Chronic Myeloid LeukemiaPhase 4MACS0439NCT00786812
Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
A Phase 4 study testing Nilotinib in people with Chronic Myeloid Leukemia, run by Novartis Pharmaceuticals at 9 sites in Brazil.
Trial summary
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the [CAMN107A2109] study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Myeloid Leukemia
- What is being tested?
- Nilotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 9 sitesBrazil
- Study dates
- Aug 2008to Jan 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
- patients currrently participating in Novartis study CAMN107A2109
- imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)
- males or females ≥18 years of age
- WHO Performance Status of ≤ 2
- patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor
Who cannot join
- Impaired cardiac function; use of therapeutic coumarin derivatives
- 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
- patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy
- ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Brazil9 sites
Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30130-100
Novartis Investigative Site
Campinas, São Paulo, 13083-970
Novartis Investigative Site
Curitiba, Paraná, 80060-900
Novartis Investigative Site
Jaú, São Paulo, 17210-080
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90035-903
Novartis Investigative Site
Ribeirão Preto, São Paulo, 14048-900
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 20230-130
Novartis Investigative Site
São Paulo, São Paulo, 01401-901
Novartis Investigative Site
São Paulo, São Paulo, 05403-000
About this study
Official title: An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the [CAMN107A2109] study
- Conditions
- Chronic Myeloid Leukemia
- Being tested
- Nilotinib
- Keywords
- Leukemia, adult chronic myeloid leukemia, imatinib, nilotinib
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia
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 |
|---|---|---|
| CAMN107A2109 Extension Patients | Other | Not described Receives: Drug: Nilotinib |
| AMN107 Naive | Other | Not described Receives: Drug: Nilotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months
Measured: 3 - 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionJan 2012
- Study completionJan 2012
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 89 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
- NCT00786812
- Sponsor's protocol ID
- CAMN107ABR03
- Acronym
- MACS0439
- Status last verified
- Feb 2017
- First submitted
- 5 Nov 2008
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
- ClinicalTrials.gov ID
- NCT00786812
- Acronym / sponsor ID
- MACS0439 / CAMN107ABR03
- Conditions
- Chronic Myeloid Leukemia
- Keywords
- Leukemia, adult chronic myeloid leukemia, imatinib, nilotinib
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 6 Nov 2008 (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.
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the [CAMN107A2109] study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAMN107A2109 Extension Patients | Other | Drug: Nilotinib |
| AMN107 Naive | Other | Drug: Nilotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients currrently participating in Novartis study CAMN107A2109
- imatinib - resistant or intolerant - Philadelphia chromosome-positive CML in chronic (CML-CP)accelerated phase (CML-AP) or in blast crisis (CML-BC)
- males or females ≥18 years of age
- WHO Performance Status of ≤ 2
- patients must have the following laboratory values: ALT and AST ≤ 2.5 x ULN or ≤ 5.0 x ULN if considered due to tumor
Key exclusion criteria (5 listed)
- Impaired cardiac function; use of therapeutic coumarin derivatives
- 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
- patients who have received chemotherapy ≤ 1 week or who are within 5 half-lives of their last dose of chemotherapy
- ,.patients who have received imatinib or dasatinib at least 3 days prior to beginning of study drug or who have not recovered from side effects of such therapy
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 | AMN107 Naive, CAMN107A2109 Extension Patients |
Primary outcome
Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months
Time frame: 3 - 24 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 23 Feb 2017.
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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
9 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 Myeloid Leukemia, run by Novartis Pharmaceuticals at 9 sites in Brazil.
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 5 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 23 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 9 sites in Brazil. 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?
Disease response (complete hematologic response, cytogenetic response) and progression at or until 24 months, depending of the case every 3 months (time frame: 3 - 24 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 23 Feb 2017.