RecruitingPhase 2NCT04626024

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

Safety And Efficacy Of Tyrosine Kinase Inhibitor Cessation For Chronic Myeloid Leukemia Patients With Stable Molecular Response In A Real World Population


Sponsor

Baylor College of Medicine

Enrollment

100 participants

Start Date

Dec 22, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, phase II study to evaluate safety and efficacy of tyrosine kinase inhibitor (TKI) cessation for chronic myeloid leukemia (CML) patients with stable molecular response in a real world population.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is exploring whether patients with chronic myeloid leukemia (CML) — a type of blood cancer — who have been in very deep remission for a long time can safely stop taking their targeted therapy (TKI) medication without the cancer returning. This is sometimes called "treatment-free remission." **You may be eligible if...** - You are 18 or older - You have a confirmed diagnosis of CML (Philadelphia chromosome positive) - You have been taking a TKI medication for more than 3 years - Your cancer has been undetectable (MR4.5 level remission) for at least 24 months, confirmed by 3 or more tests - Your blood counts and organ function are within healthy ranges - You are in good general health (able to carry out normal daily activities) **You may NOT be eligible if...** - You have had or are planning a stem cell transplant from a donor - You have HIV or active liver disease - You have had another active cancer - You missed more than 2 weeks of TKI treatment in the past 6 months - You received another experimental treatment in the last 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERImatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Withdrawal

Stop taking TKI medication

DRUGImatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Re-initiation

Re-start TKI medication


Locations(4)

Baylor College of Medicine- McNair Campus

Houston, Texas, United States

Ben Taub General Hospital

Houston, Texas, United States

CHI St. Luke's Health Baylor College of Medicine Medical Center

Houston, Texas, United States

Harris Health System- Smith Clinic

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04626024


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