TOKIN = TKI cessation for CML patients with stable molecular response in a real world population [USA]
Type of study
Treatment discontinuation trial
Current status
Recruiting
Study title
TOKIN = Efficacy and safety of TKI cessation for CML patients with stable molecular response in a real world population
Scientific title
Safety And Efficacy Of Tyrosine Kinase Inhibitor Cessation For Chronic Myeloid Leukemia Patients With Stable Molecular Response In A Real World Population (ClinicalTrials.gov NCT04626024)
What is the purpose of the study
This study will evaluate the safety and efficacy of stopping treatment with a TKI (imatinib, dasatinib, nilotinib or bosutinib) in patients with CML in stable molecular remission in a real world population. Treatment with TKI is discontinued within 7 days of study registration. Patients have a BCR-ABL1 test every month for 24 months.
What will happen during the study
Key inclusion criteria
This study includes male or female patients 18 years and older with Ph1-positive and/or BCR-ABL1-positive CML with evidence of a quantifiable BCR-ABL1 transcript in real time polymerase chain reaction (RT-PCR) tests.
Patients who have been taking a tyrosine kinase inhibitor (TKI) for more than 36 months can be considered for inclusion .
Eligible patients have been in stable complete molecular remission (MR4.5) or better for at least 2 years, as documented by at least 3 separate tests performed at least 3 months apart.
Additional criteria may apply.
Key exclusion criteria
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
Baylor College of Medicine
Scientific lead / contact
Martha Mims, MD, PhD,
Baylor College of Medicine,
Houston, Texas
Principal investigator
Martha Mims, MD, PhD,
Baylor College of Medicine,
Houston, Texas
Study centers / principal investigators
United States
Texas
Baylor College of Medicine
Martha Mims, MD, PhD,
Houston, Texas, 77030
Ben Taub General Hospital
Martha Mims, MD, PhD
Houston, Texas, 77030
CHI St. Luke’s Health Baylor College of Medicine Medical Center
Martha Mims, MD, PhD
Houston, Texas, 77030
Harris Health System- Smith Clinic
Martha Mims, MD, PhD
Houston, Texas, 77054