Chronic Myelogenous LeukemiaNCT00413270
Oral Nilotinib in Adults With Chronic Myeloid Leukemia (CML) in Blast Crisis Who Are Imatinib Resistant or Intolerant
A study testing nilotinib in people with Chronic Myelogenous Leukemia, run by Novartis Pharmaceuticals at 18 sites in Canada.
Trial summary
This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market. 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
- How many people
- Not given
- Where
- 18 sitesCanada
- Study dates
- Dec 2006to not given
- Phase
- Expanded access
- 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 blast crisis
- Imatinib resistant or intolerant Philadelphia chromosome positive CML in accelerated phase
- Imatinib resistant or intolerant Philadelphia chromosome positive CML in chronic phase
- CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib resistance or intolerance
- World Health Organization (WHO) performance status ≤ 2
Who cannot join
- Cytopathologically confirmed central nervous system (CNS) infiltration
- Impaired cardiac function
- Use of therapeutic coumarin derivatives
- Acute chronic liver or renal disease unrelated to tumor
- Other uncontrolled medical conditions
- Treatment with hematopoeitic colony stimulating factors
Show all 9Show fewer
- Treatment with medications that have potential to prolong the QT interval
- Another malignancy currently clinically significant or requires active intervention
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Canada18 sites
Novartis Investigative Site
Brampton, Ontario
Novartis Investigative Site
Burnaby, British Columbia
Novartis Investigative Site
Calgary, Alberta
Novartis Investigative Site
Edmonton, Alberta
Novartis Investigative Site
Halifax, Nova Scotia
Novartis Investigative Site
Hamilton, Ontario
Novartis Investigative Site
London, Ontario
Novartis Investigative Site
Moncton, New Brunswick
Novartis Investigative Site
Montreal, Quebec
Novartis Investigative Site
Oshawa, Ontario
Novartis Investigative Site
Ottawa, Ontario
Novartis Investigative Site
Québec, Quebec
Novartis Investigative Site
Saskatoon, Saskatchewan
Novartis Investigative Site
Sherbrooke, Quebec
Novartis Investigative Site
St. John's, Newfoundland and Labrador
Novartis Investigative Site
Toronto, Ontario, q
Novartis Investigative Site
Vancouver, British Columbia
Novartis Investigative Site
Windsor, Ontario
About this study
Official title: A Canadian Open-label, Multicenter, Expanded Access Study of Oral Nilotinib in Adult Patients With Imatinib-resistant or -Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase
This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.
- Conditions
- Chronic Myelogenous Leukemia
- Being tested
- nilotinib
- Keywords
- Imatinib resistant,, Imatinib intolerant,, CML- blast crisis,, CML- Accelerated phase,, CML- chronic phase,, nilotinib,, Chronic myelogenous leukemia,, blast crisis,, accelerated phase,, chronic phase
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Myeloid, Accelerated Phase, Leukemia, Myeloid, Chronic-Phase, Blast Crisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nilotinibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startDec 2006
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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413270
- Sponsor's protocol ID
- CAMN107ACA01
- Status last verified
- Jul 2011
- First submitted
- 18 Dec 2006
- Last updated
- 13 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Canadian Open-label, Multicenter, Expanded Access Study of Oral Nilotinib in Adult Patients With Imatinib-resistant or -Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase, or Chronic Phase
- ClinicalTrials.gov ID
- NCT00413270
- Acronym / sponsor ID
- CAMN107ACA01
- Conditions
- Chronic Myelogenous Leukemia
- Keywords
- Imatinib resistant,, Imatinib intolerant,, CML- blast crisis,, CML- Accelerated phase,, CML- chronic phase,, nilotinib,, Chronic myelogenous leukemia,, blast crisis,
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- First posted
- 19 Dec 2006 (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.
This study will evaluate the safety of nilotinib in adult patients with imatinib-resistant or -intolerant CML-blast crisis, CML-accelerated phase or CML-chronic phase when treated with nilotinib. Patients will be provided access to nilotinib until the drug is available on the market.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Imatinib resistant or intolerant Philadelphia chromosome positive CML in blast crisis
- Imatinib resistant or intolerant Philadelphia chromosome positive CML in accelerated phase
- Imatinib resistant or intolerant Philadelphia chromosome positive CML in chronic phase
- CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib resistance or intolerance
- World Health Organization (WHO) performance status ≤ 2
Key exclusion criteria (9 listed)
- Cytopathologically confirmed central nervous system (CNS) infiltration
- Impaired cardiac function
- Use of therapeutic coumarin derivatives
- Acute chronic liver or renal disease unrelated to tumor
- Other uncontrolled medical conditions
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 | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2011.
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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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nilotinib in people with Chronic Myelogenous Leukemia, run by Novartis Pharmaceuticals at 18 sites in Canada.
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 5 inclusion and 9 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 13 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Canada. 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.
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.
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 13 Jul 2011.