Status:
COMPLETED
The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML
Lead Sponsor:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
Conditions:
CML, CML-CP,MMR,TKI
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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,Con...
Eligibility Criteria
Inclusion
- Men and women aged 18-75 year-old
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2
- Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph + CP-CML) within 6 months of diagnosis
- Adequate organ function
Exclusion
- received TKIs drug treatment before enrollment
- Central nervous system leukemia
- Previous anti-CML therapy over two weeks (hydroxyurea, except anagrelide) or surgery (including hematopoietic stem cell transplantation)
- Cardiac dysfunction
- Previous splenectomy
- History of congenital or acquired bleeding disorders unrelated to CML
- Previous malignancy except CML
- Acute or chronic liver or severe kidney disease unrelated to CML
- Pregnant, breastfeeding, child bearing potential but failed to take effective contraception
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT02204644
Start Date
June 1 2014
End Date
December 1 2017
Last Update
February 27 2018
Active Locations (1)
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1
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020