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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Treatments: HH-GV-678; Imatinib Mesylate

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