Leukemia, Chronic MyeloidPhase 4NCT02389920
Multicenter, PhaseⅣ, Open Label Trial of Nilotinib in Adult Patients Diagnosed Philadelphia Chromosome Positive(Ph+) Chronic Myeloid Leukemia in CP/AP Intolerant to Dasatinib
A Phase 4 study testing Nilotinib in people with Leukemia, Chronic Myeloid, run by Samsung Medical Center.
Trial summary
Describe the purpose of the study: This study aims to evaluate the improvement of Dasatinib-related adverse events and to evaluate the treatment effect and safety by measuring the genetic response of nilotinib with nilotinib 400mg BID for 12 months in Philadelphia chromosome-positive chronic myeloid leukemia patients… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Leukemia, Chronic Myeloid
- What is being tested?
- Nilotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Dec 2018
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 19 years old
- Performance status (ECOG) of 0, 1, or 2
- Chronic phase or accelerated phase chronic myeloid leukemia being treated for more than two weeks, switch to nilotinib.
- Appropriate target organ function defined as;
- Bilirubin < 1.5 X ULN- Liver function test, AST (SGOT) and ALT (SGPT) < 2.5 X ULN- Creatinine < 1.5 X ULN- Serum amylase and lipase ≤ 1.5 X ULN- Alkaline phosphatase ≤ 2.5 X ULN (only if not related to tumor)
- Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to the start of study drug administration.
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- Should have laboratory results as follows.
- Potassium ≥ LLN- Magnesium ≥ LLN- Phosphorus ≥ LLN
- Voluntary, signed and dated informed consent prior to any study procedures being performed
Who cannot join
- Subjects with the T315I mutation
- Mutation known to be associated with low sensitivity to nilotinib(e.g., Y253H, E255K, E255V, F359V),
- Cardiac function abnormalities as follows are found.
- FEVI < 45% or less than lower limit of normal of each center on ECG
- QT interval cannot be measured on ECG
- Complete right bundle branch block
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- Using a ventricular pacemaker
- Congenital long QT syndrome or family history of long QT syndrome
- Past or present clinically significant ventricular or atrial tachycardia
- Clinically significant bradycardia at rest (< 50 beats/min)
- Regardless of toxicity after Dasatinib intake, QTc > 480 msec (using the QTcF formula) at baseline ECG. If QTcF > 480 msec and electrolytes are not within the normal range, it is necessary to correct electrolytes and re-assess the patient's QTc. According to the result of QTc, the investigator makes a decision on the patient's enrollment.
- Myocardial infarction within 12 months prior to the start of the study
- Other clinically significant heart disease (e.g., unstable angina, congestive heart failure or uncontrolled hypertension)
- Cytopathologically confirmed central nervous system lumbar puncture (spinal tapping is not needed if it is not suspected of association with central nervous system)
- Severe or uncontrolled disease (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection)
- History of significant congenital or acquired, bleeding disorder unrelated to cancer
- 25% or more of bone marrow has been treated with prior radiotherapy
- Not recovered from prior surgery or having a major surgery within 4 weeks from Day -1 of the study
- Treated with other investigational product within 30 days
- History of noncompliance with medical treatment or unable to voluntarily provide the written signed and dated informed consent
- Other primary cancer which is currently clinically significant and requires active treatment
- Currently treated with a strong CYP3A4 inhibitor (e.g., erythromycin, ketoconazole, itraconazol, voriconazol, clarithromycin, telithromycin, ritonavir, mibefradil), and the treatment cannot be stopped or switched to other drug before the start of study drug administration (For a complete list, refer to this link: http://medicine.iupui.edu/flockhart/table.htm.)
- Gastrointestinal dysfunction or gastrointestinal disease that may significantly change the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, small bowel resection, or gastric bypass)
- History of acute pancreatitis within the past 1 year or history of chronic pancreatitis
- Acute or chronic uncontrolled liver, pancreas or severe renal disease unrelated to the disease
- Currently treated with a drug which may prolong QT interval, and the treatment cannot be stopped or switched to other drug before the start of study drug administration (For a complete list of products which prolong QT interval, refer to http://www.torsades.org/medical-pros/drug-lists/printable-drug-list.cfm)
- Pregnant women, breast-feeding women
About this study
Describe the purpose of the study: This study aims to evaluate the improvement of Dasatinib-related adverse events and to evaluate the treatment effect and safety by measuring the genetic response of nilotinib with nilotinib 400mg BID for 12 months in Philadelphia chromosome-positive chronic myeloid leukemia patients intolerant to Dasatinib.
- Conditions
- Leukemia, Chronic Myeloid
- Being tested
- Nilotinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NilotinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Nilotinib | Experimental | nilotinib 400mg BID for 12 months Receives: Drug: Nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of improvement of Dasatinib-related adverse events
Measured: at 3 months of nilotinib treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionFeb 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leukemia, Chronic MyeloidStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chul Won Jung, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389920
- Sponsor's protocol ID
- 2014-01-112
- Status last verified
- Mar 2015
- First submitted
- 11 Mar 2015
- Last updated
- 17 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, PhaseⅣ, Open Label Trial of Nilotinib in Adult Patients Diagnosed Philadelphia Chromosome Positive(Ph+) Chronic Myeloid Leukemia in CP/AP Intolerant to Dasatinib
- ClinicalTrials.gov ID
- NCT02389920
- Acronym / sponsor ID
- 2014-01-112
- Conditions
- Leukemia, Chronic Myeloid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 17 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Describe the purpose of the study: This study aims to evaluate the improvement of Dasatinib-related adverse events and to evaluate the treatment effect and safety by measuring the genetic response of nilotinib with nilotinib 400mg BID for 12 months in Philadelphia chromosome-positive chronic myeloid leukemia patients intolerant to Dasatinib.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nilotinib | Experimental | Drug: Nilotinibnilotinib 400mg BID for 12 months |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women ≥ 19 years old
- Performance status (ECOG) of 0, 1, or 2
- Chronic phase or accelerated phase chronic myeloid leukemia being treated for more than two weeks, switch to nilotinib.
- Appropriate target organ function defined as;
- Women of childbearing potential must have a negative pregnancy test (urine or serum) within 7 days prior to the start of study drug administration.
Key exclusion criteria (27 listed)
- Subjects with the T315I mutation
- Mutation known to be associated with low sensitivity to nilotinib(e.g., Y253H, E255K, E255V, F359V),
- Cardiac function abnormalities as follows are found.
- Cytopathologically confirmed central nervous system lumbar puncture (spinal tapping is not needed if it is not suspected of association with central nervous system)
- Severe or uncontrolled disease (e.g., uncontrolled diabetes mellitus, active or uncontrolled infection)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nilotinib | Drug | Nilotinib |
Primary outcome
The rate of improvement of Dasatinib-related adverse events
Time frame: at 3 months of nilotinib treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nilotinib in people with Leukemia, Chronic Myeloid, run by Samsung Medical Center.
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 9 inclusion and 27 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 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
The rate of improvement of Dasatinib-related adverse events (time frame: at 3 months of nilotinib treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2015; AzTrials last refreshed its copy on 8 Nov 2026.