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

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

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 Overview

• Status: Unknown
• Conditions: Chronic Myelogenous Leukemia
• Intervention / Treatment: Drug: Flumatinib mesylate tablet 600 mg qd

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 Type: Interventional
• Enrollment (Anticipated): 167
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Confirmed overall hematologic response（OHR）at 6 months	6 months

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Kaiyan Liu, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (ANTICIPATED): August 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: July 26, 2015
• First Submitted That Met QC Criteria: July 29, 2015
• First Posted (ESTIMATE): July 30, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): July 30, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; HH-GV-678
• Other Study ID Numbers: HHGV678-204