A phase I/II study of the Janus kinase (JAK)1 and 2 inhibitor ruxolitinib in patients with relapsed or refractory acute myeloid leukemia

Naveen Pemmaraju, Hagop Kantarjian, Tapan Kadia, Jorge Cortes, Gautam Borthakur, Kate Newberry, Guillermo Garcia-Manero, Farhad Ravandi, Elias Jabbour, Sara Dellasala, Sherry Pierce, Srdan Verstovsek

Research output: Contribution to journalArticlepeer-review

45 Scopus citations

Abstract

Background Ruxolitinib is a potent and specific JAK1/JAK2 inhibitor recently approved for the treatment of myelofibrosis. Patients and Methods We conducted a single-center phase I/II clinical study testing 3 dose levels (50 mg b.i.d. [n = 4], 100 mg b.i.d. [n = 5], and 200 mg b.i.d. [n = 18]). We enrolled 27 patients older than 14 years with relapsed or refractory acute myeloid leukemia (n = 26) or acute lymphoid leukemia (n = 1). Results The median age was 66 (range, 25-88) years. Thirteen patients were evaluable for dose-limiting toxicities. The most common Grade 3 or 4 nonhematologic event was infection (n = 26 events; most frequently pneumonia; 15 of 26; 58%). One patient with multiple relapses after 7 lines of therapy had a CRp at a ruxolitinib dose of 200 mg b.i.d. Conclusion In this cohort of heavily pretreated patients with relapsed or refractory acute leukemias, ruxolitinib was overall reasonably well tolerated, with 1 patient achieving CRp.

Original languageEnglish (US)
Pages (from-to)171-176
Number of pages6
JournalClinical Lymphoma, Myeloma and Leukemia
Volume15
Issue number3
DOIs
StatePublished - Mar 1 2015
Externally publishedYes

Keywords

  • Acute myelogenous leukemia
  • Clinical study
  • JAK2V617 mutation
  • Janus kinase inhibitor
  • Myelofibrosis
  • Ruxolitinib

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research

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