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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.

Tracking Information
First Submitted Date  ICMJE July 29, 2014
First Posted Date  ICMJE July 30, 2014
Last Update Posted Date February 27, 2018
Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)		 SIX-month major molecular response rate [ Time Frame: six months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)		 major molecular response rate [ Time Frame: 3 months, 9 months and 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Study of the Efficacy and the Safety of Flumatinib vs Imatinib as First Line Treatment in Patients With CML
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE CML, CML-CP,MMR,TKI
Intervention  ICMJE
  • Drug: Flumatinib 600mg qd
  • Drug: Imatinib 400mg qd
Study Arms  ICMJE
  • Experimental: Flumatinib mesylate tablets
    Flumatinib mesylate tablets 600mg qd for 12 months
    Intervention: Drug: Flumatinib 600mg qd
  • Active Comparator: Imatinib mesylate tablets
    Imatinib mesylate tablets 400mg qd for 12months
    Intervention: Drug: Imatinib 400mg qd
Publications * Zhang L, Meng L, Liu B, Zhang Y, Zhu H, Cui J, Sun A, Hu Y, Jin J, Jiang H, Zhang X, Li Y, Liu L, Zhang W, Liu X, Gu J, Qiao J, Ouyang G, Liu X, Luo J, Jiang M, Xie X, Li J, Zhao C, Zhang M, Yang T, Wang J. Flumatinib versus Imatinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia: A Phase III, Randomized, Open-label, Multi-center FESTnd Study. Clin Cancer Res. 2021 Jan 1;27(1):70-77. doi: 10.1158/1078-0432.CCR-20-1600. Epub 2020 Sep 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2018)		 400
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2014)		 480
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date June 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02204644
Other Study ID Numbers  ICMJE HS-10096-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jiangsu Hansoh Pharmaceutical Co., Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Jiangsu Hansoh Pharmaceutical Co., Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu Hansoh Pharmaceutical Co., Ltd.
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP