CML, CML-CP,MMR,TKI
Conditions
Brief summary
A study to observe the efficacy and the safety of Flumatinib vs Imatinib as first line treatment in patients with newly diagnosed chronic phase chronic myelogenous leukemia. Randomized,Open Label,Control
Interventions
DRUGFlumatinib 600mg qd
DRUGImatinib 400mg qd
Sponsors
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women aged 18-75 year-old 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 3. Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph + CP-CML) within 6 months of diagnosis 4. Adequate organ function
Exclusion criteria
1. received TKIs drug treatment before enrollment 2. Central nervous system leukemia 3. Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation) 4. Cardiac dysfunction 5. Previous splenectomy 6. History of congenital or acquired bleeding disorders unrelated to CML 7. Previous malignancy except CML 8. Acute or chronic liver or severe kidney disease unrelated to CML 9. Pregnant, breastfeeding, child bearing potential but failed to take effective contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SIX-month major molecular response rate | six months |
Secondary
| Measure | Time frame |
|---|---|
| major molecular response rate | 3 months, 9 months and 12 months |
Countries
China
Outcome results
None listed