S1712 = Addition of Ruxolitinib to the Usual Treatment (Tyrosine Kinase Inhibitors) for CML [USA]
Type of study
Trials that are no longer recruiting
Phase
Current status
Active, no longer recruiting
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)
Other trial ID
NCI-2017-02066, Clinicaltrials.gov NCT03654768
What is the purpose of the study
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 sponsor
Southwest Oncology Group
National Cancer Institute (NCI)
Portland, Oregon, USA
Scientific lead / contact
Kendra L. Sweet, MD
Principal investigator
Kendra L. Sweet, MD
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