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A Phase II Study of Flumatinib Versus Imatinib to Treat Philadelphia Chromosome Positive Chronic Myelogenous Leukemia | Clinical Trials | Clareo Health

UNKNOWNPHASE2

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)

NCT01503502•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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).

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female patients ≥ 18 years and ≤ 75 years of age.
•2. ECOG 0, 1, or 2.
•3. Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome.
•4. Chronic myelogenous leukemia in chronic phase patients within the first 6 months of diagnosis.
•5. Adequate end organ function as defined by:
•1. Total bilirubin \< 1.5 x ULN,
•2. SGOT and SGPT \< 2.5 x ULN,
•3. Creatinine \< 1.5 x ULN,
•4. Serum amylase and lipase ≤ 1.5 x ULN,
•5. Alkaline phosphatase ≤ 2.5 x ULN unless considered tumor related.
+6 more criteria

Exclusion Criteria

•1. Previously documented T315I mutations.
•2. 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.
•3. Treatment with other investigational agents (defined as not used in accordance with the approved indication ) within 4 weeks prior to randomization.
•4. Major surgery within 4 weeks prior to randomization or who have not recovered from prior surgery.
•5. Impaired cardiac function including any one of the following:
•1. History of unstable angina.
•2. History of clinically documented myocardial infarction (during the last 12 month).
•3. LVEF \< 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by locally read echocardiogram.
•4. Inability to determine the QT interval on ECG.
•5. Complete left bundle branch block.
+13 more criteria

Locations (5)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Union Hospital Tongji Medical College Huazhong University of Science and technology

Wuhan, Hubei, China

The First Rffiurted Hospital of Soochow University

Suzhou, Jiangsu, China

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

August 1, 2011

Primary Completion Date

June 1, 2012

Completion Date

December 1, 2014

Last Updated

April 10, 2013

Enrollment

150

ACTUAL participants

Conditions

Myelogenous Leukemia, Chronic

Interventions

flumatinib

DRUG

imatinib

DRUG

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

NCT00471497

Myelogenous Leukemia, Chronic

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COMPLETEDNA

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NCT00179764

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Phase II Study of Flumatinib Versus Imatinib to Treat Philadelphia Chromosome Positive Chronic Myelogenous Leukemia

Inclusion Criteria

Exclusion Criteria

A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Immunoablative Mini Transplant (Hematopoietic Peripheral Blood Stem Cell Transplant [HPBSC])

An Extension Study of RO5045337 in Participants Participating in Previous Roche-sponsored Cancer Studies