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

Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02204644
Collaborator
(none)
400
Enrollment
1
Location
2
Arms
42
Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Flumatinib 600mg qd
  • Drug: Imatinib 400mg qd
 Phase 3

Study Design

Study Type:
Interventional
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 :
Jun 1, 2014
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

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

Primary Outcome Measures

  1. SIX-month major molecular response rate [six months]

Secondary Outcome Measures

  1. major molecular response rate [3 months, 9 months and 12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of Blood Diseases, Chinese Academy of Medical Sciences Tianjin Tianjin China 300020

Sponsors and Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jiangsu Hansoh Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02204644
Other Study ID Numbers:
  • HS-10096-301
First Posted:
Jul 30, 2014
Last Update Posted:
Feb 27, 2018
Last Verified:
Jul 1, 2014
Additional relevant MeSH terms:
Imatinib Mesylate
HH-GV-678

Study Results

No Results Posted as of Feb 27, 2018