Chronic Myelogenous LeukemiaPhase 4NCT01368523
Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Previously Enrolled to CAMN107A2109 Trial
A Phase 4 study testing nilotinib in people with Chronic Myelogenous Leukemia, run by Novartis Pharmaceuticals at 3 sites in Poland.
Trial summary
The purpose of this study is to provide patients with imatinib resistant/intolerant chronic myeloid leukemia - in blast crisis, accelerated phase and chronic phase, who have been previously enrolled to CAMN107A2109 and benefit from the treatment, with access to nilotinib (AMN107) in Poland until such time as the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myelogenous Leukemia
- What is being tested?
- nilotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesPoland
- Study dates
- Dec 2008to Jan 2010
- 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 or - intolerant Philadelphia chromosome-positive CML in chronic phase, accelerated phase or in blast crisis patients previously enrolled to CAMN107A2109 trial in Poland and continuing the treatment with nilotinib at the time of enrollment for this trial.
- In the opinion of the investigators would benefit from the further treatment with nilotinib
- No evidence of extramedullary leukaemic involvement, with the exception of liver and spleen
- Males or females ≥18 years of age
- WHO Performance Status of ≤ 2
- QTc ≤ 450 msec on the average of three serial baseline ECG (using the QTcF formula).
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- Patients must have the following laboratory values:
- Potassium within normal limits or corrected to within normal limits with supplements prior to the first dose of study medication
- Total calcium (corrected for serum albumin) within normal limits or correctable with supplements
- Magnesium within normal limits or corrected to within normal limits with supplements prior to the first dose of study medication
- Phosphorus ≥ LLN or correctable with supplements
- ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumour
- Alkaline phosphatase ≤ 2.5 x ULN unless considered due to tumour
- Serum bilirubin ≤ 1.5 x ULN
- Serum creatinine ≤ 1.5 x ULN or 24-hour creatinine clearance ≥ 50 ml/min
- Serum amylase ≤ 1.5 x ULN and serum lipase ≤ 1.5 x ULN
- Written signed and dated informed consent prior to any study procedures being performed.
Who cannot join
- Known T315I mutations
- Impaired cardiac function including any one of the following:
- LVEF < 45% or below the institutional lower limit of the normal range (whichever is higher) as determined by echocardiogram
- Inability to determine the QT interval on ECG
- Complete left bundle branch block
- Use of a ventricular-paced pacemaker
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- 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 the average of three serial baseline ECG (using the QTcF formula). If QTcF > 450 msec and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.
- History of clinically documented myocardial infarction
- History of unstable angina (during the last 12 months)
- Other clinically significant heart disease (e.g. 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
- Previous radiotherapy to ≥ 25% of the bone marrow
- Major surgery within 4 weeks prior to Day 1 of study or who have not recovered from prior surgery
- History of non-compliance to medical regimens or inability to grant consent
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
- 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 or who are within 5 half-lives of the last dose of this medication prior to starting study drug.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
Novartis Investigative Site
Gdansk
Novartis Investigative Site
Poznan
Novartis Investigative Site
Warsaw
About this study
Official title: An Open-label, Multicenter Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Previously Enrolled to ENACT (CAMN107A2109) Trial
The purpose of this study is to provide patients with imatinib resistant/intolerant chronic myeloid leukemia - in blast crisis, accelerated phase and chronic phase, who have been previously enrolled to CAMN107A2109 and benefit from the treatment, with access to nilotinib (AMN107) in Poland until such time as the treatment with this drug is financed by the National Health Found in Poland (via 'therapeutic program') or for a period of 18 months, whichever comes first.
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- nilotinib
- Keywords
- Chronic Myelogenous Leukemia, chronic phase, accelerated phase, blastic phase, nilotinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nilotinibDrug
Also called AMN107
| Study group | Role | What they receive |
|---|---|---|
| nilotinib | Experimental | Not described Receives: Drug: nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
hematologic response
Measured: 18 months
Secondary outcomes (1)
cytogenetic response
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2011 (estimated)
- Study startDec 2008
- Primary completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01368523
- Sponsor's protocol ID
- CAMN107APL01
- Other IDs
- EUDRACT 2008-000755-10
- Status last verified
- Nov 2016
- First submitted
- 6 Jun 2011
- Last updated
- 16 Nov 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study of Oral AMN107 (Nilotinib) in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase Previously Enrolled to ENACT (CAMN107A2109) Trial
- ClinicalTrials.gov ID
- NCT01368523
- Acronym / sponsor ID
- CAMN107APL01
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- Chronic Myelogenous Leukemia, chronic phase, accelerated phase, blastic phase, nilotinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Jan 2010 (actual)
- First posted
- 8 Jun 2011 (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.
The purpose of this study is to provide patients with imatinib resistant/intolerant chronic myeloid leukemia - in blast crisis, accelerated phase and chronic phase, who have been previously enrolled to CAMN107A2109 and benefit from the treatment, with access to nilotinib (AMN107) in Poland until such time as the treatment with this drug is financed by the National Health Found in Poland (via 'therapeutic program') or for a period of 18 months, whichever comes first.
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: nilotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in chronic phase, accelerated phase or in blast crisis patients previously enrolled to CAMN107A2109 trial in Poland and continuing the treatment with nilotinib at the time of enrollment for this trial.
- In the opinion of the investigators would benefit from the further treatment with nilotinib
- No evidence of extramedullary leukaemic involvement, with the exception of liver and spleen
- Males or females ≥18 years of age
- WHO Performance Status of ≤ 2
Key exclusion criteria (22 listed)
- Known T315I mutations
- Impaired cardiac function including any one of the following:
- 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
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 |
|---|---|---|
| nilotinibAlso: AMN107 | Drug | nilotinib |
Primary outcome
hematologic response
Time frame: 18 months
1 secondary outcome
cytogenetic response
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nilotinib in people with Chronic Myelogenous Leukemia, run by Novartis Pharmaceuticals at 3 sites in Poland.
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 17 inclusion and 22 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 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. 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?
hematologic response (time frame: 18 months). 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 16 Nov 2016.