drugset / Trial / NCT01787487
Ruxolitinib Phosphate and Azacytidine in Treating Patients With Myelofibrosis or Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Non-randomizedParallel-groupOpen-labelTreatment
Summary
This phase II trial studies how well ruxolitinib phosphate and azacytidine work in treating patients with myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacytidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ruxolitinib phosphate and azacytidine may be an effective treatment for myelofibrosis or myelodysplastic syndrome/myeloproliferative neoplasm.
Timeline
- Start
- 2013-03-13
- Primary completion
- 2026-01-20
- Completion
- 2026-01-20
Publications
- Arora S, Senapati J, Deshmukh I, Bose P, Masarova L, Loghavi S, Wang X, Nogueras-Gonzalez G, Montalban-Bravo G, Borthakur G, DiNardo CD, Kadia T, Zhou L, Saenz D, Halim H, Alvarado Y, Ohanian M, Takahashi K, Short NJ, Jabbour E, Ravandi F, Garcia-Manero G, Pemmaraju N, Daver NG. Final analysis of phase 2 clinical trial of ruxolitinib and azacitidine combination therapy in patients with myelodysplastic syndrome/myeloproliferative neoplasms. J Hematol Oncol. 2026 Jun 16. doi: 10.1186/s13045-026-01813-7. Online ahead of print.
- Masarova L, Verstovsek S, Hidalgo-Lopez JE, Pemmaraju N, Bose P, Estrov Z, Jabbour EJ, Ravandi-Kashani F, Takahashi K, Cortes JE, Ning J, Ohanian M, Alvarado Y, Zhou L, Pierce S, Gergis R, Patel KP, Luthra R, Kadia TM, DiNardo CD, Borthakur G, Bhalla K, Garcia-Manero G, Bueso-Ramos CE, Kantarjian HM, Daver N. A phase 2 study of ruxolitinib in combination with azacitidine in patients with myelofibrosis. Blood. 2018 Oct 18;132(16):1664-1674. doi: 10.1182/blood-2018-04-846626. Epub 2018 Sep 5.
- Assi R, Kantarjian HM, Garcia-Manero G, Cortes JE, Pemmaraju N, Wang X, Nogueras-Gonzalez G, Jabbour E, Bose P, Kadia T, Dinardo CD, Patel K, Bueso-Ramos C, Zhou L, Pierce S, Gergis R, Tuttle C, Borthakur G, Estrov Z, Luthra R, Hidalgo-Lopez J, Verstovsek S, Daver N. A phase II trial of ruxolitinib in combination with azacytidine in myelodysplastic syndrome/myeloproliferative neoplasms. Am J Hematol. 2018 Feb;93(2):277-285. doi: 10.1002/ajh.24972. Epub 2017 Nov 27.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Azacitidine | Other / unclassified | 25 mg/m2 | Subcutaneous |
| Subject | Azacitidine | Other / unclassified | 75 mg/m2 | Subcutaneous |
| Subject | Ruxolitinib | Small molecule | — | Oral |