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Multicenter clinical study of CCLG-CML2025 protocol for Tyrosine kinase inhibitor de-escalation/intermittence and cessation

Multicenter clinical study of CCLG-CML2025 protocol for Tyrosine kinase inhibitor de-escalation/intermittence and cessation

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101313
Enrollment
Unknown
Registered
2025-04-23
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Myeloid Leukemia

Interventions

TKI de-escalation/intermittence-cessation group (the strategy was chosen according to patients' and guardians' will):NA

Sponsors

Beijing Childrens Hospital,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Patients who are 18 years or younger, and have a diagnosis of CML chronic phase; 2. Patients who have been taking TKI for = 36 months and have not experienced treatment failure (according to the definitions in ELN recommendations); 3. Patients must have a history of stable molecular response, defined as MR4 for =24 months, as documented by =5 separate tests; 4. Patients and/or their guardian are willing to give their consent to participate to the study.

Exclusion criteria

Exclusion criteria: 1. A history of blast crisis or accelerated phase; 2. Previous tyrosine kinase inhibitor resistance; 3. Patient has received hematopoietic stem cell transplantation or immunotherapy (including interferon); 4. There are two or more significant abnormalities in the blood routine; 5. Another malignant disease; 6. Patients complicated with any other diseases or psychiatric disease that could affect their safety and compliance, informed consent, participation, follow-up or interpretation of results.

Design outcomes

Secondary

MeasureTime frame
Overall;The rate of re-establishing MMR in children or adolescents who lost MMR afte TKI de-escalation, intermittence or cessation;Progression-free survival;

Primary

MeasureTime frame
?Z of Body Mass Index;Major Molecular Response;?Z of weight;Treatment-free remission;?Z of height;

Countries

China

Contacts

Public ContactHuyong Zheng

Beijing Childrens Hospital,Capital Medical University

zhenghuyong@bch.com.cn+86 10 59617600

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026