic Index (saaIPI) more than 1 (EFS: 37% v 61% for saaIPI < 1), and prior treatment with rituximab (EFS: 47% v 59% for no prior rituximab). A significant difference in EFS between women (63%) and men (46%) was also observed in the rituximab group. In the Cox model for maintenance, the saaIPI was a significant prognostic factor (P < .001), as was male sex (P = .01). Conclusion: In relapsed DLBCL, we observed no difference between the control group and the rituximab maintenance group and do not recommend rituximab after ASCT. © 2012 by American Society of Clinical Oncology.
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- 2012
4. Event-Free Survival at 24 Months Is a Robust End Point for Disease-Related Outcome in Diffuse Large B-Cell Lymphoma Treated With Immunochemotherapy.
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Maurer, Matthew J., Ghesquières, Hervé, Jais, Jean-Philippe, Witzig, Thomas E., Haioun, Corinne, Thompson, Carrie A., Delarue, Richard, Micallef, Ivana N., Peyrade, Frèdèric, Macon, William R., Jo Molina, Thierry, Ketterer, Nicolas, Syrbu, Sergei I., Fitoussi, Olivier, Kurtin, Paul J., Allmer, Cristine, Nicolas-Virelizier, Emmanuelle, Slager, Susan L., Habermann, Thomas M., and Link, Brian K.
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- 2014
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5. Rituximab Maintenance Therapy After Autologous Stem-Cell Transplantation in Patients With Relapsed CD20+ Diffuse Large B-Cell Lymphoma: Final Analysis of the Collaborative Trial in Relapsed Aggressive Lymphoma.
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Gisselbrecht, Christian, Schmitz, Norbert, Mounier, Nicolas, Gill, Devinder Singh, Linch, David C., Trneny, Marek, Bosly, Andre, Milpied, Noel J., Radford, John, Ketterer, Nicolas, Shpilberg, Ofer, Duhrsen, Ulrich, Hagberg, Hans, Ma, David D., Viardot, Andreas, Lowenthal, Ray, Brière, Josette, Salles, Gilles, Moskowitz, Craig H., and Glass, Bertram
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- 2012
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6. Superiority of the triple combination of bortezomib-thalidomide-dexamethasone over the dual combination of thalidomide-dexamethasone in patients with multiple myeloma progressing or relapsing after autologous transplantation: the MMVAR/IFM 2005-04 Randomized Phase III Trial from the Chronic Leukemia Working Party of the European Group for Blood and Marrow Transplantation.
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Garderet L, Iacobelli S, Moreau P, Dib M, Lafon I, Niederwieser D, Masszi T, Fontan J, Michallet M, Gratwohl A, Milone G, Doyen C, Pegourie B, Hajek R, Casassus P, Kolb B, Chaleteix C, Hertenstein B, Onida F, Ludwig H, Ketterer N, Koenecke C, van Os M, Mohty M, Cakana A, Gorin NC, de Witte T, Harousseau JL, Morris C, and Gahrton G
- Subjects
- Adult, Aged, Boronic Acids administration & dosage, Bortezomib, Dexamethasone administration & dosage, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Male, Middle Aged, Multiple Myeloma mortality, Multiple Myeloma pathology, Pyrazines administration & dosage, Recurrence, Thalidomide administration & dosage, Transplantation, Autologous, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy, Stem Cell Transplantation
- Abstract
Purpose: This prospective multicenter phase III study compared the efficacy and safety of a triple combination (bortezomib-thalidomide-dexamethasone [VTD]) versus a dual combination (thalidomide-dexamethasone [TD]) in patients with multiple myeloma (MM) progressing or relapsing after autologous stem-cell transplantation (ASCT)., Patients and Methods: Overall, 269 patients were randomly assigned to receive bortezomib (1.3 mg/m(2) intravenous bolus) or no bortezomib for 1 year, in combination with thalidomide (200 mg per day orally) and dexamethasone (40 mg orally once a day on 4 days once every 3 weeks). Bortezomib was administered on days 1, 4, 8, and 11 with a 10-day rest period (day 12 to day 21) for eight cycles (6 months), and then on days 1, 8, 15, and 22 with a 20-day rest period (day 23 to day 42) for four cycles (6 months)., Results: Median time to progression (primary end point) was significantly longer with VTD than TD (19.5 v13.8 months; hazard ratio, 0.59; 95% CI, 0.44 to 0.80; P = .001), the complete response plus near-complete response rate was higher (45% v 21%; P 0.001), and the median duration of response was longer (17.9 v 13.4 months; P.04) [corrected].The 24-month survival rate was in favor of VTD (71% v 65%; P = .093). Grade 3 peripheral neuropathy was more frequent with VTD (29% v 12%; P = .001) as were the rates of grades 3 and 4 infection and thrombocytopenia., Conclusion: VTD was more effective than TD in the treatment of patients with MM with progressive or relapsing disease post-ASCT but was associated with a higher incidence of grade 3 neurotoxicity.
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- 2012
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7. Salvage regimens with autologous transplantation for relapsed large B-cell lymphoma in the rituximab era.
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Gisselbrecht C, Glass B, Mounier N, Singh Gill D, Linch DC, Trneny M, Bosly A, Ketterer N, Shpilberg O, Hagberg H, Ma D, Brière J, Moskowitz CH, and Schmitz N
- Subjects
- Adult, Aged, Antibodies, Monoclonal, Murine-Derived, Antigens, CD20 analysis, Antineoplastic Combined Chemotherapy Protocols adverse effects, Australia, Carboplatin administration & dosage, Chemotherapy, Adjuvant, Cytarabine administration & dosage, Dexamethasone administration & dosage, Disease-Free Survival, Etoposide administration & dosage, Europe, Female, Humans, Ifosfamide administration & dosage, Israel, Kaplan-Meier Estimate, Lymphoma, Large B-Cell, Diffuse immunology, Lymphoma, Large B-Cell, Diffuse mortality, Lymphoma, Large B-Cell, Diffuse pathology, Male, Middle Aged, Neoplasm Staging, New York City, Proportional Hazards Models, Recurrence, Risk Assessment, Risk Factors, Rituximab, Time Factors, Transplantation, Autologous, Treatment Outcome, Young Adult, Antibodies, Monoclonal administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Lymphoma, Large B-Cell, Diffuse drug therapy, Lymphoma, Large B-Cell, Diffuse surgery, Salvage Therapy, Stem Cell Transplantation
- Abstract
Purpose: Salvage chemotherapy followed by high-dose therapy and autologous stem-cell transplantation (ASCT) is the standard treatment for relapsed diffuse large B-cell lymphoma (DLBCL). Salvage regimens have never been compared; their efficacy in the rituximab era is unknown., Patients and Methods: Patients with CD20(+) DLBCL in first relapse or who were refractory after first-line therapy were randomly assigned to either rituximab, ifosfamide, etoposide, and carboplatin (R-ICE) or rituximab, dexamethasone, high-dose cytarabine, and cisplatin (R-DHAP). Responding patients received high-dose chemotherapy and ASCT., Results: The median age of the 396 patients enrolled (R-ICE, n = 202; R-DHAP, n = 194) was 55 years. Similar response rates were observed after three cycles of R-ICE (63.5%; 95% CI, 56% to 70%) and R-DHAP (62.8%; 95 CI, 55% to 69%). Factors affecting response rates (P < .001) were refractory disease/relapse less than versus more than 12 months after diagnosis (46% v 88%, respectively), International Prognostic Index (IPI) of more than 1 versus 0 to 1 (52% v 71%, respectively), and prior rituximab treatment versus no prior rituximab (51% v 83%, respectively). There was no significant difference between R-ICE and R-DHAP for 3-year event-free survival (EFS) or overall survival. Three-year EFS was affected by prior rituximab treatment versus no rituximab (21% v 47%, respectively), relapse less than versus more than 12 months after diagnosis (20% v 45%, respectively), and IPI of 2 to 3 versus 0 to 1 (18% v 40%, respectively). In the Cox model, these parameters were significant (P < .001)., Conclusion: In patients who experience relapse more than 12 months after diagnosis, prior rituximab treatment does not affect EFS. Patients with early relapses after rituximab-containing first-line therapy have a poor prognosis, with no difference between the effects of R-ICE and R-DHAP.
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- 2010
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8. Safety, pharmacokinetics, and preliminary clinical activity of inotuzumab ozogamicin, a novel immunoconjugate for the treatment of B-cell non-Hodgkin's lymphoma: results of a phase I study.
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Advani A, Coiffier B, Czuczman MS, Dreyling M, Foran J, Gine E, Gisselbrecht C, Ketterer N, Nasta S, Rohatiner A, Schmidt-Wolf IG, Schuler M, Sierra J, Smith MR, Verhoef G, Winter JN, Boni J, Vandendries E, Shapiro M, and Fayad L
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- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal administration & dosage, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal pharmacokinetics, Antibodies, Monoclonal, Humanized, Antineoplastic Agents administration & dosage, Antineoplastic Agents adverse effects, Antineoplastic Agents pharmacokinetics, Disease-Free Survival, Europe, Female, Humans, Immunotoxins administration & dosage, Immunotoxins adverse effects, Immunotoxins pharmacokinetics, Infusions, Intravenous, Inotuzumab Ozogamicin, Kaplan-Meier Estimate, Lymphoma, Follicular immunology, Lymphoma, Follicular mortality, Lymphoma, Large B-Cell, Diffuse immunology, Lymphoma, Large B-Cell, Diffuse mortality, Male, Maximum Tolerated Dose, Middle Aged, Pilot Projects, Sialic Acid Binding Ig-like Lectin 2 immunology, Time Factors, Treatment Outcome, Antibodies, Monoclonal therapeutic use, Antineoplastic Agents therapeutic use, Immunotoxins therapeutic use, Lymphoma, Follicular drug therapy, Lymphoma, Large B-Cell, Diffuse drug therapy
- Abstract
PURPOSE Inotuzumab ozogamicin (CMC-544) is an antibody-targeted chemotherapy agent composed of a humanized anti-CD22 antibody conjugated to calicheamicin, a potent cytotoxic agent. This was a phase I study to determine the maximum-tolerated dose (MTD), safety, and preliminary efficacy of inotuzumab ozogamicin in an expanded MTD cohort of patients with relapsed or refractory CD22(+) B-cell non-Hodgkin's lymphoma (NHL). PATIENTS AND METHODS Inotuzumab ozogamicin was administered intravenously as a single agent once every 3 or 4 weeks at doses ranging from 0.4 to 2.4 mg/m(2). Outcomes included MTD, safety, pharmacokinetics, response, progression-free survival (PFS), and overall survival. Results Seventy-nine patients were enrolled. The MTD was determined to be 1.8 mg/m(2). Common adverse events at the MTD were thrombocytopenia (90%), asthenia (67%), and nausea and neutropenia (51% each). The objective response rate at the end of treatment was 39% for the 79 enrolled patients, 68% for all patients with follicular NHL treated at the MTD, and 15% for all patients with diffuse large B-cell lymphoma treated at the MTD. Median PFS was 317 days (approximately 10.4 months) and 49 days for patients with follicular NHL and diffuse large B-cell lymphoma, respectively. CONCLUSION Inotuzumab ozogamicin has demonstrated efficacy against CD22(+) B-cell NHL, with reversible thrombocytopenia as the main toxicity.
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- 2010
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9. Achievement of at least very good partial response is a simple and robust prognostic factor in patients with multiple myeloma treated with high-dose therapy: long-term analysis of the IFM 99-02 and 99-04 Trials.
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Harousseau JL, Avet-Loiseau H, Attal M, Charbonnel C, Garban F, Hulin C, Michallet M, Facon T, Garderet L, Marit G, Ketterer N, Lamy T, Voillat L, Guilhot F, Doyen C, Mathiot C, and Moreau P
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- Combined Modality Therapy, Dexamethasone administration & dosage, Disease-Free Survival, Doxorubicin administration & dosage, Humans, Middle Aged, Multiple Myeloma drug therapy, Multiple Myeloma mortality, Prognosis, Remission Induction, Survival Rate, Transplantation, Autologous, Vincristine administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Hematopoietic Stem Cell Transplantation, Multiple Myeloma therapy
- Abstract
Purpose: The prognostic impact of complete response (CR) achievement in multiple myeloma (MM) has been shown mostly in the context of autologous stem-cell transplantation. Other levels of response have been defined because, even with high-dose therapy, CR is a relatively rare event. The purpose of this study was to analyze the prognostic impact of very good partial response (VGPR) in patients treated with high-dose therapy., Patients and Methods: All patients were included in the Intergroupe Francophone du Myelome 99-02 and 99-04 trials and treated with vincristine, doxorubicin, and dexamethasone (VAD) induction therapy followed by double autologous stem-cell transplantation (ASCT). Best post-ASCT response assessment was available for 802 patients., Results: With a median follow-up of 67 months, median event-free survival (EFS) and 5-year EFS were 42 months and 34%, respectively, for 405 patients who achieved at least VGPR after ASCT versus 32 months and 26% in 288 patients who achieved only partial remission (P = .005). Five-year overall survival (OS) was significantly superior in patients achieving at least VGPR (74% v 61% P = .0017). In multivariate analysis, achievement of less than VGPR was an independent factor predicting shorter EFS and OS. Response to VAD had no impact on EFS and OS. The impact of VGPR achievement on EFS and OS was significant in patients with International Staging System stages 2 to 3 and for patients with poor-risk cytogenetics t(4;14) or del(17p)., Conclusion: In the context of ASCT, achievement of at least VGPR is a simple prognostic factor that has importance in intermediate and high-risk MM and can be informative in more patients than CR.
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- 2009
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10. Effect of single-agent rituximab given at the standard schedule or as prolonged treatment in patients with mantle cell lymphoma: a study of the Swiss Group for Clinical Cancer Research (SAKK).
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Ghielmini M, Schmitz SF, Cogliatti S, Bertoni F, Waltzer U, Fey MF, Betticher DC, Schefer H, Pichert G, Stahel R, Ketterer N, Bargetzi M, and Cerny T
- Subjects
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal, Murine-Derived, Drug Administration Schedule, Female, Humans, Lymphoma, Mantle-Cell immunology, Lymphoma, Mantle-Cell mortality, Male, Middle Aged, Rituximab, Antibodies, Monoclonal administration & dosage, Antineoplastic Agents administration & dosage, Lymphoma, Mantle-Cell drug therapy
- Abstract
Purpose: To evaluate the effect of single-agent rituximab given at the standard or a prolonged schedule in patients with newly diagnosed, or refractory or relapsed mantle cell lymphoma (MCL)., Patients and Methods: After induction treatment with the standard schedule (375 mg/m2 weekly x 4), patients who were responding or who had stable disease at week 12 from the start of treatment were randomly assigned to no further treatment (arm A) or prolonged rituximab administration (375 mg/m2) every 8 weeks for four times (arm B)., Results: The trial enrolled 104 patients. After induction, clinical response was 27% with 2% complete responses. Among patients with detectable t(11;14)-positive cells in blood and bone marrow at baseline, four of 20, and one of 14, respectively, became polymerase chain-reaction-negative after induction. Anemia was the only adverse predictor of response in the multivariate analysis. After a median follow-up of 29 months, response rate and duration of response were not significantly different between the two schedules in 61 randomly assigned patients. Median event-free survival (EFS) was 6 months in arm A versus 12 months in arm B; the difference was not significant (P = .1). Prolonged treatment seemed to improve EFS in the subgroup of pretreated patients (5 months in arm A v 11 months in arm B; P = .04). Thirteen percent of patients in arm A and 9% in arm B presented with grade 3 to 4 hematologic toxicity., Conclusion: Single-agent rituximab is active in MCL, but the addition of four single doses at 8-week intervals does not seem to significantly improve response rate, duration of response, or EFS after treatment with the standard schedule.
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- 2005
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