Chronic Myeloid Leukemia (CML) in Chronic Phase
Conditions
Interventions
trail group:Nilotinib
Sponsors
The first people's Hospital of Yunnan Province
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age: >=18 and <=75 years old. 2.Diagnosis: Chronic myeloid leukemia in chronic phase (CML-CP). 3.Genetic confirmation: Philadelphia chromosome-positive (Ph+) and/or BCR-ABL1 fusion gene-positive. 4.Performance status: ECOG score of 0-1. 5.Treatment agreement: Voluntarily agrees to receive domestic nilotinib (Youdanuo®) therapy. 6.Informed consent: Willing to participate and has signed the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity or contraindication: Known allergy or contraindication to the investigational drug. 2.Active infections: Including but not limited to HBV, HCV, HIV, or other uncontrolled systemic infections. 3.Pregnancy/lactation: Female patients who are pregnant, breastfeeding, or have a positive pregnancy test (urine/serum) at screening. 4.Investigator’s discretion: Patients deemed ineligible by the investigator due to clinical or compliance concerns.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Hematologic Response (CHR) Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Major Molecular Response (MMR) Rate; | — |
Countries
China
Contacts
Public ContactYan Wen
The first people's Hospital of Yunnan Province
Outcome results
None listed