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

Phase 3

Completed

• Conditions: CML, CML-CP,MMR,TKI
• Interventions: Drug: Imatinib 400mg qd; Drug: Flumatinib 600mg qd

• Registration Number: NCT02204644
• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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 available

Study Timeline

• Study Start: 2014-06
• Status Verified: 2014-07
• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-07-29
• Study First Posted: 2014-07-30
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Last Update Submitted: 2018-02-24
• Last Update Posted: 2018-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Imatinib mesylate tablets	Imatinib 400mg qd	Imatinib mesylate tablets 400mg qd for 12months
Flumatinib mesylate tablets	Flumatinib 600mg qd	Flumatinib mesylate tablets 600mg qd for 12 months

Primary Outcome Measures

Name	Time	Method
SIX-month major molecular response rate	six months

Secondary Outcome Measures

Name	Time	Method
major molecular response rate	3 months, 9 months and 12 months

Trial Locations

Locations (1)

Hospital of Blood Diseases, Chinese Academy of Medical Sciences; 🇨🇳 Tianjin, Tianjin, China