Ruxolitinib for CML with minimal residual disease [USA]

Study title

Ruxolitinib for Chronic Myeloid Leukemia (CML) with Minimal Residual Disease (MRD)

Scientific title

Phase I-II Study of Ruxolitinib (INCB18424) for Patients With Chronic Myeloid Leukemia (CML) With Minimal Residual Disease While on Therapy With Tyrosine Kinase Inhibitors

Type of study

Therapy optimization trial

Current status

Active, not recruiting

What is the purpose of the study

This study consists of two parts. The goal of the first part is to find the highest tolerable dose of ruxolitinib that can be given with a tyrosine kinase inhibitor that patients are already taking as part of their standard treatment. The goal of the second part of this study is to learn if this drug combination can help to control CML in patients in whom, despite a good response to therapy, the disease is still detectable at low levels (this is called “minimal residual disease”). Researchers believe that eliminating all detectable evidence of disease may decrease the chances that the leukemia will ever come back. The safety of the drug combination will also be studied in both parts.

Key inclusion criteria

Potential study participants must be 18 years or older and have Philadelphia chromosome (Ph)-positive or BCR/ABL-positive CML. They have been receiving imatinib (once the maximum tolerated dose (MTD) has been established, patients receiving dasatinib or nilotinib also eligible) for at least 18 months with no increase in their dose for the last 6 months.

Patients with some response to tyrosine kinase inhibitor (TKI) but persistent minimal residual disease are eligible. In the phase 1 portion of the study only patients receiving imatinib who have at least a complete hematologic response are eligible. Once MTD is determined, patients with nilotinib or dasatinib are also eligible. For the phase 2 portion of the study only patients with complete cytogenetic response are eligible provided they have detectable disease.

Key exclusion criteria

Where can I find additional information

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

Study sponsor

M.D. Anderson Cancer Center
In collaboration with
Incyte Corporation

Scientific lead / contact

Jorge Cortes, MD

Principal investigator

Jorge Cortes, MD

Study centers / principal investigators

United States

UT MD Anderson Cancer Center
Houston, Texas, 77030
Jorge Cortes, MD