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

Primary Purpose

Chronic Myelogenous Leukemia

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Flumatinib mesylate tablet 600 mg qd
Sponsored by
Jiangsu Hansoh Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myelogenous Leukemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Union Hospital Tongji Medical College Huazhong University of Science and technology

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flumatinib mesylate tablet 600 mg qd

Arm Description

Flumatinib, 600mg, qd

Outcomes

Primary Outcome Measures

Confirmed overall hematologic response（OHR）at 6 months

Secondary Outcome Measures

Full Information

First Posted
July 26, 2015
Last Updated
July 29, 2015
Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02511340
Brief Title
A Phase II Study to Evaluate the Efficacy and the Safety of Flumatinib in CML-AP or CML-BP Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Hansoh Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myelogenous Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
167 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flumatinib mesylate tablet 600 mg qd
Arm Type
Experimental
Arm Description
Flumatinib, 600mg, qd
Intervention Type
Drug
Intervention Name(s)
Flumatinib mesylate tablet 600 mg qd
Intervention Description
Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients
Primary Outcome Measure Information:
Title
Confirmed overall hematologic response（OHR）at 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kaiyan Liu
Organizational Affiliation
Peking University People's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Union Hospital Tongji Medical College Huazhong University of Science and technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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