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
Chronic Myeloid Leukemia
also called: Chronic Myelogeneous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
Inclusion criteria
Inlusion criteria define which subjects may participate in a clinical study. Study subjects must fulfill all inclusion criteria (e.g. with regard to sex, age, previous diseases). This ensures a uniform composition of the study population and minimizes the risk of influences that distort the study results.
Chronic phase
The earliest phase of CML development.
Randomization
In a clinical trial, patients are assigned by chance (often by a computer) to receive either one or the other treatment. This is to avoid bias in recruiting patients with specific characteristics into single arms of a trial.
Indication
In medicine, a reason to use a certain diagnostic test, therapeutic procedure or medication. The opposite of indication is contraindication.
Dasatinib
Trade name: Sprycel, development name: BMS-354825, inhibits BCR-ABL and SRC tyrosine kinases. Authorized for marketing in the EU since 2006 for the treatment of CML and Ph+ALL.
Other names: BMS-354825|BMS354825|Sprycel
Nilotinib
Trade name: Tasigna, development name: AMN107, inhibits BCR-ABL tyrosine kinase. Authorized for marketing in the EU since 2007 for the treatment of CML and Ph+ALL.
Other names: |AMN107|Tasigna
BCR-ABL
The abnormal gene that characterizes Chronic Myeloid Leukemia, which is a fusion of the BCR gene of chromosome 9 and the ABL gene of chromosome 22
Chronic
Long-lasting, slowly developping
Blast
An immature white blood cell that normally represents an early phase of the development process of a blood stem cell in the bone marrow
TKIs
Tyrosine Kinase Inhibitors, a class of drugs that block an enzyme involved in the mechanism of division of cells
CML
Chronic Myeloid Leukemia, also called Chronic Myelogenous Leukemia
A chronic disease of the blood and bone marrow that results from a transformation of a stem cell.
CHR
Abbreviation for Complete Hematologic Response. The blood cell count has returned to normal, and tests don’t show any immature white blood cells. Also, the spleen has returned to a normal size if it was enlarged.
