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

Hansoh Pharma

Status and phase: Completed; Phase 3

Conditions: CML, CML-CP,MMR,TKI

Treatments: Drug: Flumatinib 600mg qd; Drug: Imatinib 400mg qd

Study type: Interventional

Funder types: Industry

Identifiers

NCT02204644

HS-10096-301

Details and patient eligibility

About

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

Enrollment: 400 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Flumatinib mesylate tablets

Experimental group

Description:

Flumatinib mesylate tablets 600mg qd for 12 months

Treatment:

Drug: Flumatinib 600mg qd

Imatinib mesylate tablets

Active Comparator group

Description:

Imatinib mesylate tablets 400mg qd for 12months

Treatment:

Drug: Imatinib 400mg qd