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

CML, CML-CP,MMR,TKI Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204644
• Other study ID #: HS-10096-301
• Status: Completed
• Phase: Phase 3
• First received: July 29, 2014
• Last updated: February 24, 2018
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: July 2014
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• CML, CML-CP,MMR,TKI
• Leukemia, Myeloid, Chronic-Phase

Intervention

Drug:
• Flumatinib 600mg qd

• Imatinib 400mg qd

Locations

Country	Name	City	State
China	Hospital of Blood Diseases, Chinese Academy of Medical Sciences	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Hansoh Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIX-month major molecular response rate		six months
Secondary	major molecular response rate		3 months, 9 months and 12 months