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NCT01787487
Ruxolitinib Phosphate and Azacytidine in Treating Patients With Myelofibrosis or Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Phase 2 trial testing Azacitidine in Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable in 121 participants. Completed in 20 January 2026.
20 January 2026
Quick facts
| Lead sponsor | M.D. Anderson Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 121 |
| Start date | 13 March 2013 |
| Primary completion | 20 January 2026 |
| Estimated completion | 20 January 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Azacitidine (azacitidine) — full drug profile →
- Laboratory Biomarker Analysis — full drug profile →
- Ruxolitinib Phosphate — full drug profile →
Conditions studied
- Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable — all drugs for Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable →
- Myelofibrosis Transformation in Essential Thrombocythemia — all drugs for Myelofibrosis Transformation in Essential Thrombocythemia →
- Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase — all drugs for Polycythemia Vera, Post-Polycythemic Myelofibrosis Phase →
- Primary Myelofibrosis — all drugs for Primary Myelofibrosis →
Sponsor
M.D. Anderson Cancer Center — full company profile →
Who can join
18 and older, any sex, with Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable or Myelofibrosis Transformation in Essential Thrombocythemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Targeting epigenetic regulators for cancer therapy: mechanisms and advances in clinical trials.
Cheng Y, He C, Wang M, Ma X, et al · · 2019 · cited 760× · PMID 31871779 · DOI 10.1038/s41392-019-0095-0 -
Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x -
JAK-STAT signaling in human disease: From genetic syndromes to clinical inhibition.
Luo Y, Alexander M, Gadina M, O'Shea JJ, et al · · 2021 · cited 92× · PMID 34625141 · DOI 10.1016/j.jaci.2021.08.004 -
Molecular pathogenesis of the myeloproliferative neoplasms.
Greenfield G, McMullin MF, Mills K. · · 2021 · cited 83× · PMID 34193229 · DOI 10.1186/s13045-021-01116-z -
JAK2 inhibitors for myeloproliferative neoplasms: what is next?
Bose P, Verstovsek S. · · 2017 · cited 78× · PMID 28500170 · DOI 10.1182/blood-2017-04-742288 -
Management of myelofibrosis after ruxolitinib failure.
Harrison CN, Schaap N, Mesa RA. · · 2020 · cited 70× · PMID 32198525 · DOI 10.1007/s00277-020-04002-9 -
Therapeutic benefit of decitabine, a hypomethylating agent, in patients with high-risk primary myelofibrosis and myeloproliferative neoplasm in accelerated or blastic/acute myeloid leukemia phase.
Badar T, Kantarjian HM, Ravandi F, Jabbour E, et al · · 2015 · cited 67× · PMID 26183878 · DOI 10.1016/j.leukres.2015.06.001 -
A phase 2 study of ruxolitinib in combination with azacitidine in patients with myelofibrosis.
Masarova L, Verstovsek S, Hidalgo-Lopez JE, Pemmaraju N, et al · · 2018 · cited 61× · PMID 30185431 · DOI 10.1182/blood-2018-04-846626
Verify or expand the search:
- PubMed search for NCT01787487
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01787487 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
- Last refreshed: 31 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01787487.
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