Chronic Myeloid LeukemiaENACTNCT00905593
Nilotinib in Adult Patients With Imatinib-resistant or Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
A study testing Nilotinib in people with Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 2 sites in Mexico.
Trial summary
Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on [CAMN107A2109] excluding discontinued patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Nilotinib
- How many people
- Not given
- Where
- 2 sitesMexico
- Study dates
- Sep 2008to Apr 2011
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Having participated in Novartis study CAMN107A2109, and
- Written signed and dated informed consent prior to any study procedures being performed.
Who cannot join
- Impaired cardiac function,
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions,
- Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval,
- patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days,
- Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR
- Patients unwilling or unable to comply with the protocol.
- Other protocol -defined inclusion/exclusion criteria may apply
Trial locations and contacts
2 sites in 1 country.
Mexico2 sites
Novartis Investigative Site
Guadalajara, Jalisco
Novartis Investigative Site
Mexico City
About this study
Official title: An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on [CAMN107A2109] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Nilotinib
- Keywords
- chronic myeloid leukemia,, blast crisis,, accelerated phase,, nilotinib,, imatinib,, resistant,, intolerant,, chronic phase
- 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2009 (estimated)
- Study startSep 2008
- Primary completionApr 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid 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)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00905593
- Sponsor's protocol ID
- CAMN107AMX01
- Acronym
- ENACT
- Status last verified
- Jul 2012
- First submitted
- 18 May 2009
- Last updated
- 18 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study Providing Continuation of Nilotinib in Adult Patients With Imatinib-(Glivec®/Gleevec®) - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
- ClinicalTrials.gov ID
- NCT00905593
- Acronym / sponsor ID
- ENACT / CAMN107AMX01
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- chronic myeloid leukemia,, blast crisis,, accelerated phase,, nilotinib,, imatinib,, resistant,, intolerant,, chronic phase
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Apr 2011 (estimated)
- First posted
- 20 May 2009 (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.
Multi-center, open-label, non-randomized trial to evaluate long-term safety and efficacy of nilotinib. Approximately 20 patients will be enrolled in this trial at 3 centers in Mexico, which means all ongoing patients participating on [CAMN107A2109] excluding discontinued patients. During this study, patients will receive nilotinib orally, at a dose of 400 mg b.i.d. Patients will normally receive nilotinib on an outpatient basis. This trial will have a maximum of 24 months of follow-up time.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Having participated in Novartis study CAMN107A2109, and
- Written signed and dated informed consent prior to any study procedures being performed.
Key exclusion criteria (7 listed)
- Impaired cardiac function,
- Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon) up to the day before study drug administration; Other concurrent severe and/or uncontrolled medical conditions,
- Patients who are currently receiving treatment with any of the medications that have the potential to prolong the QT interval,
- patients who have undergone a major surgery and have not recovered from side effects of such therapy within 15 days,
- Patients who are pregnant or breast feeding or adults of reproductive potential not employing an effective method of birth control, OR
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 18 Jul 2012.
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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
2 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 Myeloid Leukemia, run by Novartis Pharmaceuticals at 2 sites in Mexico.
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 2 inclusion and 7 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 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Mexico. 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 18 Jul 2012.