RecruitingNCT05341050

A Study on the Withdrawal of Second-generation Tyrosine Kinase Inhibitors After Dose Reduction in Patients With CML

This Study is a Multicenter, Single-arm, Prospective Study to Evaluate the Efficacy and Safety of Drug Discontinuation After Dose Reduction in Ph+CML-CP Patients Threated With 2G-TKI.


Sponsor

xuna

Enrollment

260 participants

Start Date

Apr 1, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

patients with Ph+ CML-CP who have been treated with second-generation TKIs (nilotinib, dasatinib) for at least 3 years and maintains MMR for at least 2 years, continue to be treated with halved dose for 12 months, and then stop for 12 months.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether patients with chronic myeloid leukemia (CML) can safely stop their medication after gradually reducing the dose. Patients who have been on second-generation tyrosine kinase inhibitors (nilotinib or dasatinib) for at least 3 years and have maintained a deep molecular response for at least 2 years will try taking a half dose for 12 months, then stopping completely for another 12 months. Adults (18+) diagnosed with CML who meet the response criteria are eligible, though those with certain heart conditions, prior stem cell transplants, or severe organ problems are excluded. Participation involves regular blood tests every 1–3 months to monitor whether the leukemia remains under control, with the original dose restarted if the disease comes back. This summary was prepared using AI to help patients understand the study in plain language.

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

DRUGTKI

halve dose of 2G-TKI for 12 months and then withdrawal for 12 months


Locations(2)

NanfangH

Guangzhou, Guangdong, China

NanfangH

Guangzhou, Guangdong, China

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NCT05341050