Ruxolitinib (INCB018424) in Participants With Primary Myelofibrosis (PMF), Post Essential Thrombocythemia-myelofibrosis and Post Polycythemia Vera-myelofibrosis (PPV-MF)
Summary
To evaluate the effects of treatment with ruxolitinib (INCB018424) on spleen volume, symptoms and potential side effects in participants with PMF, PPV-MF and PET-MF who have platelet counts of 50 x 10\^9/L to 100 x 10\^9/L. It is anticipated that individualized dose optimization from the starting ruxolitinib level of 5 mg bid will be associated with reductions in splenomegaly, MF-associated symptoms and inflammatory cytokine levels.
Timeline
- Start
- 2011-06-15
- Primary completion
- 2018-12-19
- Completion
- 2018-12-19
Outcome
Mixed primary results
registry MEAN 10 mg BID: -22.4 (Standard Deviation 22.86) Percentage change from baseline NCT01348490 ↗
registry analysis (other test); 10 mg BID; p <0.0001; t-test, 1 sided; note: 1-sample t-test was used. NCT01348490 ↗
registry MEAN 10 mg AM/ 15 mg PM or 15 mg BID: -13.4 (Standard Deviation 22.29) Percentage change from baseline NCT01348490 ↗
registry analysis (other test); 10 mg AM/ 15 mg PM or 15 mg BID; p = 0.2019; t-test, 1 sided; note: 1-sample t-test was used. NCT01348490 ↗
registry MEAN 10 mg BID: -47.54 (Standard Deviation 46.886) Percentage change from baseline NCT01348490 ↗
registry MEAN 5 mg QD or 5 mg BID: -6.35 (Standard Deviation 64.207) Percentage change from baseline NCT01348490 ↗
registry analysis (other test); 5 mg QD or 5 mg BID; p = 0.6887; t-test, 1 sided; note: 1-sample t-test was used. NCT01348490 ↗
Publications
- Talpaz M, Prchal J, Afrin L, Arcasoy M, Hamburg S, Clark J, Kornacki D, Colucci P, Verstovsek S. Safety and Efficacy of Ruxolitinib in Patients with Myelofibrosis and Low Platelet Counts (50 - 100 x 109/L): Final Analysis of an Open-Label Phase 2 Study. Clin Lymphoma Myeloma Leuk. 2022 May;22(5):336-346. doi: 10.1016/j.clml.2021.10.016. Epub 2021 Nov 2.
- Talpaz M, Paquette R, Afrin L, Hamburg SI, Prchal JT, Jamieson K, Terebelo HR, Ortega GL, Lyons RM, Tiu RV, Winton EF, Natrajan K, Odenike O, Claxton D, Peng W, O'Neill P, Erickson-Viitanen S, Leopold L, Sandor V, Levy RS, Kantarjian HM, Verstovsek S. Interim analysis of safety and efficacy of ruxolitinib in patients with myelofibrosis and low platelet counts. J Hematol Oncol. 2013 Oct 29;6(1):81. doi: 10.1186/1756-8722-6-81.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ruxolitinib | Small molecule | 5 mg | Oral |