S1712 = Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for CML [USA]

What is the purpose of the study

This study assesses how well ruxolitinib phosphate and bosutinib, dasatinib, imatinib or nilotinib work in treating patients with CML.

What will happen during the study

Patients will be randomly assigned to one of two treatment arms.

Participants in Arm 1 will receive

• bosutinib orally once daily or
• dasatinib orally once daily or
• nilotinib orally twice daily or
• imatinib orally once daily on days 1-90.

Treatment repeats every 90 days for up to 4 cycles unless the disease progresses or unacceptable toxicity occurs.

Participants in Arm 2 will receive ruxolitinib phosphate orally twice daily on days 1-90, and

• bosutinib orally once daily or
• dasatinib orally once daily or
• nilotinib orally twice daily or
• imatinib orally  once daily on days 1-90.

Treatment repeats every 90 days for up to 4 cycles unless the disease progresses or unacceptable toxicity occurs.

Key inclusion criteria

This study includes patients of all sexes who:

• are at least 18 years old
• have been diagnosed with chronic phase chronic myeloid leukemia (CML-CP) without any history of progression to accelerated or blast phase CML
• have BCR-ABL transcript levels >0.0032% and ≤1.0% on the international scale (IS) within 21 days prior to randomization
• have been receiving treatment with a TKI for CML for at least 12 months prior to to randomization. Hydoxyurea prior to initiation of TKI is allowed.
• are currently receiving treatment with bosutinib, nilotinib, dasatinib, or imatinib; they must have received their current TKI for at least 6 months prior to randomization and must be expected to remain on the same TKI for the next 12 months
• have adequate liver and kidney function.

Key exclusion criteria

This study does not include patients who:

• have a history of resistance to any prior TKI drug
• are receiving any other investigational agents.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

United States

Southwest Oncology Group
National Cancer Institute (NCI)
Kendra L. Sweet, MD
Portland, Oregon 97239

For details on 541 study locations see study information at clinicaltrials.gov