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CML TKI Cessation Study

This study is looking at whether it's safe and effective for people with Chronic Myeloid Leukemia (CML) to stop taking their tyrosine kinase inhibitor (TKI) medications (Imatinib Mesylate, Dasatinib, Nilotinib, or Bosutinib). You might be able to join if you are 18 or older, have CML that is Philadelphia chromosome- or BCR-ABL1-positive, have been taking a TKI for over 36 months, and have a history of a stable molecular response (MR4). The main goal is to see how many people can stop their TKI without their CML returning, specifically looking at molecular relapse (when the disease starts to show up again at a molecular level) up to 6 months after stopping the medication. If your CML does return, you would restart your TKI medication.

Study design
This is a single-arm study, meaning all participants receive the same intervention. It aims to enroll 17 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for molecular relapse up to 6 months after stopping their TKI medication.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04626024

Safety And Efficacy Of TKI Cessation For CML Patients With Stable Molecular Response In A Real World Population

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
Baylor College of Medicine
~17 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib WithdrawalImatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Re-initiation

At a glance

Recruiting sites
0 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Molecular relapse (MR) free survival
Measured over From date of TKI cessation to the date of MR or censoring, assessed up to 6 months

Conditions

Chronic Myeloid Leukemia
Chronic Myeloid Leukemia, BCR/ABL-Positive, in Remission
Chronic Myeloid Leukemia in Remission

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Where it's being run

4 sites across 1 states
Texas4

Study leadership

  • Martha P. Mims, MD, PhD · PRINCIPAL_INVESTIGATOR · Baylor College of Medicine

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute Neutrophil Count (ANC) ≥ 1.5 x 10E9/L
Hemoglobin ≥ 9.0 g/dL
Platelets ≥ 100 x 10E9/L 9. Patients must not have any signs of extramedullary leukemia 10. Patients must have a life expectancy of more than 12 months in the absence of any intervention 11. All participants must be informed of the investigational nature of this study and must sign and give written informed consent 12. Contraception requirements will be as per routine clinical practice.

What this trial measures

  • Molecular relapse (MR) free survivalFrom date of TKI cessation to the date of MR or censoring, assessed up to 6 months

    The Kaplan-Meier method will be used to estimate MR free survival rate at 6 months after TKI cessation with a 95% confidence interval.