دورية أكاديمية
أعرض في EDS

Phase 2 study of ruxolitinib and decitabine in patients with myeloproliferative neoplasm in accelerated and blast phase.

التفاصيل البيبلوغرافية
العنوان: Phase 2 study of ruxolitinib and decitabine in patients with myeloproliferative neoplasm in accelerated and blast phase.
المؤلفون: Mascarenhas JO; Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY., Rampal RK; Leukemia Service, Department of Medicine.; Center for Hematologic Malignancies, and.; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY., Kosiorek HE; Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ., Bhave R; Wake Forest Baptist Health, Winston-Salem, NC., Hexner E; University of Pennsylvania, Philadelphia, PA., Wang ES; Roswell Park Comprehensive Cancer Center, Buffalo, NY., Gerds A; Leukemia and Myeloid Disorders Program, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH., Abboud CN; Washington University in St. Louis School of Medicine, St. Louis, MO., Kremyanskaya M; Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY., Berenzon D; Wake Forest Baptist Health, Winston-Salem, NC., Odenike O; The University of Chicago Medicine and Comprehensive Cancer Center, Chicago, IL., Farnoud N; Center for Hematologic Malignancies, and.; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY., Krishnan A; Center for Hematologic Malignancies, and.; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY., Weinberg RS; New York Blood Center, New York, NY., McGovern E; Center for Hematologic Malignancies, and.; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY., Salama ME; Department of Pathology, Mayo Clinic, Rochester, MN., Najfeld V; Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY., Medina-Martinez JS; Department of Computational Oncology, Memorial Sloan Kettering Cancer Center, New York, NY., Arango Ossa JE; Department of Computational Oncology, Memorial Sloan Kettering Cancer Center, New York, NY., Levine MF; Department of Computational Oncology, Memorial Sloan Kettering Cancer Center, New York, NY., Zhou Y; Department of Computational Oncology, Memorial Sloan Kettering Cancer Center, New York, NY., Sandy L; Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY., Heaney ML; Department of Medicine, Columbia University Medical Center, New York, NY., Levine RL; Leukemia Service, Department of Medicine.; Center for Hematologic Malignancies, and.; Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY.; Human Oncology and Pathogenesis Program, Memorial Sloan Kettering Cancer Center, New York, NY; and., Mesa RA; Mays Cancer Center at UT Health San Antonio, San Antonio, TX., Dueck AC; Department of Health Sciences Research, Mayo Clinic, Scottsdale, AZ., Hoffman R; Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY.
المصدر: Blood advances [Blood Adv] 2020 Oct 27; Vol. 4 (20), pp. 5246-5256.
نوع المنشور: Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't
اللغة: English
بيانات الدورية: Publisher: American Society of Hematology Country of Publication: United States NLM ID: 101698425 Publication Model: Print Cited Medium: Internet ISSN: 2473-9537 (Electronic) Linking ISSN: 24739529 NLM ISO Abbreviation: Blood Adv Subsets: MEDLINE
أسماء مطبوعة: Original Publication: Washington, DC : American Society of Hematology, [2016]-
مواضيع طبية MeSH: Blast Crisis*/drug therapy , Pyrazoles*/therapeutic use, Decitabine/therapeutic use ; Humans ; Nitriles ; Pyrimidines ; Treatment Outcome
مستخلص: Myeloproliferative neoplasms (MPN) that have evolved into accelerated or blast phase disease (MPN-AP/BP) have poor outcomes with limited treatment options and therefore represent an urgent unmet need. We have previously demonstrated in a multicenter, phase 1 trial conducted through the Myeloproliferative Neoplasms Research Consortium that the combination of ruxolitinib and decitabine is safe and tolerable and is associated with a favorable overall survival (OS). In this phase 2 trial, 25 patients with MPN-AP/BP were treated at the recommended phase 2 dose of ruxolitinib 25 mg twice daily for the induction cycle followed by 10 mg twice daily for subsequent cycles in combination with decitabine 20 mg/m2 for 5 consecutive days in a 28-day cycle. Nineteen patients died during the study follow-up. The median OS for all patients on study was 9.5 months (95% confidence interval, 4.3-12.0). Overall response rate (complete remission + incomplete platelet recovery + partial remission) was 11/25 (44%) and response was not associated with improved survival. We conclude that the combination of decitabine and ruxolitinib was well tolerated, demonstrated favorable OS, and represents a therapeutic option for this high-risk patient population. This trial was registered at www.clinicaltrials.gov as #NCT02076191.
(© 2020 by The American Society of Hematology.)
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معلومات مُعتمدة: K08 CA188529 United States CA NCI NIH HHS; P01 CA108671 United States CA NCI NIH HHS; P30 CA008748 United States CA NCI NIH HHS
سلسلة جزيئية: ClinicalTrials.gov NCT02076191
المشرفين على المادة: 0 (Nitriles)
0 (Pyrazoles)
0 (Pyrimidines)
776B62CQ27 (Decitabine)
82S8X8XX8H (ruxolitinib)
تواريخ الأحداث: Date Created: 20201026 Date Completed: 20210514 Latest Revision: 20211204
رمز التحديث: 20240628
مُعرف محوري في PubMed: PMC7594401
DOI: 10.1182/bloodadvances.2020002119
PMID: 33104796
قاعدة البيانات: MEDLINE
الوصف
تدمد:2473-9537
DOI:10.1182/bloodadvances.2020002119