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.
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.
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Authors: John O Mascarenhas; Raajit K Rampal; Heidi E Kosiorek; Rupali Bhave; Elizabeth Hexner; Eunice S Wang; Aaron Gerds; Camille N Abboud; Marina Kremyanskaya; Dimitry Berenzon; Olatoyosi Odenike; Noushin Farnoud; Aishwarya Krishnan; Rona Singer Weinberg; Erin McGovern; Mohamed E Salama; Vesna Najfeld; Juan S Medina-Martinez; Juan E Arango Ossa; Max F Levine; Yangyu Zhou; Lonette Sandy; Mark L Heaney; Ross L Levine; Ruben A Mesa; Amylou C Dueck; Ronald Hoffman Journal: Blood Adv Date: 2020-10-27