A Phase II Study of Flumatinib Versus Imatinib to Treat Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
Phase II Study of Flumatinib Versus Imatinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)
1 other identifier
interventional
150
1 country
5
Brief Summary
It is an open-label, randomized, multi-center study. The efficacy and safety of two flumatinib doses, 400 mg once daily and 600 mg once daily, will be compared with imatinib 400 mg once daily in newly diagnosed (within 6 months) patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2011
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 1, 2012
CompletedFirst Posted
Study publicly available on registry
January 4, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 10, 2013
April 1, 2013
10 months
January 1, 2012
April 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To compare the rate of MMR at 6 months
Obtain major molecular response (MMR) rate at 6 months in newly diagnosed Ph+ CML patients through comparison of the efficacy results of flumatinib with that of imtinib.
6 months
Secondary Outcomes (1)
To compare the rate of MMR at 12 months
12 months
Study Arms (3)
flumatinib 400mg qd
EXPERIMENTALflumatinib 600 mg qd
EXPERIMENTALimatinib
ACTIVE COMPARATORInterventions
Flumatinib was supplied as 100 and 200 mg film-coated tablets for oral administration. Storage condition: 25°C, light proof, sealed.
Imatinib was supplied as 100 mg film-coated tablets. Storage condition: 25°C (77°F). Protected from moisture.
Eligibility Criteria
You may qualify if:
- Male or female patients ≥ 18 years and ≤ 75 years of age.
- ECOG 0, 1, or 2.
- Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome.
- Chronic myelogenous leukemia in chronic phase patients within the first 6 months of diagnosis.
- Adequate end organ function as defined by:
- Total bilirubin \< 1.5 x ULN,
- SGOT and SGPT \< 2.5 x ULN,
- Creatinine \< 1.5 x ULN,
- Serum amylase and lipase ≤ 1.5 x ULN,
- Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.
- And patients must have the following laboratory values (≥ LLN (lower limit of normal) or corrected to within normal limits with supplements prior to the first dose of study medication.):
- Potassium ≥ LLN,
- Magnesium ≥ LLN,
- Phosphorus ≥ LLN,
- Total calcium (corrected for serum albumin) ≥ LLN.
- +1 more criteria
You may not qualify if:
- Previously documented T315I mutations.
- Any medical treatment for CML prior to study entry with the exception of hydroxyurea and/or anagrelide. Treatment with tyrosine kinase inhibitor(s) prior to study entry is not allowed.
- Treatment with other investigational agents (defined as not used in accordance with the approved indication ) within 4 weeks prior to randomization.
- Major surgery within 4 weeks prior to randomization or who have not recovered from prior surgery.
- Impaired cardiac function including any one of the following:
- History of unstable angina.
- History of clinically documented myocardial infarction (during the last 12 month).
- LVEF \< 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by locally read echocardiogram.
- Inability to determine the QT interval on ECG.
- Complete left bundle branch block.
- Use of a ventricular-paced pacemaker.
- Congenital long QT syndrome or a known family history of long QT syndrome.
- History of or presence of clinically significant ventricular, atrial tachyarrhythmias, or QTcF \> 450 msec for male or 470 msec for female.
- Patients with active, uncontrolled psychiatric disorders including: psychosis, major depression, and bipolar disorders.
- Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Union Hospital Tongji Medical College Huazhong University of Science and technology
Wuhan, Hubei, 430022, China
The First Rffiurted Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, 300020, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianxiang Wang, Dr.
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
- PRINCIPAL INVESTIGATOR
Fengkui Zhang, Dr.
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 1, 2012
First Posted
January 4, 2012
Study Start
August 1, 2011
Primary Completion
June 1, 2012
Study Completion
December 1, 2014
Last Updated
April 10, 2013
Record last verified: 2013-04