Phase 2 study of ruxolitinib and decitabine in patients with myeloproliferative neoplasm in accelerated and blast phase Journal Article
| Authors: | Mascarenhas, J. O.; Rampal, R. K.; Kosiorek, H. E.; Bhave, R.; Hexner, E.; Wang, E. S.; Gerds, A.; Abboud, C. N.; Kremyanskaya, M.; Berenzon, D.; Odenike, O.; Farnoud, N.; Krishnan, A.; Singer Weinberg, R.; McGovern, E.; Salama, M. E.; Najfeld, V.; Medina-Martinez, J. S.; Arango Ossa, J. E.; Levine, M. F.; Zhou, Y.; Sandy, L.; Heaney, M. L.; Levine, R. L.; Mesa, R. A.; Dueck, A. C.; Hoffman, R. |
| Article Title: | Phase 2 study of ruxolitinib and decitabine in patients with myeloproliferative neoplasm in accelerated and blast phase |
| Abstract: | 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 1 incomplete platelet recovery 1 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 |
| Journal Title: | Blood Advances |
| Volume: | 4 |
| Issue: | 20 |
| ISSN: | 2473-9529 |
| Publisher: | American Society of Hematology |
| Date Published: | 2020-10-27 |
| Start Page: | 5246 |
| End Page: | 5256 |
| Language: | English |
| DOI: | 10.1182/bloodadvances.2020002119 |
| PUBMED: | 33104796 |
| PROVIDER: | scopus |
| PMCID: | PMC7594401 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 4 January 2021 -- Source: Scopus |
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