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

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT02511340
• Collaborator: (none)
• Enrollment: 167
• Location: 1
• Arm: 1
• Duration (Months): 35
• Patients Per Site Per Month: 4.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myelogenous Leukemia	Drug: Flumatinib mesylate tablet 600 mg qd	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 167 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jan 1, 2013
• Anticipated Primary Completion Date: Aug 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flumatinib mesylate tablet 600 mg qd Flumatinib, 600mg, qd	Drug: Flumatinib mesylate tablet 600 mg qd; Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients

Outcome Measures

Primary Outcome Measures

1. Confirmed overall hematologic response（OHR）at 6 months [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Union Hospital Tongji Medical College Huazhong University of Science and technology	Wuhan	Hubei	China	430022

Sponsors and Collaborators

• Jiangsu Hansoh Pharmaceutical Co., Ltd.

Investigators

• Study Chair: Kaiyan Liu, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02511340
• Other Study ID Numbers: HHGV678-204
• First Posted: Jul 30, 2015
• Last Update Posted: Jul 30, 2015
• Last Verified: Jul 1, 2015

• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; HH-GV-678

Study Results

No Results Posted as of Jul 30, 2015