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The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02204644
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : February 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study Description
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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


Condition or disease Intervention/treatment Phase
CML, CML-CP,MMR,TKI Drug: Flumatinib 600mg qd Drug: Imatinib 400mg qd Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Multi-center, Open-label Phase III Study of the Efficacy and Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia.
Study Start Date : June 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Flumatinib mesylate tablets
Flumatinib mesylate tablets 600mg qd for 12 months
 Drug: Flumatinib 600mg qd
Active Comparator: Imatinib mesylate tablets
Imatinib mesylate tablets 400mg qd for 12months
 Drug: Imatinib 400mg qd


Outcome Measures
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Primary Outcome Measures :
  1. SIX-month major molecular response rate [ Time Frame: six months ]

Secondary Outcome Measures :
  1. major molecular response rate [ Time Frame: 3 months, 9 months and 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204644


Locations
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China, Tianjin
Hospital of Blood Diseases, Chinese Academy of Medical Sciences
Tianjin, Tianjin, China, 300020
Sponsors and Collaborators
Jiangsu Hansoh Pharmaceutical Co., Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT02204644    
Other Study ID Numbers: HS-10096-301
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: July 2014
Additional relevant MeSH terms:
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Imatinib Mesylate
Flumatinib
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents