A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients

Chronic Myelogenous Leukemia Clinical Trial

Official title:

Multi-center, Single Stage Phase II Study to Evaluate the Efficacy and Safety of Flumatinib in Accelerated or Blastic Phase Chronic Myelogenous Leukemia Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02511340
• Other study ID #: HHGV678-204
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 26, 2015
• Last updated: July 29, 2015
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: July 2015
• Source: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Multi-center, single stage, phase II study to evaluate the efficacy and safety of Flumatinib in accelerated or blastic Phase chronic myelogenous leukemia patients.

Description:

Multi-center, single-arm, open-label,phase II study to investigate efficacy and safety of Flumatinib in Chinese patients with accelerated or blastic Phase chronic myelogenous leukemia. The starting daily oral dose of Flumatinib is 600mg，core test is six cycles (each cycle is 28 days), collecting the core test data for primary efficacy analysis. The longest treatment time is 12 cycles.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 167
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Male or female patients age 18-75 year-old;

• ECOG 0 - 2;

• Newly diagnosed or previously treated Ph+ CML patients in accelerated or blastic Phase;

• Adequate organ function;

• Written informed consent prior to any study procedures being performed.

Exclusion Criteria:

• Patients in Chronic and Blastic Phases;

• Previously treated with Flumatinib;

• Previously documented T315I mutations;

• Previous therapy within protocol defined timeframe, including:

• hydroxyurea within 24 hr,

• Imatinib or Nilotinib or Dasatinib within 28 days)

• Cardiac dysfunction ;

• History of congenital or acquired bleeding disorders unrelated to CML;

• Central nervous system leukemia;

• Previous malignancy except CML;

• Acute or chronic liver or severe kidney disease unrelated to CML;

• Pregnant, breastfeeding, child bearing potential but failed to take effective contraception.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blast Crisis
• Chronic Myelogenous Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Intervention

Drug:
• Flumatinib mesylate tablet 600 mg qd
Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients

Locations

Country	Name	City	State
China	Union Hospital Tongji Medical College Huazhong University of Science and technology	Wuhan	Hubei

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	Confirmed overall hematologic response(OHR)at 6 months		6 months	No