- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01503502
A Phase II Study of Flumatinib Versus Imatinib to Treat Philadelphia Chromosome Positive Chronic Myelogenous Leukemia
April 9, 2013 updated by: Jiangsu HengRui Medicine Co., Ltd.
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)
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
It is an open-label, randomized, multi-center study in comparison of Gleevec and flumatinib in newly diagnosed (within 6 months) CML patients who are Philadelphia chromosome-positive.
One hundred and fifty adult patients will be randomized in 1:1:1 ratio.
The planned doses are as follows: 400 mg QD (50 patients) of flumatinib, 600 mg QD (50 patients) of flumatinib, and 400 mg QD (50 patients) of imatinib.
Flumatinib will be dosed, based on the food effect results, in fasting condition.
Imatinib will be dosed with food per the package insert.
The study consists of 2 phases: 6 months of core phase and 6 months of extension phase.
Study Type
Interventional
Enrollment (Actual)
150
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing
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Beijing, Beijing, China, 100044
- Peking University People's Hospital
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Hubei
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Wuhan, Hubei, China, 430022
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Jiangsu
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Suzhou, Jiangsu, China, 215006
- The First Rffiurted Hospital of Soochow University
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Shanghai
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Shanghai, Shanghai, China, 200025
- Ruijin Hospital
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Tianjin
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Tianjin, Tianjin, China, 300020
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- Signed informed consent.
Exclusion Criteria:
- 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).
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass surgery).
- History of significant congenital or acquired bleeding disorder unrelated to cancer.
- History of chronic pancreatitis or history of acute pancreatitis within 1 year of study entry.
- Patients with another primary malignancy.
- Acute or chronic uncontrolled liver or severe renal disease considered unrelated to disease.
- Known to be allergic to the study drugs, including crude drug or adjuvant.
- Patients actively receiving therapy with strong CYP3A4 inhibitors, strong CYP3A4 inducers or any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug.
- Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test within 7 days prior to Day 1 of study and (d) female of childbearing potential unwilling to use contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: imatinib
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Imatinib was supplied as 100 mg film-coated tablets.
Storage condition: 25°C (77°F).
Protected from moisture.
Other Names:
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Experimental: flumatinib 400mg qd
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Flumatinib was supplied as 100 and 200 mg film-coated tablets for oral administration.
Storage condition: 25°C, light proof, sealed.
Other Names:
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Experimental: flumatinib 600 mg qd
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Flumatinib was supplied as 100 and 200 mg film-coated tablets for oral administration.
Storage condition: 25°C, light proof, sealed.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the rate of MMR at 6 months
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare the rate of MMR at 12 months
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
June 1, 2012
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
January 1, 2012
First Submitted That Met QC Criteria
January 1, 2012
First Posted (Estimate)
January 4, 2012
Study Record Updates
Last Update Posted (Estimate)
April 10, 2013
Last Update Submitted That Met QC Criteria
April 9, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Chromosome Aberrations
- Translocation, Genetic
- Leukemia
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Philadelphia Chromosome
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Imatinib Mesylate
- HH-GV-678
Other Study ID Numbers
- HHGV678-201
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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