AzTrials
AzTrials

CMLPhase 4NCT01206088

Tasigna in Glivec-resistant or Intolerant Patients in CML

A Phase 4 study testing nilotinib in people with CML and Nilotinib, run by Novartis Pharmaceuticals at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete cytogenetic response rate(CCyR) at 12 months after nilotinib administration. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
CML, Nilotinib, Imatinib Resistant
What is being tested?
nilotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteSouth Korea
Study dates
Feb 2009to Sep 2012
Phase
Phase 4
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Imatinib resistant chronic myelogenous leukemia in chronic phase with cytogenetic confirmation of Philadelphia chromosome.
  • Documented chronic phase CML as defined by:
  • < 15% blasts in peripheral blood and bone marrow
  • < 30% blasts plus promyelocytes in peripheral blood and bone marrow
  • < 20% basophils in the peripheral blood
  • ≥ 100 x 109/L (≥ 100,000 /mm3) platelets
Show all 19Show fewer
  • No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
  • the patients with no CHR(complete hematologic response) after 3 months treatment, no mimical cytogenetic response(Ph+<65%) after 6 months treatment, no major cytogenetic response(Ph+<35%) after 12 months treatment.
  • Or
  • Imatinib resistant Philadelphia positive CML-AC will be defined as at lease one following and no bast crisis before treatment.
  • <30% and ≥ 15% blasts in peripheral blood and bone marrow
  • ≥ 30% blasts plus promyelocytes in peripheral blood and bone marrow
  • ≥ 20% basophils in the peripheral blood
  • < 100 x 109/L (≥ 100,000 /mm3) platelets without related treatment
  • progression of CML-AP with Imatinib treatment, no hematologic response in bone marrow after at least 4 weeks treatment with imatinib. Progression from AP will be defined by increased numbers more than 50% of peripheral WBCs, blasts, basophils and platelets.
  • definition of Imatinib intolerance in CML-CP and AP
  • the patients who discontinued imatinib treatment with any dosage due to Grade 3 or 4 non-hematologic adverse event or Grade 4 hematologic adverse event sustained for more than 7 days even best complementary therapy.
  • WHO performance scale ≤ 2
  • provide signed informed consent form

Who cannot join

  • Cardiac dysfunction : LVEF <45% by echocardiography, using pacemaker,Congenital long QT syndrome or a known family history of long QT syndrome, History of or presence of clinically significant ventricular or atrial tachyarrhythmias, Clinically significant resting brachycardia (<50 beats per minute),QTc > 450 msec on baseline ECG (using the QTcF formula), Myocardial infarction within 12 months prior to starting study, Other clinically significant heart disease (e.g. unstable angina, congestive heart failure or uncontrolled hypertension).
  • Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
  • Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
  • History of significant congenital or acquired bleeding disorder unrelated to cancer.
  • Treatment with any CSGF within 1 week of Day 1 except Erythropoietin.
  • History of non-compliance to medical regimens or inability to grant consent.
Show all 16Show fewer
  • Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
  • Patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention
  • Patients actively receiving therapy with strong CYP3A4 inhibitors (e.g, erythromycin, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, ritonavir, mibefradil) and the treatment cannot be either discontinued or switched to a different medication prior to starting study drug. See link for complete list of these medications: http://medicine.iupui.edu/flockhart/table.htm.. Novartis must be contacted if a patient needs to be started on any of these drugs during study treatment.
  • 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 acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.
  • patients who diagnosed HIV infection.
  • patients who has hypersensitivity for nilotinib or its additives
  • Patients who are currently receiving treatment with 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 (Please see http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm for a comprehensive list of agents that prolong the QT interval)
  • Patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use contraceptive precautions throughout the trial
  • Patients with rare genetic disease such as galactose intolerance, moderate lactase deficiency or glucose-galactose absorption disorder

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • St. Mary hospital, Catholic medical center

    Seoul

Other trials in South Korea

About this study

Official title: A Phase IV Study for Nilotinib in Patients With Imatinib-resistant or Intolerant Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML) in Chronic or Accelerated Phase.

The purpose of this study is to evaluate efficacy and safety of nilotinib in patients with Imatinib resistant or intolerant CML-CP or AC. Efficacy evaluation will be made by Complete cytogenetic response rate(CCyR) at 12 months after nilotinib administration.

Being tested
nilotinib

What participants receive

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

  • nilotinibDrug

    administration of nilotinib as 2nd line

Study groups in NCT01206088
Study groupRoleWhat they receive
nilotinibExperimentalNot described
Receives: Drug: nilotinib

What is being measured

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

  1. Complete cytogenetic response (CCyR) rate

    Measured: at 12 months

Secondary outcomes (1)

  1. evaluation of safety by NCI-CTCAE version 3.0

    Measured: until 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 posted21 Sep 2010 (estimated)
  2. Study startFeb 2009
  3. Primary completionSep 2012
  4. Study completionSep 2012

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01206088
Sponsor's protocol ID
CAMN107AKR02
Status last verified
Feb 2017
First submitted
20 Sep 2010
Last updated
28 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing nilotinib in people with CML and Nilotinib, run by Novartis Pharmaceuticals at 1 site in South Korea.

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 19 inclusion and 16 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: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Complete cytogenetic response (CCyR) rate (time frame: at 12 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 NCT01206088.

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 28 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in