A randomized phase II study of ruxolitinib (NCS-752295) in combination with BCR-ABL tyrosine kinase inhibitors in chronic myeloid leukemia (CML) patients with molecular evidence of disease
The purpose of this study is to compare the good and bad effects of adding the study drug ruxolitinib to the usual chemotherapy (called TKI, which is either dasatinib or nilotinib) with the good and bad effects of using TKI alone.
DiagnosisChronic myeloid leukemia (CML) with BCR-ABL in blood.
Patients must be receiving treatment with dasatinib or nilotinib as first or second line therapy for a minimum of 6 months prior to registration.
Patients must not be receiving any other investigational agents.
Patients must sign an approved informed consent and authorization permitting release of personal health information.
- ARM I: Receive single agent TKI for up to one year
- ARM II: Receive single agent TKI and ruxolitinib for up to one year
Patients will be followed for up to 5 years from initial randomization.
For more information, visit ClinicalTrials.gov