Leukemia, Lymphocytic, Chronic, B-Cell Clinical Trial
Official title:
A Phase I/II Trial of Ruxolitinib in Chronic Lymphocytic Leukemia Patients at Risk for Progression on Ibrutinib
This study involves adding the kinase inhibitor Ruxolitinib to Ibrutinib to treat Chronic Lymphocytic Leukemia (CLL).
Ibrutinib is an effective drug that can extend the lives of CLL patients but it is not
curative as a single agent and may eventually select for more aggressive disease. Survival
of CLL cells in the presence of Ibrutinib may be enabled by signals from the
microenvironment where the leukemia cells originate. These signals are transmitted into the
cells by Janus Kinases (JAKs) such as janus kinase 1 (JAK1) and janus kinase 2 (JAK2).
According, JAK inhibitors may overcome the cytoprotective properties of the CLL
microenvironment and help to improve outcomes with Ibrutinib.
The JAK2 inhibitor Ruxolitinib is licensed for use in myelofibrosis and polycythemia rubra
vera and its toxicity and efficacy as a single agent in CLL has been studied in two previous
clinical trials. As a single agent, Ruxolitinib was inferior to Ibrutinib. However,
Ruxolitinib was shown to cooperate with Ibrutinib and increase killing of CLL cells in
vitro. Based on these observations, it is hypothesized that Ruxolitinib will significantly
improve the therapeutic efficacy of single-agent Ibrutinib.
This is a single center phase I/II trial to determine the efficacy and safety of ruxolitinib
tablets in CLL patients being treated until progression with Ibrutinib and considered at
risk to progress on the basis of persistent lymphocytosis and lymphadenopathy after 1 year
of Ibrutinib or elevated beta-2-microglobulin (b2M) levels after 6 months of Ibrutinib.
Ruxolitinib will be administered for 21 days of a 35-day cycle to be repeated 6 more times.
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