S1712 = Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for CML [USA]
Study title
Testing the Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for Chronic Myeloid Leukemia (S1712)
Scientific title
A Randomized Phase II Study of Ruxolitinib (NSC-752295) in Combination With BCR-ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) (clinicaltrials.gov NCI-2017-02066; NCT03654768)
Indication and most important inclusion criteria
This study includes patients 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 been receiving treatment with dasatinib or nilotinib as first or second line therapy for a minimum of 6 months prior to registration
- have not received more than 2 tyrosine kinase inhibitors (TKIs) for treatment of CML (hydroxyurea prior to initiation of TKI is allowed)
- have been on their current TKI for a minimum of 6 months prior to randomization
- are expected to remain on the same TKI for the next 12 months
- have adequate liver and kidney function
Other criteria may apply. Please consult your doctor for further details.
Short description of intervention
This study assesses how well ruxolitinib phosphate and dasatinib or nilotinib work in treating patients with chronic myeloid leukemia. Ruxolitinib, dasatinib, and nilotinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Type of study
Therapy optimization trial
Current status
Recruiting
Study sponsor
Southwest Oncology Group
National Cancer Institute (NCI)
Portland, Oregon, USA
Scientific lead / contact
Kendra L. Sweet, MD
Principal investigator
Kendra L. Sweet, MD
Additional information
Study centers / principal investigators
United States
Southwest Oncology Group
National Cancer Institute (NCI)
Kendra L. Sweet, MD
Portland, Oregon 97239
For details on 517 study locations see study information at clinicaltrials.gov