Final results of a phase II study of the combination of azacitidine and ruxolitinib in patients with myelofibrosis

Monotherapy with JAK2 inhibitors reduces splenomegaly and symptom burden but has limited effect on natural progression of myelofibrosis. We conducted a phase 2 clinical trial evaluating the combination of azacitidine (AZA) and ruxolitinib (RUX) in myelofibrosis. The interim analysis with 46 patients (median follow-up 28 months) demonstrated a response rate of 72%. We now report the final results of this clinical trial. The study primary endpoint was objective response rate by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. From 3/2013 to 10/2021, 61 patients were treated (median age 66 years; range, 46-87 years). By baseline blast count, 54 patients had chronic phase disease (.

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Publication Details

Journal
Haematologica
Published
2026-08-27
DOI
https://doi.org/10.3324/haematol.2026.301178
Primary Topic
Myeloproliferative Neoplasms: Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
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article

Final results of a phase II study of the combination of azacitidine and ruxolitinib in patients with myelofibrosis

Prithviraj Bose, Linghsa Zhou, Sankalp Arora, Jayastu Senapati et al.
Haematologica
Myeloproliferative Neoplasms: Diagnosis and Treatment
article

Final results of a phase II study of the combination of azacitidine and ruxolitinib in patients with myelofibrosis

Prithviraj Bose, Linghsa Zhou, Sankalp Arora, Jayastu Senapati, Lucia Masárová, Habiba Halim, Victoria Chu, Yesid Alvarado, Maro Ohanian, Dyana Saenz, Tapan Kadia, Farhad Ravandi, Guillermo Garcia-Manero, Naval G. Daver, Elias Jabbour, Hagop Kantarjian, Nitin Jain, Courtney DiNardo, Koichi Takahashi, Naveen Pemmaraju, Jing Ning
article en

Abstract

Monotherapy with JAK2 inhibitors reduces splenomegaly and symptom burden but has limited effect on natural progression of myelofibrosis. We conducted a phase 2 clinical trial evaluating the combination of azacitidine (AZA) and ruxolitinib (RUX) in myelofibrosis. The interim analysis with 46 patients (median follow-up 28 months) demonstrated a response rate of 72%. We now report the final results of this clinical trial. The study primary endpoint was objective response rate by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) criteria. From 3/2013 to 10/2021, 61 patients were treated (median age 66 years; range, 46-87 years). By baseline blast count, 54 patients had chronic phase disease (.

Haematologica
The University of Texas MD Anderson Cancer Center (US), Leukemia Research Foundation (US), The University of Texas Health Science Center (US), The University of Texas Health Science Center at Houston (US)
U.S. Department of Defense, American Society of Clinical Oncology, CareDx, Incyte, MorphoSys, Aptitude Health, National Institutes of Health, University of Texas MD Anderson Cancer Center, National Cancer Institute
Partnerships for the goals
Openalex Percentile: Top 11%
Myeloproliferative Neoplasms: Diagnosis and Treatment
DOIOpen Access PDFOpenAlex
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