Phase l/II Study of Ruxolitinib for Acute Leukemia

NCT01251965 ↗

Phase 1/2 Terminated 27 enrolled M.D. Anderson Cancer Center Incyte Corporation · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to find the highest tolerable dose of ruxolitinib that can be given to patients with acute leukemia and to learn if the study drug can help control the disease. The safety of the drug will also be studied.

Timeline

Start: 2010-12
Primary completion: 2012-07
Completion: 2012-07

Outcome

Outcome not reported

Stopped: “Study was stopped by the principal investigator due to nonsatisfactory clinical benefit even in patients treated at the highest dose (200 mg ).”

Publications

Pemmaraju N, Kantarjian H, Kadia T, Cortes J, Borthakur G, Newberry K, Garcia-Manero G, Ravandi F, Jabbour E, Dellasala S, Pierce S, Verstovsek S. A phase I/II study of the Janus kinase (JAK)1 and 2 inhibitor ruxolitinib in patients with relapsed or refractory acute myeloid leukemia. Clin Lymphoma Myeloma Leuk. 2015 Mar;15(3):171-6. doi: 10.1016/j.clml.2014.08.003. Epub 2014 Sep 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ruxolitinib	Small molecule	50 mg	Oral
Subject	Ruxolitinib	Small molecule	100 mg	Oral
Subject	Ruxolitinib	Small molecule	200 mg	Oral