CML ADVOCATES NETWORK

Clinical Trials

TOKIN = TKI cessation for CML patients with stable molecular response in a real world population [USA]

Type of study

Treatment discontinuation trial

Phase

2

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

Other trial ID

ClinicalTrials.gov NCT04626024

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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.

What will happen during the study

Patients discontinue their treatment with a TKI within 7 days of study registration. Patients undergo a BCR-ABL1 test every month for 24 months.

Key inclusion criteria

This study includes male or female patients who:

  • are aged 18 years or older
  • have been diagnosed with Philadelphia chromosome- or BCR-ABL1-positive CML, as determined by specific tests called cytogenetics, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR)
  • have evidence of a quantifiable BCR-ABL1 transcript in real time polymerase chain reaction (RT-PCR) tests
  • have been taking a tyrosine kinase inhibitor (TKI) for more than 36 months
  • have been in stable molecular response, defined as MR4.5 for at least 24 months, as documented by 3 or more separate tests performed at least three months apart
  • have a current status of complete molecular remission (CMR), defined as MR4.5, within 30 days of signing consent.

Further criteria may apply. Please discuss these with your doctor or study staff.

Key exclusion criteria

This study does not include patients who:

  • previously underwent or planned allogeneic stem cell transplantation
  • have conditions or treatments that are able to enhance the potential relapse risk after stopping imatinib
  • have received an investigational agent within the last 2 years
  • have an atypical BCR-ABL transcript that cannot be quantified by standard RQ-PCR.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

November 2023

Where can I find additional information

You can find a study description in the US register ClinicalTrials.gov. This is a database provided by 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