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11 results on '"Sivcheva, Liliya"'

1. Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14): follow-up results from a multicentre, open-label, randomised, phase 3 trial

Author

Al-Sawaf, Othman, Zhang, Can, Tandon, Maneesh, Sinha, Arijit, Fink, Anna-Maria, Robrecht, Sandra, Samoylova, Olga, Liberati, Anna M, Pinilla-Ibarz, Javier, Opat, Stephen, Sivcheva, Liliya, Le Dû, Katell, Fogliatto, Laura M, Niemann, Carsten U, Weinkove, Robert, Robinson, Sue, Kipps, Thomas J, Tausch, Eugen, Schary, William, Ritgen, Matthias, Wendtner, Clemens-Martin, Kreuzer, Karl-Anton, Eichhorst, Barbara, Stilgenbauer, Stephan, Hallek, Michael, and Fischer, Kirsten

Published
2020
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2. S145: VENETOCLAX-OBINUTUZUMAB FOR PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA: 6-YEAR RESULTS OF THE RANDOMIZED CLL14 STUDY

Author

Al-Sawaf, Othman, primary, Robrecht, Sandra, additional, Zhang, Can, additional, Olivieri, Stefano, additional, Chang, Yi Meng, additional, Fink, Anna-Maria, additional, Tausch, Eugen, additional, Schneider, Christof, additional, Ritgen, Matthias, additional, Kreuzer, Karl-Anton, additional, Sivcheva, Liliya, additional, Niemann, Carsten, additional, Schwarer, Anthony, additional, Loscertales Pueyo, Javier, additional, Weinkove, Robert, additional, Strumberg, Dirk, additional, Kilfoyle, Allanah, additional, Runkel, Eva, additional, Eichhorst, Barbara, additional, Stilgenbauer, Stephan, additional, Jiang, Yanwen, additional, Hallek, Michael, additional, and Fischer, Kirsten, additional

Published
2023
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3. Endpoint Surrogacy in Chronic Lymphocytic Leukemia: A Pooled Analysis of the German CLL Study Group

Author

Simon, Florian, Ligtvoet, Rudy, Robrecht, Sandra, Cramer, Paula, Kutsch, Nadine, Furstenau, Moritz, Goede, Valentin, Von Tresckow, Julia, Langerbeins, Petra, Fink, Anna-Maria, Huber, Henriette, Tausch, Eugen, Schneider, Christof, Wendtner, Clemens-Martin, Ritgen, Matthias, Dreyling, Martin, Müller, Lothar, Jacobasch, Lutz, Heinz, Werner, Vehling-Kaiser, Ursula, Sivcheva, Liliya, Böttcher, Sebastian, Dreger, Peter, Illmer, Thomas, Gregor, Michael, Staber, Philipp Bernhard, Stilgenbauer, Stephan, Niemann, Carsten Utoft, Kater, Arnon P., Fischer, Kirsten, Eichhorst, Barbara F., Hallek, Michael, and Al-Sawaf, Othman

Published
2023
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4. The Impact of Fitness and Dose Intensity on Safety and Efficacy Outcomes after Venetoclax-Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia

Author

Al-Sawaf, Othman, Fürstenau, Moritz, Giza, Adam, Robrecht, Sandra, Von Tresckow, Julia, Fink, Anna Maria, Simon, Florian, Tausch, Eugen, Schneider, Christof, Sivcheva, Liliya, Schwarer, Anthony, Loscertales, Javier, Weinkove, Robert, Strumberg, Dirk, Kilfoyle, Allanah R., Juliusson, Gunnar, Da Cunha-Bang, Caspar, Illmer, Thomas, Gregor, Michael, Thornton, Patrick, Janssens, Ann, Tadmor, Tamar, Lindström, Vesa, Staber, Philipp Bernhard, Levin, Mark-David, Wendtner, Clemens-Martin, Kreuzer, Karl-Anton, Ritgen, Matthias, Stilgenbauer, Stephan, Kater, Arnon P., Niemann, Carsten Utoft, Fischer, Kirsten, Eichhorst, Barbara F., and Hallek, Michael

Published
2023
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6. Venetoclax plus obinutuzumab versus chlorambucil plus obinutuzumab for previously untreated chronic lymphocytic leukaemia (CLL14):follow-up results from a multicentre, open-label, randomised, phase 3 trial

Author

Al-Sawaf, Othman, Zhang, Can, Tandon, Maneesh, Sinha, Arijit, Fink, Anna Maria, Robrecht, Sandra, Samoylova, Olga, Liberati, Anna M., Pinilla-Ibarz, Javier, Opat, Stephen, Sivcheva, Liliya, Le Dû, Katell, Fogliatto, Laura M., Niemann, Carsten U., Weinkove, Robert, Robinson, Sue, Kipps, Thomas J., Tausch, Eugen, Schary, William, Ritgen, Matthias, Wendtner, Clemens Martin, Kreuzer, Karl Anton, Eichhorst, Barbara, Stilgenbauer, Stephan, Hallek, Michael, Fischer, Kirsten, Al-Sawaf, Othman, Zhang, Can, Tandon, Maneesh, Sinha, Arijit, Fink, Anna Maria, Robrecht, Sandra, Samoylova, Olga, Liberati, Anna M., Pinilla-Ibarz, Javier, Opat, Stephen, Sivcheva, Liliya, Le Dû, Katell, Fogliatto, Laura M., Niemann, Carsten U., Weinkove, Robert, Robinson, Sue, Kipps, Thomas J., Tausch, Eugen, Schary, William, Ritgen, Matthias, Wendtner, Clemens Martin, Kreuzer, Karl Anton, Eichhorst, Barbara, Stilgenbauer, Stephan, Hallek, Michael, and Fischer, Kirsten

Abstract

Background: Venetoclax plus obinutuzumab has been established as a fixed-duration treatment regimen for patients with chronic lymphocytic leukaemia. We compared the long-term efficacy after treatment cessation of the combination of venetoclax plus obinutuzumab with chlorambucil plus obinutuzumab in patients with previously untreated chronic lymphocytic leukaemia. Methods: CLL14 is a multicentre, randomised, open-label, phase 3 trial done at 196 sites in 21 countries. Eligible patients were aged 18 years or older, had untreated chronic lymphocytic leukaemia, and coexisting conditions with a cumulative illness rating scale greater than 6, a creatinine clearance of 30–69 mL/min, or both. Patients were randomly assigned (1:1) via a web and voicemail system with allocation concealment and based on a computer-generated randomisation schedule with a block size of six and stratified by Binet stage and geographical region. Patients received either venetoclax plus obinutuzumab (oral venetoclax initiated on day 22 of cycle 1 [28-day cycles], with a 5-week dose ramp-up [20 mg, 50 mg, 100 mg, and 200 mg, then 400 mg daily for 1 week], thereafter continuing at 400 mg daily until completion of cycle 12; combined with intravenous obinutuzumab for six cycles starting with 100 mg on day 1 and 900 mg on day 2 [or 1000 mg on day 1], 1000 mg on days 8 and day 15 of cycle 1, and subsequently 1000 mg on day 1 of cycles 2 through 6) or chlorambucil plus obinutuzumab (oral chlorambucil at 0·5 mg/kg bodyweight on days 1 and 15 of each cycle for 12 cycles combined with the same obinutuzumab regimen). The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. Patient enrolment is complete, and the study is registered with ClinicalTrails.gov, NCT02242942. Findings: Between Aug 7, 2015, and Aug 4, 2016, 432 patients were enrolled and randomly assigned to r

Published
2020

7. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions

Author

Fischer, Kirsten, primary, Al-Sawaf, Othman, additional, Bahlo, Jasmin, additional, Fink, Anna-Maria, additional, Tandon, Maneesh, additional, Dixon, Mark, additional, Robrecht, Sandra, additional, Warburton, Simon, additional, Humphrey, Kathryn, additional, Samoylova, Olga, additional, Liberati, Anna M., additional, Pinilla-Ibarz, Javier, additional, Opat, Stephen, additional, Sivcheva, Liliya, additional, Le Dû, Katell, additional, Fogliatto, Laura M., additional, Niemann, Carsten U., additional, Weinkove, Robert, additional, Robinson, Sue, additional, Kipps, Thomas J., additional, Boettcher, Sebastian, additional, Tausch, Eugen, additional, Humerickhouse, Rod, additional, Eichhorst, Barbara, additional, Wendtner, Clemens-Martin, additional, Langerak, Anton W., additional, Kreuzer, Karl-Anton, additional, Ritgen, Matthias, additional, Goede, Valentin, additional, Stilgenbauer, Stephan, additional, Mobasher, Mehrdad, additional, and Hallek, Michael, additional

Published
2019
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8. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: Results of two phase 3, randomized, placebo-controlled trials

Author

Bussel, James, primary, Arnold, Donald M., additional, Grossbard, Elliot, additional, Mayer, Jiří, additional, Treliński, Jacek, additional, Homenda, Wojciech, additional, Hellmann, Andrzej, additional, Windyga, Jerzy, additional, Sivcheva, Liliya, additional, Khalafallah, Alhossain A., additional, Zaja, Francesco, additional, Cooper, Nichola, additional, Markovtsov, Vadim, additional, Zayed, Hany, additional, and Duliege, Anne-Marie, additional

Published
2018
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9. Final Results from PROUD-PV a Randomized Controlled Phase 3 Trial Comparing Ropeginterferon Alfa-2b to Hydroxyurea in Polycythemia Vera Patients

Author

Gisslinger, Heinz, primary, Klade, Christoph, additional, Georgiev, Pencho, additional, Skotnicki, Aleksander, additional, Gercheva-Kyuchukova, Liana, additional, Egyed, Miklos, additional, Rossiev, Viktor, additional, Dulicek, Petr, additional, Illes, Arpad, additional, Pylypenko, Halyna, additional, Sivcheva, Liliya, additional, Mayer, Jiri, additional, Grohmann-Izay, Barbara, additional, Hasselbalch, Hans, additional, Kralovics, Robert, additional, and Kiladjian, Jean-Jacques, additional

Published
2016
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10. Fostamatinib for the treatment of adult persistent and chronic immune thrombocytopenia: Results of two phase 3, randomized, placebo-controlled trials

Author

Jacek Treliński, Francesco Zaja, Anne-Marie Duliege, James B. Bussel, Liliya Sivcheva, Nichola Cooper, Wojciech Homenda, Alhossain A Khalafallah, Vadim Markovtsov, Donald M. Arnold, Elliot Grossbard, Hany Zayed, Andrzej Hellmann, Jiří Mayer, Jerzy Windyga, Bussel, Jame, Arnold, Donald M., Grossbard, Elliot, Mayer, Jiří, Treliński, Jacek, Homenda, Wojciech, Hellmann, Andrzej, Windyga, Jerzy, Sivcheva, Liliya, Khalafallah, Alhossain A., Zaja, Francesco, Cooper, Nichola, Markovtsov, Vadim, Zayed, Hany, and Duliege, Anne-Marie

Subjects
0301 basic medicine, Adult, Blood Platelets, medicine.medical_specialty, Nausea, Pyridines, medicine.medical_treatment, Morpholines, Splenectomy, Aminopyridines, Placebo, Fostamatinib, Gastroenterology, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, hemic and lymphatic diseases, Oxazines, medicine, Clinical endpoint, SYK, Humans, Syk Kinase, Adverse effect, Research Articles, Purpura, Thrombocytopenic, Idiopathic, business.industry, Platelet Count, Hematology, Treatment, ITP, 030104 developmental biology, Pyrimidines, Treatment Outcome, 030220 oncology & carcinogenesis, Chronic Disease, Rituximab, medicine.symptom, business, medicine.drug, Research Article
Abstract

Spleen tyrosine kinase (Syk) signaling is central to phagocytosis‐based, antibody‐mediated platelet destruction in adults with immune thrombocytopenia (ITP). Fostamatinib, an oral Syk inhibitor, produced sustained on‐treatment responses in a phase 2 ITP study. In two parallel, phase 3, multicenter, randomized, double‐blind, placebo‐controlled trials (FIT1 and FIT2), patients with persistent/chronic ITP were randomized 2:1 to fostamatinib (n = 101) or placebo (n = 49) at 100 mg BID for 24 weeks with a dose increase in nonresponders to 150 mg BID after 4 weeks. The primary endpoint was stable response (platelets ≥50 000/μL at ≥4 of 6 biweekly visits, weeks 14‐24, without rescue therapy). Baseline median platelet count was 16 000/μL; median duration of ITP was 8.5 years. Stable responses occurred in 18% of patients on fostamatinib vs. 2% on placebo (P = .0003). Overall responses (defined retrospectively as ≥1 platelet count ≥50 000/μL within the first 12 weeks on treatment) occurred in 43% of patients on fostamatinib vs. 14% on placebo (P = .0006). Median time to response was 15 days (on 100 mg bid), and 83% responded within 8 weeks. The most common adverse events were diarrhea (31% on fostamatinib vs. 15% on placebo), hypertension (28% vs. 13%), nausea (19% vs. 8%), dizziness (11% vs. 8%), and ALT increase (11% vs. 0%). Most events were mild or moderate and resolved spontaneously or with medical management (antihypertensive, anti‐motility agents). Fostamatinib produced clinically‐meaningful responses in ITP patients including those who failed splenectomy, thrombopoietic agents, and/or rituximab. Fostamatinib is a novel ITP treatment option that targets an important mechanism of ITP pathogenesis.

Published
2018

11. End Point Surrogacy in First-Line Chronic Lymphocytic Leukemia.

Author

Simon F, Ligtvoet R, Robrecht S, Cramer P, Kutsch N, Fürstenau M, Goede V, von Tresckow J, Langerbeins P, Fink AM, Huber H, Tausch E, Schneider C, Wendtner CM, Ritgen M, Dreyling M, Müller L, Jacobasch L, Heinz WJ, Vehling-Kaiser U, Sivcheva L, Böttcher S, Dreger P, Illmer T, Gregor M, Staber PB, Stilgenbauer S, Niemann CU, Kater AP, Fischer K, Eichhorst B, Hallek M, and Al-Sawaf O

Abstract

Purpose: Surrogate end points are commonly used to estimate treatment efficacy in clinical studies of chronic lymphocytic leukemia (CLL). This patient- and trial-level analysis describes the correlation between progression-free survival (PFS) and minimal residual disease (MRD) with overall survival (OS) in first-line trials for CLL., Patients and Methods: First, patient-level correlation was confirmed using source data from 12 frontline German CLL Study Group (GCLLSG)-trials. Additionally, a joint-frailty copula model was fitted to validate correlation in the setting of targeted therapies (TT). Second, a meta-analysis of first-line phase III trials in CLL from 2008 to 2024 was performed. Treatment effect correlation was quantified from seven GCLLSG and nine published trials, using hazard ratios (HRs) for time-to-event and odds ratios for binary end points., Results: The GCLLSG analysis set comprised 4,237 patients. Patient-level correlation for PFS/OS was strong with Spearman Rho >0.9. The joint-frailty copula indicated a weak correlation for chemotherapy/chemoimmunotherapy (C/CIT) with a tau of 0.52 (95% CI, 0.49 to 0.55) while the correlation was strong for TT (tau, 0.91 [95% CI, 0.89 to 0.93). The meta-analysis set contained a total of 8,065 patients including 5,198 (64%) patients treated with C/CIT and 2,867 (36%) treated with TT. Treatment-effect correlation of the HRs for PFS and OS was R = 0.75 (95% CI, 0.74 to 0.76, R 2 = 0.56) while correlation of end-of-treatment MRD with PFS and OS was R = 0.88 (95% CI, -0.87 to 0.89; R 2 = 0.78) and 0.71 (95% CI, 0.69 to 0.73; R 2 = 0.5), respectively., Conclusion: Patient-level correlation was confirmed in the setting of TTs while treatment-effect correlation between PFS and OS remains uncertain. MRD response status showed a high treatment-effect correlation with PFS but not OS, with the caveat of a limited number of randomized trials with available MRD data.

Published
2024
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