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2. Phase I First-in-Human Study of Venetoclax in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Author

Davids, Matthew S, Roberts, Andrew W, Seymour, John F, Pagel, John M, Kahl, Brad S, Wierda, William G, Puvvada, Soham, Kipps, Thomas J, Anderson, Mary Ann, Salem, Ahmed Hamed, Dunbar, Martin, Zhu, Ming, Peale, Franklin, Ross, Jeremy A, Gressick, Lori, Desai, Monali, Kim, Su Young, Verdugo, Maria, Humerickhouse, Rod A, Gordon, Gary B, and Gerecitano, John F

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Cancer, Orphan Drug, Lymphatic Research, Hematology, Clinical Research, Rare Diseases, Lymphoma, 6.2 Cellular and gene therapies, 6.1 Pharmaceuticals, Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Bridged Bicyclo Compounds, Heterocyclic, Cohort Studies, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, Lymphoma, Non-Hodgkin, Male, Middle Aged, Sulfonamides, Clinical Sciences, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

Purpose B-cell leukemia/lymphoma-2 (BCL-2) overexpression is common in many non-Hodgkin lymphoma (NHL) subtypes. A phase I trial in patients with NHL was conducted to determine safety, pharmacokinetics, and efficacy of venetoclax, a selective, potent, orally bioavailable BCL-2 inhibitor. Patients and Methods A total of 106 patients with relapsed or refractory NHL received venetoclax once daily until progressive disease or unacceptable toxicity at target doses from 200 to 1,200 mg in dose-escalation and safety expansion cohorts. Treatment commenced with a 3-week dose ramp-up period for most patients in dose-escalation cohorts and for all patients in safety expansion. Results NHL subtypes included mantle cell lymphoma (MCL; n = 28), follicular lymphoma (FL; n = 29), diffuse large B-cell lymphoma (DLBCL; n = 34), DLBCL arising from chronic lymphocytic leukemia (Richter transformation; n = 7), Waldenström macroglobulinemia (n = 4), and marginal zone lymphoma (n = 3). Venetoclax was generally well tolerated. Clinical tumor lysis syndrome was not observed, whereas laboratory tumor lysis syndrome was documented in three patients. Treatment-emergent adverse events were reported in 103 patients (97%), a majority of which were grade 1 to 2 in severity. Grade 3 to 4 events were reported in 59 patients (56%), and the most common were hematologic, including anemia (15%), neutropenia (11%), and thrombocytopenia (9%). Overall response rate was 44% (MCL, 75%; FL, 38%; DLBCL, 18%). Estimated median progression-free survival was 6 months (MCL, 14 months; FL, 11 months; DLBCL, 1 month). Conclusion Selective targeting of BCL-2 with venetoclax was well tolerated, and single-agent activity varied among NHL subtypes. We determined 1,200 mg to be the recommended single-agent dose for future studies in FL and DLBCL, with 800 mg being sufficient to consistently achieve durable response in MCL. Additional investigations including combination therapy to augment response rates and durability are ongoing.

Published
2017

3. Venetoclax plus rituximab in relapsed or refractory chronic lymphocytic leukaemia: a phase 1b study

Author

Seymour, John F, Ma, Shuo, Brander, Danielle M, Choi, Michael Y, Barrientos, Jacqueline, Davids, Matthew S, Anderson, Mary Ann, Beaven, Anne W, Rosen, Steven T, Tam, Constantine S, Prine, Betty, Agarwal, Suresh K, Munasinghe, Wijith, Zhu, Ming, Lash, L Leanne, Desai, Monali, Cerri, Elisa, Verdugo, Maria, Kim, Su Young, Humerickhouse, Rod A, Gordon, Gary B, Kipps, Thomas J, and Roberts, Andrew W

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Clinical Trials and Supportive Activities, Rare Diseases, Patient Safety, Lymphoma, Lymphatic Research, Minority Health, Clinical Research, Cancer, Health Disparities, Hematology, 6.1 Pharmaceuticals, 6.2 Cellular and gene therapies, Good Health and Well Being, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Bridged Bicyclo Compounds, Heterocyclic, Cohort Studies, Drug Resistance, Neoplasm, Female, Follow-Up Studies, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Grading, Neoplasm Recurrence, Local, Prognosis, Remission Induction, Rituximab, Salvage Therapy, Sulfonamides, Survival Rate, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundSelective BCL2 inhibition with venetoclax has substantial activity in patients with relapsed or refractory chronic lymphocytic leukaemia. Combination therapy with rituximab enhanced activity in preclinical models. The aim of this study was to assess the safety, pharmacokinetics, and activity of venetoclax in combination with rituximab.MethodsAdult patients with relapsed or refractory chronic lymphocytic leukaemia (according to the 2008 Modified International Workshop on CLL guidelines) or small lymphocytic lymphoma were eligible for this phase 1b, dose-escalation trial. The primary outcomes were to assess the safety profile, to determine the maximum tolerated dose, and to establish the recommended phase 2 dose of venetoclax when given in combination with rituximab. Secondary outcomes were to assess the pharmacokinetic profile and analyse efficacy, including overall response, duration of response, and time to tumour progression. Minimal residual disease was a protocol-specified exploratory objective. Central review of the endpoints was not done. Venetoclax was dosed daily using a stepwise escalation to target doses (200-600 mg) and then monthly rituximab commenced (375 mg/m2 in month 1 and 500 mg/m2 in months 2-6). Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for adverse events version 4.0. Protocol-guided drug cessation was allowed for patients who achieved complete response (including complete response with incomplete marrow recovery) or negative bone marrow minimal residual disease. Analyses were done per protocol for all patients who commenced drug and included all patients who received at least one dose of venetoclax. Data were pooled across dose cohorts. Patients are still receiving therapy and follow-up is ongoing. The trial is registered at ClinicalTrials.gov, number NCT01682616.FindingsBetween Aug 6, 2012, and May 28, 2014, we enrolled 49 patients. Common grade 1-2 toxicities included upper respiratory tract infections (in 28 [57%] of 49 patients), diarrhoea (27 [55%]), and nausea (25 [51%]). Grade 3-4 adverse events occurred in 37 (76%) of 49 patients; most common were neutropenia (26 [53%]), thrombocytopenia (eight [16%]), anaemia (seven [14%]), febrile neutropenia (six [12%]), and leucopenia (six [12%]). The most common serious adverse events were pyrexia (six [12%]), febrile neutropenia (five [10%]), lower respiratory tract infection, and pneumonia (each three [6%]). Clinical tumour lysis syndrome occurred in two patients (resulting in one death) who initiated venetoclax at 50 mg. After enhancing tumour lysis syndrome prophylaxis measures and commencing venetoclax at 20 mg, clinical tumour lysis syndrome did not occur. The maximum tolerated dose was not identified; the recommended phase 2 dose of venetoclax in combination with rituximab was 400 mg. Overall, 42 (86%) of 49 patients achieved a response, including a complete response in 25 (51%) of 49 patients. 2 year estimates for progression-free survival and ongoing response were 82% (95% CI 66-91) and 89% (95% CI 72-96), respectively. Negative marrow minimal residual disease was attained in 20 (80%) of 25 complete responders and 28 (57%) of 49 patients overall. 13 responders ceased all therapy; among these all 11 minimal residual disease-negative responders remain progression-free off therapy. Two with minimal residual disease-positive complete response progressed after 24 months off therapy and re-attained response after re-initiation of venetoclax.InterpretationA substantial proportion of patients achieved an overall response with the combination of venetoclax and rituximab including 25 (51%) of 49 patients who achieved a complete response and 28 (57%) of 49 patients who achieved negative marrow minimal residual disease with acceptable safety. The depth and durability of responses observed with the combination offers an attractive potential treatment option for patients with relapsed or refractory chronic lymphocytic leukaemia and could allow some patients to maintain response after discontinuing therapy, a strategy that warrants further investigation in randomised studies.FundingAbbVie Inc and Genentech Inc.

Published
2017

4. From Research to Development on Virtual Language, Content and Intercultural Learning across European Schools

Author

Ramírez-Verdugo, Maria Dolores

Abstract

This paper presents an overview of the research conducted within a funded Comenius project which aims at developing a virtual European CLIL Resource Centre for Web 2.0 Education. E-CLIL focuses on Content and Language Integrated Learning (CLIL), creativity and multiculturalism through digital resources. In this sense, our prior research on CLIL programmes across Europe revealed the need to equip teachers with relevant methodological strategies and appropriate materials. We also detected the need of specific guidelines for implementation together with specific resources which should guarantee excellence in language learning (Ramírez-Verdugo, 2010). To reduce the identified shortcomings, an interdisciplinary group of scholars have developed a resource centre for Web 2.0 Education which aims at increasing children's exposure to European languages and to improve the quality of teaching and learning through the implementation of CLIL. E-CLIL has a three-folded objective. First, it intends to provide support to current and future CLIL educative programmes all over Europe and beyond. Accordingly, E-CLIL is currently disseminating high quality and proven materials and resources for content and language learning. Second, E-CLIL material design and the guideline for teachers are founded on sound language and content learning principles. Third, E-CLIL attempts to enrich teachers' and children's knowledge of other European cultures. The paper shows the results from the pilot study and initial experiences at E-CLIL school network across Europe. [For the complete volume, see ED574893.]

Published
2012

6. Phase 1b study of venetoclax-obinutuzumab in previously untreated and relapsed/refractory chronic lymphocytic leukemia

Author

Flinn, Ian W., Gribben, John G., Dyer, Martin J.S., Wierda, William, Maris, Michael B., Furman, Richard R., Hillmen, Peter, Rogers, Kerry A., Iyer, Swaminathan Padmanabhan, Quillet-Mary, Anne, Ysebaert, Loic, Walter, Harriet S., Verdugo, Maria, Klein, Christian, Huang, Huang, Jiang, Yanwen, Lozanski, Gerard, Pignataro, Daniela Soriano, Humphrey, Kathryn, Mobasher, Mehrdad, and Kipps, Thomas J.

Published
2019
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10. Efficacy of venetoclax as targeted therapy for relapsed/refractory t(11;14) multiple myeloma

Author

Kumar, Shaji, Kaufman, Jonathan L., Gasparetto, Cristina, Mikhael, Joseph, Vij, Ravi, Pegourie, Brigitte, Benboubker, Lofti, Facon, Thierry, Amiot, Martine, Moreau, Philippe, Punnoose, Elizabeth A., Alzate, Stefanie, Dunbar, Martin, Xu, Tu, Agarwal, Suresh K., Enschede, Sari Heitner, Leverson, Joel D., Ross, Jeremy A., Maciag, Paulo C., Verdugo, Maria, and Touzeau, Cyrille

Published
2017
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11. Promising efficacy and acceptable safety of venetoclax plus bortezomib and dexamethasone in relapsed/refractory MM

Author

Moreau, Philippe, Chanan-Khan, Asher, Roberts, Andrew W., Agarwal, Amit B., Facon, Thierry, Kumar, Shaji, Touzeau, Cyrille, Punnoose, Elizabeth A., Cordero, Jaclyn, Munasinghe, Wijith, Jia, Jia, Salem, Ahmed Hamed, Freise, Kevin J., Leverson, Joel D., Enschede, Sari Heitner, Ross, Jeremy A., Maciag, Paulo C., Verdugo, Maria, and Harrison, Simon J.

Published
2017
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12. S132: UPDATED RESULTS OF VEN-A-QUI STUDY: A PHASE 1-2 TRIAL TO ASSESS THE SAFETY AND EFFICACY OF TRIPLETS FOR NEWLY DIAGNOSED UNFIT AML PATIENTS: AZACITIDINE OR LOW-DOSE CYTARABINE WITH VENETOCLAX AND QUIZARTINIB

Author

Miguel Bergua Burgues, Juan, primary, Rodríguez-Veiga, Rebeca, additional, Cano Ferri, Isabel, additional, Vall-Llovera Calmet, Ferran, additional, Garcia-Guiñon, Antonio, additional, Gomez Espuch, Joaquin, additional, Colorado, Mercedes, additional, Casas-Avilés, Ignacio, additional, Esteve, Jordi, additional, Sampol, Antonia, additional, Victoria Verdugo, Maria, additional, Ramos, Fernando, additional, Valero, Marta, additional, Gloria Acuña Cruz, Evelyn, additional, Boluda, Blanca, additional, Torres Miñana, Laura, additional, Martinez-Lopez, Joaquín, additional, Barragan, Eva, additional, Ayala Diaz, Rosa, additional, Martinez-Cuadrón, David, additional, and Montesinos, Pau, additional

Published
2023
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13. Venetoclax in relapsed or refractory chronic lymphocytic leukaemia with 17p deletion: a multicentre, open-label, phase 2 study

Author

Stilgenbauer, Stephan, Eichhorst, Barbara, Schetelig, Johannes, Coutre, Steven, Seymour, John F, Munir, Talha, Puvvada, Soham D, Wendtner, Clemens-Martin, Roberts, Andrew W, Jurczak, Wojciech, Mulligan, Stephen P, Böttcher, Sebastian, Mobasher, Mehrdad, Zhu, Ming, Desai, Monali, Chyla, Brenda, Verdugo, Maria, Enschede, Sari Heitner, Cerri, Elisa, Humerickhouse, Rod, Gordon, Gary, Hallek, Michael, and Wierda, William G

Published
2016
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14. Supplementary Data from Comprehensive Safety Analysis of Venetoclax Monotherapy for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

Author

Davids, Matthew S., primary, Hallek, Michael, primary, Wierda, William, primary, Roberts, Andrew W., primary, Stilgenbauer, Stephan, primary, Jones, Jeffrey A., primary, Gerecitano, John F., primary, Kim, Su Young, primary, Potluri, Jalaja, primary, Busman, Todd, primary, Best, Andrea, primary, Verdugo, Maria E., primary, Cerri, Elisa, primary, Desai, Monali, primary, Hillmen, Peter, primary, and Seymour, John F., primary

Published
2023
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16. El nivel de estrés percibido en comerciantes de la plaza de san francisco de la ciudad de cuenca – Ecuador, año 2022

Author

Bustamante Verdugo, Maria Isabel, Avila Larrea, Javier Alejandro, Tenelema Salazar, Karina Elizabeth, Azanza La rosa, Celso Israel, Brito Brito, Karina Alexandra, Bustamante Verdugo, Maria Isabel, Avila Larrea, Javier Alejandro, Tenelema Salazar, Karina Elizabeth, Azanza La rosa, Celso Israel, and Brito Brito, Karina Alexandra

Abstract

The purpose of this research was to describe the levels of perceived stress in merchants of the Plaza San Francisco in the city of Cuenca. It was developed through a non-experimental quantitative approach of transversal cut, with descriptive scope. The sample taken was of 51 merchants of the San Francisco Plaza. The Perceived Stress Scale (PSS) with its corresponding informed consent was used as a data collection instrument. It was evidenced that the sample presents, mainly, moderate levels of perceived stress, ranging from 11 to 16 (41.2%). On the other hand, coping skills ranged from 13 to 18 points (49.0%), corresponding to low capacities to respond to stressors. It is concluded that the levels of Perceived Stress were moderate, and it is also evident that the highest percentage of traders do not possess coping skills useful for managing difficult and stressful situations. In relation to general distress, it was possible to demonstrate their high perception of stress in difficult situations, as well as their low control over them.

Published
2022

17. Deciphering the Properties of Different Arctic Ice Types During the Growth Phase of MOSAiC: Implications for Future Studies on Gas Pathways

Author

Angelopoulos, Michael, Damm, Ellen, Simoes Pereira, Patric, Abrahamsson, Katarina, Bauch, Dorothea, Bowman, Jeff, Castellani, Giulia, Creamean, Jessie, Divine, Dmitry V, Dumitrascu, Adela, Fons, Steven W, Granskog, Mats A, Kolabutin, Nikolai, Krumpen, Thomas, Marsay, Chris, Nicolaus, Marcel, Oggier, Marc, Rinke, Annette, Sachs, Torsten, Shimanchuk, Egor, Stefels, Jacqueline, Stephens, Mark, Ulfsbo, Adam, Verdugo, Maria Josefa, Wang, Lei, Zhan, Liyang, Haas, Christian, Angelopoulos, Michael, Damm, Ellen, Simoes Pereira, Patric, Abrahamsson, Katarina, Bauch, Dorothea, Bowman, Jeff, Castellani, Giulia, Creamean, Jessie, Divine, Dmitry V, Dumitrascu, Adela, Fons, Steven W, Granskog, Mats A, Kolabutin, Nikolai, Krumpen, Thomas, Marsay, Chris, Nicolaus, Marcel, Oggier, Marc, Rinke, Annette, Sachs, Torsten, Shimanchuk, Egor, Stefels, Jacqueline, Stephens, Mark, Ulfsbo, Adam, Verdugo, Maria Josefa, Wang, Lei, Zhan, Liyang, and Haas, Christian

Published
2022

18. Evolution of physical properties of sea ice for multiple ice types at the MOSAiC central floe and the distributed network

Author

Angelopoulos, Michael, Damm, Ellen, Simoes Pereira, Patric, Abrahamsson, Katarina, Bauch, Dorothea, Bowman, Jeff, Dumitrascu, Adela, Krumpen, Thomas, Marsay, Chris, Nomura, Daiki, Rinke, Annette, Stefels, Jacqueline, Sachs, Torsten, Stephens, Mark, Verdugo, Maria Josefa, Wang, Lei, Zhan, Liyang, Angelopoulos, Michael, Damm, Ellen, Simoes Pereira, Patric, Abrahamsson, Katarina, Bauch, Dorothea, Bowman, Jeff, Dumitrascu, Adela, Krumpen, Thomas, Marsay, Chris, Nomura, Daiki, Rinke, Annette, Stefels, Jacqueline, Sachs, Torsten, Stephens, Mark, Verdugo, Maria Josefa, Wang, Lei, and Zhan, Liyang

Published
2021

19. Sea ice permeability evolution on Arctic first and second-year ice on the drifting MOSAiC floe from autumn to spring

Author

Angelopoulos, Michael, Damm, Ellen, Simoes Pereira, Patric, Abrahamsson, Katarina, Bauch, Dorothea, Bowman, Jeff, Dumitrascu, Adela, Krumpen, Thomas, Marsay, Chris, Rinke, Annette, Stefels, Jacqueline, Sachs, Torsten, Stephens, Mark, Verdugo, Maria Josefa, Wang, Lei, Zhan, Liyang, Angelopoulos, Michael, Damm, Ellen, Simoes Pereira, Patric, Abrahamsson, Katarina, Bauch, Dorothea, Bowman, Jeff, Dumitrascu, Adela, Krumpen, Thomas, Marsay, Chris, Rinke, Annette, Stefels, Jacqueline, Sachs, Torsten, Stephens, Mark, Verdugo, Maria Josefa, Wang, Lei, and Zhan, Liyang

Published
2021

20. Spatial variability and evolution of sea ice permeability on the MOSAiC central floe from autumn to spring: Biogeochemistry research sites

Author

Angelopoulos, Michael, Damm, Ellen, Simoes Pereira, Patric, Abrahamsson, Katarina, Bauch, Dorothea, Bowman, Jeff, Dumitrascu, Adela, Krumpen, Thomas, Marsay, Chris, Oggier, Marc, Rinke, Annette, Stefels, Jacqueline, Sachs, Torsten, Stephens, Mark, Verdugo, Maria Josefa, Wang, Lei, Zhan, Liyang, Haas, Christian, Angelopoulos, Michael, Damm, Ellen, Simoes Pereira, Patric, Abrahamsson, Katarina, Bauch, Dorothea, Bowman, Jeff, Dumitrascu, Adela, Krumpen, Thomas, Marsay, Chris, Oggier, Marc, Rinke, Annette, Stefels, Jacqueline, Sachs, Torsten, Stephens, Mark, Verdugo, Maria Josefa, Wang, Lei, Zhan, Liyang, and Haas, Christian

Published
2021

23. Cover Image, Volume 39, Issue 9

Author

Aleo, Michael D., primary, Doshna, Colleen M., additional, Baltrukonis, Daniel, additional, Fortner, Jay H., additional, Drupa, Cynthia A., additional, Navetta, Kimberly A., additional, Fritz, Carol A., additional, Potter, David M., additional, Verdugo, Maria E., additional, and Beierschmitt, William P., additional

Published
2019
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24. Lens cholesterol biosynthesis inhibition: A common mechanism of cataract formation in laboratory animals by pharmaceutical products

Author

Aleo, Michael D., primary, Doshna, Colleen M., additional, Baltrukonis, Daniel, additional, Fortner, Jay H., additional, Drupa, Cynthia A., additional, Navetta, Kimberly A., additional, Fritz, Carol A., additional, Potter, David M., additional, Verdugo, Maria E., additional, and Beierschmitt, William P., additional

Published
2019
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25. Utility of positron emission tomography-computed tomography in patients with chronic lymphocytic leukemia following B-cell receptor pathway inhibitor therapy

Author

Mato, Anthony R., primary, Wierda, William G., additional, Davids, Matthew S., additional, Cheson, Bruce D., additional, Coutre, Steven E., additional, Choi, Michael, additional, Furman, Richard R., additional, Heffner, Leonard, additional, Barr, Paul M., additional, Eradat, Herbert, additional, Ford, Sharanya M., additional, Zhou, Lang, additional, Verdugo, Maria, additional, Humerickhouse, Rod A., additional, Potluri, Jalaja, additional, and Byrd, John C., additional

Published
2019
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26. Fixed Duration of Venetoclax-Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia Eradicates Minimal Residual Disease and Prolongs Survival: Post-Treatment Follow-Up of the MURANO Phase III Study

Author

Kater, Arnon P., Seymour, John F., Hillmen, Peter, Eichhorst, Barbara, Langerak, Anton W., Owen, Carolyn, Verdugo, Maria, Wu, Jenny, Punnoose, Elizabeth A., Jiang, Yanwen, Wang, Jue, Boyer, Michelle, Humphrey, Kathryn, Mobasher, Mehrdad, Kipps, Thomas J., Kater, Arnon P., Seymour, John F., Hillmen, Peter, Eichhorst, Barbara, Langerak, Anton W., Owen, Carolyn, Verdugo, Maria, Wu, Jenny, Punnoose, Elizabeth A., Jiang, Yanwen, Wang, Jue, Boyer, Michelle, Humphrey, Kathryn, Mobasher, Mehrdad, and Kipps, Thomas J.

Abstract

PURPOSE The MURANO study demonstrated significant progression-free survival (PFS) benefit for fixedduration venetoclax-rituximab compared with bendamustine-rituximab in relapsed/refractory chronic lymphocytic leukemia. With all patients off treatment, we report minimal residual disease (MRD) kinetics and updated outcomes. METHODS Patients were randomly assigned to 2 years of venetoclax plus rituximab during the first six cycles, or six cycles of bendamustine-rituximab. Primary end point was PFS. Safety and peripheral blood (PB) MRD status-at cycle 4, 2 to 3 months after end of combination therapy (EOCT), and every 3 to 6 months thereafter-were secondary end points. RESULTS Of 194 patients, 174 (90%) completed the venetoclax-rituximab phase and 130 (67%) completed 2 years of venetoclax. With a median follow-up of 36 months, PFS and overall survival remain superior to bendamustine-rituximab (hazard ratio, 0.16 [95% CI, 0.12 to 0.23]; and hazard ratio, 0.50 [95% CI, 0.30 to 0.85], respectively). Patients who received venetoclax-rituximab achieved a higher rate of PB undetectable MRD (uMRD; less than 10(-4)) at EOCT (62% v 13%) with superiority sustained through month 24 (end of therapy). Overall, uMRD status at EOCT predicted longer PFS. Among those with detectable MRD, low-level MRD (1024 to less than 10(-2)) predicted improved PFS compared with high-level MRD (1022 or greater). At a median of 9.9 months (range, 1.4 to 22.5 months) after completing fixed-duration venetoclax-rituximab, overall only 12% (16 of 130) of patients developed disease progression (11 high-level MRD, three low-level MRD). At the end of therapy, 70% and 98% of patients with uMRD remained in uMRD and without disease progression, respectively. CONCLUSION With all patients having finished treatment, continued benefit was observed for venetoclaxrituximab compared with bendamustine-rituximab. uMRD rates were durable and predicted longer PFS, which establishes the impact of PB MRD on the benefit of fi

Published
2019

27. Clinical characteristics of post-appendectomy patients from Hospital Homero Castanier Crespo, Ecuador

Author

Ordoñez Cumbe, Julio Cesar, Alomia Castro, Paul Esteban, Rodas Torres, Americo Gerardo, Gallegos Vintimilla, Santiago Homero, Palomeque Molina, Josue Miguel, Vazquez Verdugo, Maria Patricia, Asitimbay Regalado, Maria Gabriela, Sinchi Chuqui, Carlos Andres, Rojas Lojano, Maria Gabriela, Caceres Guaman, Mercedes Alexandra, Ordoñez Cumbe, Julio Cesar, Alomia Castro, Paul Esteban, Rodas Torres, Americo Gerardo, Gallegos Vintimilla, Santiago Homero, Palomeque Molina, Josue Miguel, Vazquez Verdugo, Maria Patricia, Asitimbay Regalado, Maria Gabriela, Sinchi Chuqui, Carlos Andres, Rojas Lojano, Maria Gabriela, and Caceres Guaman, Mercedes Alexandra

Abstract

Objective: To determine the clinical characteristics of post appendectomy patients from the Hospital Homero Castanier Crespo, Ecuador. Materials and methods: A descriptive and retrospective study was carried out in patients admitted with a diagnosis of Acute Appendicitis to the surgery department of the mentioned hospital, during the period November 2014 to April 2015. These patients underwent open appendectomy and antibiotic prophylaxis with cefazolin administered preop-eratively. The clinical data of the histories found in the department of medical records were used. Results: Out of the 132 patients evaluated, 53% (n=70) were female, the most frequent age group was 12-20 years (43.2%; n=57), the urban origin was the most frequent (56.1%; n=74), the catarrhal phase was the most common found in the transoperative period (52.3%; n=69), only 27.3%; n=36 presented infection of the operative site and the time interval between 30-60 minutes was the most common for the administration of antibiotic prophylaxis. Conclusion: The post appendectomy patients from the Hospital Homero Castanier Crespo in Azogues, Ecuador; showed similar clinical characteristics to previous reports, but despite receiving antibiotic prophylaxis they presented a high frequency of infection of the operative site. © 2019, Sociedad Venezolana de Farmacologia y de Farmacologia Clinica y Terapeutica. All rights reserved.

Published
2019

29. Fixed Duration of Venetoclax-Rituximab in Relapsed/Refractory Chronic Lymphocytic Leukemia Eradicates Minimal Residual Disease and Prolongs Survival: Post-Treatment Follow-Up of the MURANO Phase III Study

Author

Kater, Arnon P., primary, Seymour, John F., additional, Hillmen, Peter, additional, Eichhorst, Barbara, additional, Langerak, Anton W., additional, Owen, Carolyn, additional, Verdugo, Maria, additional, Wu, Jenny, additional, Punnoose, Elizabeth A., additional, Jiang, Yanwen, additional, Wang, Jue, additional, Boyer, Michelle, additional, Humphrey, Kathryn, additional, Mobasher, Mehrdad, additional, and Kipps, Thomas J., additional

Published
2019
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31. Durability of Responses on Continuous Therapy and Following Drug Cessation in Deep Responders with Venetoclax and Rituximab

Author

Brander, Danielle M., primary, Seymour, John F., additional, Ma, Shuo, additional, Anderson, Mary Ann, additional, Choi, Michael Y., additional, Kipps, Thomas J., additional, Humphrey, Kathryn, additional, Masud, Abdullah, additional, Nandam, Ruby, additional, Kim, Su Young, additional, Verdugo, Maria E., additional, and Roberts, Andrew W., additional

Published
2018
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32. MURANO Trial Establishes Feasibility of Time-Limited Venetoclax-Rituximab (VenR) Combination Therapy in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)

Author

Seymour, John F., primary, Kipps, Thomas J., additional, Eichhorst, Barbara, additional, Hillmen, Peter, additional, D'Rozario, James, additional, Assouline, Sarit, additional, Owen, Carolyn, additional, Robak, Tadeusz, additional, de la Serna, Javier, additional, Jaeger, Ulrich, additional, Cartron, Guillaume, additional, Montillo, Marco, additional, Lamanna, Nicole, additional, Verdugo, Maria E., additional, Punnoose, Elizabeth A, additional, Jiang, Yanwen, additional, Wang, Jue, additional, Boyer, Michelle, additional, Humphrey, Kathryn, additional, Mobasher, Mehrdad, additional, and Kater, Arnon P., additional

Published
2018
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33. First Prospective Data on Impact of Minimal Residual Disease on Long-Term Clinical Outcomes after Venetoclax Plus Rituximab Versus Bendamustine Plus Rituximab: Phase III MURANO Study

Author

Kater, Arnon P., primary, Hillmen, Peter, additional, Eichhorst, Barbara, additional, Langerak, Anton W, additional, Kipps, Thomas J., additional, Owen, Carolyn, additional, Boyer, Michelle, additional, Humphrey, Kathryn, additional, Punnoose, Elizabeth A, additional, Wang, Jue, additional, Chyla, Brenda, additional, Verdugo, Maria E., additional, Wu, Jenny, additional, Jiang, Yanwen, additional, Mobasher, Mehrdad, additional, and Seymour, John F., additional

Published
2018
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35. Venetoclax for chronic lymphocytic leukaemia patients who progress after more than one B‐cell receptor pathway inhibitor

Author

Wierda, William G., primary, Byrd, John C., additional, Davids, Matthew S., additional, Furman, Richard R., additional, Cheson, Bruce D., additional, Barr, Paul M., additional, Eradat, Herbert, additional, Heffner, Leonard, additional, Zhou, Lang, additional, Verdugo, Maria, additional, Potluri, Jalaja, additional, and Choi, Michael, additional

Published
2018
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36. Comprehensive Safety Analysis of Venetoclax Monotherapy for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

Author

Davids, Matthew S., primary, Hallek, Michael, additional, Wierda, William, additional, Roberts, Andrew W., additional, Stilgenbauer, Stephan, additional, Jones, Jeffrey A., additional, Gerecitano, John F., additional, Kim, Su Young, additional, Potluri, Jalaja, additional, Busman, Todd, additional, Best, Andrea, additional, Verdugo, Maria E., additional, Cerri, Elisa, additional, Desai, Monali, additional, Hillmen, Peter, additional, and Seymour, John F., additional

Published
2018
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37. Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies

Author

Place, Andrew E, primary, Goldsmith, Kelly, additional, Bourquin, Jean-Pierre, additional, Loh, Mignon L, additional, Gore, Lia, additional, Morgenstern, Daniel A, additional, Sanzgiri, Yeshwant, additional, Hoffman, David, additional, Zhou, Ying, additional, Ross, Jeremy A, additional, Prine, Betty, additional, Shebley, Mohamad, additional, McNamee, Megan, additional, Farazi, Thalia, additional, Kim, Su Young, additional, Verdugo, Maria, additional, Lash-Fleming, Leanne, additional, Zwaan, C Michel, additional, and Vormoor, Josef, additional

Published
2018
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38. Venetoclax for Patients With Chronic Lymphocytic Leukemia With 17p Deletion: Results From the Full Population of a Phase II Pivotal Trial

Author

Stilgenbauer, Stephan, primary, Eichhorst, Barbara, additional, Schetelig, Johannes, additional, Hillmen, Peter, additional, Seymour, John F., additional, Coutre, Steven, additional, Jurczak, Wojciech, additional, Mulligan, Stephen P., additional, Schuh, Anna, additional, Assouline, Sarit, additional, Wendtner, Clemens-Martin, additional, Roberts, Andrew W., additional, Davids, Matthew S., additional, Bloehdorn, Johannes, additional, Munir, Talha, additional, Böttcher, Sebastian, additional, Zhou, Lang, additional, Salem, Ahmed Hamed, additional, Desai, Monali, additional, Chyla, Brenda, additional, Arzt, Jennifer, additional, Kim, Su Young, additional, Verdugo, Maria, additional, Gordon, Gary, additional, Hallek, Michael, additional, and Wierda, William G., additional

Published
2018
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39. Open-label, dose-escalation, phase 1 study of venetoclax in combination with navitoclax and chemotherapy in patients with relapsed acute lymphoblastic leukemia.

Author

Alexander, Thomas, primary, Khaw, Seong Lin, additional, Rubnitz, Jeffrey E., additional, Vear, Susan I., additional, Lacayo, Norman James, additional, Schmidt, Michelle, additional, Tong, Bo, additional, Rosenwinkel, Lindsey, additional, Bensman, Lindsey, additional, Verdugo, Maria, additional, Kim, Su Young, additional, Jabbour, Elias, additional, and Stock, Wendy, additional

Published
2018
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41. Mitigation of tumor lysis syndrome (TLS) complications with venetoclax (VEN) in CLL.

Author

Davids, Matthew Steven, primary, Seymour, John Francis, additional, Roberts, Andrew Warwick, additional, Eichhorst, Barbara, additional, Kipps, Thomas J., additional, Mato, Anthony R., additional, Stilgenbauer, Stephan, additional, Mobasher, Mehrdad, additional, Desai, Monali Bhardwaj, additional, Potluri, Jalaja, additional, Pena, German E., additional, Verdugo, Maria E., additional, Nielsen, Jacqueline, additional, Cyr, Aimee, additional, Lash Fleming, Leanne, additional, and Hallek, Michael J., additional

Published
2018
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42. Mitigation of tumor lysis syndrome (TLS) complications with venetoclax (VEN) in CLL.

Author

Davids, Matthew Steven, Seymour, John Francis, Roberts, Andrew Warwick, Eichhorst, Barbara, Kipps, Thomas J., Mato, Anthony R., Stilgenbauer, Stephan, Mobasher, Mehrdad, Desai, Monali Bhardwaj, Potluri, Jalaja, Pena, German E., Verdugo, Maria E., Nielsen, Jacqueline, Cyr, Aimee, Fleming, Leanne Lash, Hallek, Michael J., Davids, Matthew Steven, Seymour, John Francis, Roberts, Andrew Warwick, Eichhorst, Barbara, Kipps, Thomas J., Mato, Anthony R., Stilgenbauer, Stephan, Mobasher, Mehrdad, Desai, Monali Bhardwaj, Potluri, Jalaja, Pena, German E., Verdugo, Maria E., Nielsen, Jacqueline, Cyr, Aimee, Fleming, Leanne Lash, and Hallek, Michael J.

Published
2018

43. Venetoclax for Patients With Chronic Lymphocytic Leukemia With 17p Deletion: Results From the Full Population of a Phase II Pivotal Trial

Author

Stilgenbauer, Stephan, Eichhorst, Barbara, Schetelig, Johannes, Hillmen, Peter, Seymour, John F., Coutre, Steven, Jurczak, Wojciech, Mulligan, Stephen P., Schuh, Anna, Assouline, Sarit, Wendtner, Clemens-Martin, Roberts, Andrew W., Davids, Matthew S., Bloehdorn, Johannes, Munir, Talha, Boettcher, Sebastian, Zhou, Lang, Salem, Ahmed Hamed, Desai, Monali, Chyla, Brenda, Arzt, Jennifer, Kim, Su Young, Verdugo, Maria, Gordon, Gary, Hallek, Michael, Wierda, William G., Stilgenbauer, Stephan, Eichhorst, Barbara, Schetelig, Johannes, Hillmen, Peter, Seymour, John F., Coutre, Steven, Jurczak, Wojciech, Mulligan, Stephen P., Schuh, Anna, Assouline, Sarit, Wendtner, Clemens-Martin, Roberts, Andrew W., Davids, Matthew S., Bloehdorn, Johannes, Munir, Talha, Boettcher, Sebastian, Zhou, Lang, Salem, Ahmed Hamed, Desai, Monali, Chyla, Brenda, Arzt, Jennifer, Kim, Su Young, Verdugo, Maria, Gordon, Gary, Hallek, Michael, and Wierda, William G.

Abstract

PurposeVenetoclax is an orally bioavailable B-cell lymphoma 2 inhibitor. US Food and Drug Administration and European Medicines Agency approval for patients with 17p deleted relapsed/refractory chronic lymphocytic leukemia [del(17p) CLL] was based on results from 107 patients. An additional 51 patients were enrolled in a safety expansion cohort. Extended analysis of all enrolled patients, including the effect of minimal residual disease (MRD) negativity on outcome, is now reported.Patients and MethodsOverall, 158 patients with relapsed/refractory or previously untreated (n = 5) del(17p) CLL received venetoclax 400 mg per day after an initial dose ramp up. Responses were based on 2008 International Workshop on Chronic Lymphocytic Leukemia criteria, with monthly physical exams and blood counts. Computed tomography scan was mandatory at week 36, after which assessment made was by clinical evaluation. Marrow biopsy was performed when complete remission was suspected. MRD was assessed by flow cytometry.ResultsPatients had a median of two prior therapies (range, zero to 10 therapies), 71% had TP53 mutation, and 48% had nodes that were 5 cm. Median time on venetoclax was 23.1 months (range, 0 to 44.2 months) and median time on study was 26.6 months (range, 0 to 44.2 months). For all patients, investigator-assessed objective response rate was 77% (122 of 158 patients; 20% complete remission) and estimated progression-free survival at 24 months was 54% (95% CI, 45% to 62%). For 16 patients who received prior kinase inhibitors, objective response rate was 63% (10 of 16 patients) and 24-month progression-free survival estimate was 50% (95% CI, 25% to 71%). By intent-to-treat analysis, 48 (30%) of 158 patients achieved MRD below the cutoff of 10(-4) in blood. Common grade 3 and 4 adverse events were hematologic and managed with supportive care and/or dose adjustments.ConclusionVenetoclax achieves durable responses and was well tolerated in patients with del(17p) CLL. A high rat

Published
2018

44. Comprehensive Safety Analysis of Venetoclax Monotherapy for Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia

Author

Davids, Matthew S., Hallek, Michael, Wierda, William, Roberts, Andrew W., Stilgenbauer, Stephan, Jones, Jeffrey A., Gerecitano, John F., Kim, Su Young, Potluri, Jalaja, Busman, Todd, Best, Andrea, Verdugo, Maria E., Cerri, Elisa, Desai, Monali, Hillmen, Peter, Seymour, John F., Davids, Matthew S., Hallek, Michael, Wierda, William, Roberts, Andrew W., Stilgenbauer, Stephan, Jones, Jeffrey A., Gerecitano, John F., Kim, Su Young, Potluri, Jalaja, Busman, Todd, Best, Andrea, Verdugo, Maria E., Cerri, Elisa, Desai, Monali, Hillmen, Peter, and Seymour, John F.

Abstract

Purpose: The oral BCL-2 inhibitor venetoclax is an effective therapy for patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), including disease with high-risk genomic features such as chromosome 17p deletion [del (17p)] or progressive disease following B-cell receptor pathway inhibitors. Patients and Methods: We conducted a comprehensive analysis of the safety of 400 mg daily venetoclax monotherapy in 350 patients with CLL using an integrated dataset from three phase I/II studies. Results: Median age was 66 years and 60% had del(17p). Patients had received a median of three prior therapies (range: 0-15); 42% previously received ibrutinib or idelalisib. Median duration of exposure to venetoclax was 16 months (0-56). In the pooled analysis, the most common adverse events (AE) of any grade were diarrhea (41%), neutropenia (40%), nausea (39%), anemia (31%), fatigue (28%), and upper respiratory tract infection (25%). The most common grade 3/4 AEs were neutropenia (37%), anemia (17%), and thrombocytopenia (14%). With the current 5-week ramp-up dosing, the incidence of laboratory TLS was 1.4% (2/166), none had clinical sequelae, and all of these patients were able to ramp-up to a daily dose of 400 mg. Grade 3/4 neutropenia was manageable with growth factor support and dose adjustments; the incidence of serious infections in these patients was 15%. Ten percent of patients discontinued venetoclax due to AEs and 8% died while on study, with the majority of deaths in the setting of disease progression. Conclusions: Venetoclax as a long-term continuous therapy is generally well tolerated in patients with R/R CLL when initiated with the current treatment algorithm. (C) 2018 AACR.

Published
2018

45. First Prospective Data on Impact of Minimal Residual Disease on Long - Term Clinical Outcomes after Venetoclax Plus Rituximab Versus Bendamustine Plus Rituximab: Phase III MURANO Study

Author

Kater, Arnon P., Hillmen, Peter, Eichhorst, Barbara, Langerak, Anton W., Kipps, Thomas J., Owen, Carolyn, Boyer, Michelle, Humphrey, Kathryn, Punnoose, Elizabeth A., Wang, Jue, Chyla, Brenda, Verdugo, Maria E., Wu, Jenny, Jiang, Yanwen, Mobasher, Mehrdad, Seymour, John F., Kater, Arnon P., Hillmen, Peter, Eichhorst, Barbara, Langerak, Anton W., Kipps, Thomas J., Owen, Carolyn, Boyer, Michelle, Humphrey, Kathryn, Punnoose, Elizabeth A., Wang, Jue, Chyla, Brenda, Verdugo, Maria E., Wu, Jenny, Jiang, Yanwen, Mobasher, Mehrdad, and Seymour, John F.

Published
2018

46. MURANO Trial Establishes Feasibility of Time-Limited Venetoclax-Rituximab (VenR) Combination Therapy in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)

Author

Seymour, John F., Kipps, Thomas J., Eichhorst, Barbara, Hillmen, Peter, D'Rozario, James, Assouline, Sarit, Owen, Carolyn, Robak, Tadeusz, de la Serna, Javier, Jaeger, Ulrich, Cartron, Guillaume, Montillo, Marco, Lamanna, Nicole, Verdugo, Maria E., Punnoose, Elizabeth A., Jiang, Yanwen, Wang, Jue, Boyer, Michelle, Humphrey, Kathryn, Mobasher, Mehrdad, Kater, Arnon P., Seymour, John F., Kipps, Thomas J., Eichhorst, Barbara, Hillmen, Peter, D'Rozario, James, Assouline, Sarit, Owen, Carolyn, Robak, Tadeusz, de la Serna, Javier, Jaeger, Ulrich, Cartron, Guillaume, Montillo, Marco, Lamanna, Nicole, Verdugo, Maria E., Punnoose, Elizabeth A., Jiang, Yanwen, Wang, Jue, Boyer, Michelle, Humphrey, Kathryn, Mobasher, Mehrdad, and Kater, Arnon P.

Published
2018

47. Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies

Author

Place, Andrew E, Goldsmith, Kelly, Bourquin, Jean-Pierre, Loh, Mignon L, Gore, Lia, Morgenstern, Daniel A, Sanzgiri, Yeshwant, Hoffman, David, Zhou, Ying, Ross, Jeremy A, Prine, Betty, Shebley, Mohamad, McNamee, Megan, Farazi, Thalia, Kim, Su Young, Verdugo, Maria, Lash-Fleming, Leanne, Zwaan, C Michel, Vormoor, Josef, Place, Andrew E, Goldsmith, Kelly, Bourquin, Jean-Pierre, Loh, Mignon L, Gore, Lia, Morgenstern, Daniel A, Sanzgiri, Yeshwant, Hoffman, David, Zhou, Ying, Ross, Jeremy A, Prine, Betty, Shebley, Mohamad, McNamee, Megan, Farazi, Thalia, Kim, Su Young, Verdugo, Maria, Lash-Fleming, Leanne, Zwaan, C Michel, and Vormoor, Josef

Abstract

Venetoclax is a highly selective, potent BCL-2 inhibitor that is approved for some patients previously treated for chronic lymphocytic leukemia, and has shown promising activity in adult studies across several hematologic malignancies. Preclinical studies have demonstrated venetoclax activity in pediatric patient-derived xenograft models and cell lines; however, clinical studies in pediatric patients have yet to be conducted. The prognosis is poor for children with most relapsed/refractory malignancies, and limited treatment options result in unmet clinical need. Herein, we describe the rationale and design of the first study of venetoclax in pediatric patients with relapsed/refractory malignancies: a Phase I trial investigating the safety and pharmacokinetics of venetoclax monotherapy followed by the addition of chemotherapy (Trial registration: EudraCT 2017-000439-14; NCT03236857).

Published
2018

48. Analysis of PET-CT to Identify Richter's Transformation in 167 Patients with Disease Progression Following Kinase Inhibitor Therapy

Author

Mato, Anthony R., primary, Wierda, William G, additional, Davids, Matthew S., additional, Cheson, Bruce D., additional, Coutre, Steven, additional, Choi, Michael, additional, Furman, Richard R., additional, Heffner, Leonard, additional, Barr, Paul M., additional, Eradat, Herbert, additional, Zhou, Lang, additional, Verdugo, Maria, additional, Potluri, Jalaja, additional, and Jones, Jeffrey, additional

Published
2017
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49. Venetoclax in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) with 17p Deletion: Outcome and Minimal Residual Disease (MRD) from the Full Population of the Pivotal M13-982 Trial

Author

Wierda, William, primary, Chyla, Brenda, additional, Eichhorst, Barbara, additional, Schetelig, Johannes, additional, Munir, Talha, additional, Hillmen, Peter, additional, Seymour, John F., additional, Roberts, Andrew W., additional, Coutre, Steven, additional, Jurczak, Wojciech, additional, Mulligan, Stephen P., additional, Wendtner, Clemens-Martin, additional, Davids, Matthew, additional, Böettcher, Sebastian, additional, Cerri, Elisa, additional, Zhou, Lang, additional, Popovic, Relja, additional, Poteracki, Mia, additional, Arzt, Jennifer, additional, Kim, Su Young, additional, Verdugo, Maria, additional, Bhathena, Anahita, additional, Stilgenbauer, Stephan, additional, and Hallek, Michael, additional

Published
2017
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