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A prospective, multicenter clinical study of Nilotinib in pediatric patients with chronic myeloid leukemia in chronic phase

A prospective, multicenter clinical study of Nilotinib in pediatric patients with chronic myeloid leukemia in chronic phase

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067576
Enrollment
Unknown
Registered
2023-01-12
Start date
2023-01-12
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

chronic myeloid leukemia

Interventions

treatment group:Nilotinib Capsules

Sponsors

The First Affiliated Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.2 years old < age <=18 years old; 2. BCR-ABL1 positive chronic myeloid leukemia in chronic phase (CML-CP) diagnosed according to WHO (2017) criteria; 3. No chemotherapy other than TKI and hydroxyurea was received within 1 month before enrollment, and the duration of TKI or hydroxyurea treatment was not more than 1 week.

Exclusion criteria

Exclusion criteria: A history of blast crisis or accelerated phase; The parents or children refused the treatment regimen

Design outcomes

Primary

MeasureTime frame
major molecular response (MMR) at 12 months;—

Secondary

MeasureTime frame
time to first MR4.5;PCyR at 3 months;CCyR at 6 months;CCyR at 6 months;—

Countries

China

Contacts

Public ContactXiaoli Zhang

The First Affiliated Hospital, Sun Yat-sen University

sealuda@sina.com13642638645

Outcome results

None listed

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