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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)

Phase 2
18 Years
75 Years
Open (Enrolling)
Myelogenous Leukemia, Chronic

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Trial Information

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 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

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

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.

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.):

1. Potassium ≥ LLN,

2. Magnesium ≥ LLN,

3. Phosphorus ≥ LLN,

4. Total calcium (corrected for serum albumin) ≥ LLN.

6. Signed informed consent.

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

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.

6. Use of a ventricular-paced pacemaker.

7. Congenital long QT syndrome or a known family history of long QT syndrome.

8. History of or presence of clinically significant ventricular, atrial
tachyarrhythmias, or QTcF > 450 msec for male or 470 msec for female.

6. Patients with active, uncontrolled psychiatric disorders including: psychosis, major
depression, and bipolar disorders.

7. Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or
uncontrolled infection).

8. 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

9. History of significant congenital or acquired bleeding disorder unrelated to cancer.

10. History of chronic pancreatitis or history of acute pancreatitis within 1 year of
study entry.

11. Patients with another primary malignancy.

12. Acute or chronic uncontrolled liver or severe renal disease considered unrelated to

13. Known to be allergic to the study drugs, including crude drug or adjuvant.

14. 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.

15. 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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare the rate of MMR at 6 months

Outcome Description:

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.

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Jianxiang Wang, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


China: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

December 2014

Related Keywords:

  • Myelogenous Leukemia, Chronic
  • Myelogenous Leukemia
  • chronce
  • Philadelphia Chromosome Positive
  • Flumatinib
  • Leukemia
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Philadelphia Chromosome
  • Chronic Disease