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SWOG S1712

Trial Overview

Official Title

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

Study Purpose

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.

Diagnosis

Chronic myeloid leukemia (CML) with BCR-ABL in blood.

Eligibility

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.

Intervention

  • 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

Key Participation Requirements
Gender
Male or Female
Age
19 years and older
Phase
Phase II
Methodist Health System Trial Code
S1712
Related Specialties