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