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.
1 other identifier
observational
260
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2022
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 9, 2022
CompletedFirst Posted
Study publicly available on registry
April 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2026
ExpectedApril 22, 2022
April 1, 2022
3.8 years
April 9, 2022
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
MMR(BCR/ABL IS<0.1%) on 24 months
Continue to treat patients at half-dose for 12 months, then stop for 12 months
24 months
Secondary Outcomes (1)
MRFS
24 months
Study Arms (1)
patients with Ph+ CML-CP
Interventions
Eligibility Criteria
patients who have been diagnosed with CML-CP and are older than 18 years
You may qualify if:
- Male or female over 18 years
- Patients diagnosed as Ph+ (or Ph- but PCR-positive for BCR-ABL) CML-CP
- Patients have received one of the second-generation TKIs (nilotinib, dasatinib) for at least 3 years
- Patients have maintained MMR (BCR/ABL IS\<0.1% or more) at least 2 years
- in the past 24 months, at least three times recent molecular reactions have confirmed MMR
- Patients have signed the informed consent
You may not qualify if:
- patients with the presence or history of T315I mutation
- patients with the presence of rare unquantifiable atypical transcripts
- Patients with comorbid cardiovascular disease or a history of severe cardiovascular disease
- patients have history of accelerated or blast phase, or suspected blast disease
- patients have received allogeneic hematopoietic stem cell transplantation
- patients have severe abnormal liver and kidney function (ALT \> upper limit of normal, AST \> 3 times normal upper line, glomerular filtration rate \< 50%)
- patients combined with other tumors or a history of other malignancies ECOG score\>3
- Two-line abnormality in the patient's blood routine examination
- women is pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- xunalead
Study Sites (2)
NanfangH
Guangzhou, Guangdong, 510515, China
NanfangH
Guangzhou, Guangdong, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate chief physician
Study Record Dates
First Submitted
April 9, 2022
First Posted
April 22, 2022
Study Start
April 1, 2022
Primary Completion
December 31, 2025
Study Completion (Estimated)
May 31, 2026
Last Updated
April 22, 2022
Record last verified: 2022-04