Dataset Information
A phase I/II study of the Janus kinase (JAK)1 and 2 inhibitor ruxolitinib in patients with relapsed or refractory acute myeloid leukemia.
Ontology highlight
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.
SUBMITTER: Pemmaraju N
PROVIDER: S-EPMC4344906 | biostudies-literature | 2015 Mar
REPOSITORIES: biostudies-literature
Publications
A phase I/II study of the Janus kinase (JAK)1 and 2 inhibitor ruxolitinib in patients with relapsed or refractory acute myeloid leukemia.
Clinical lymphoma, myeloma & leukemia 20140917 3
<h4>Background</h4>Ruxolitinib is a potent and specific JAK1/JAK2 inhibitor recently approved for the treatment of myelofibrosis.<h4>Patients and methods</h4>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).<h4>Results</h4>The median age was 66 (range, 25-88 ...[more]