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Myelogenous Leukemia, ChronicPhase 2NCT01503502

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

A Phase 2 study testing flumatinib and imatinib in people with Myelogenous Leukemia, Chronic, run by Jiangsu HengRui Medicine Co., Ltd. at 5 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Myelogenous Leukemia, Chronic
What is being tested?
flumatinib and imatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
5 sitesChina
Study dates
Aug 2011to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,
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  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

  • The First Rffiurted Hospital of Soochow University

    Suzhou, Jiangsu, 215006

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

    Tianjin, Tianjin Municipality, 300020

  • Union Hospital Tongji Medical College Huazhong University of Science and technology

    Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: 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).

Read the 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.

Being tested
flumatinib, imatinib
Keywords
Myelogenous Leukemia, chronce, Philadelphia Chromosome Positive, Flumatinib
Medical subject headings
Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • flumatinibDrug

    Also called HHGV678

    Flumatinib was supplied as 100 and 200 mg film-coated tablets for oral administration. Storage condition: 25°C, light proof, sealed.

  • imatinibDrug

    Also called Gleevec

    Imatinib was supplied as 100 mg film-coated tablets. Storage condition: 25°C (77°F). Protected from moisture.

Study groups in NCT01503502
Study groupRoleWhat they receive
flumatinib 400mg qdExperimentalNot described
Receives: Drug: flumatinib
flumatinib 600 mg qdExperimentalNot described
Receives: Drug: flumatinib
imatinibActive comparatorNot described
Receives: Drug: imatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Secondary outcomes (1)

  1. To compare the rate of MMR at 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionJun 2012
  4. Study completionDec 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01503502
Sponsor's protocol ID
HHGV678-201
Status last verified
Apr 2013
First submitted
1 Jan 2012
Last updated
10 Apr 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing flumatinib and imatinib in people with Myelogenous Leukemia, Chronic, run by Jiangsu HengRui Medicine Co., Ltd. at 5 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare the rate of MMR at 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01503502.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2013.

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