- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00786812
Study of Treatment With Nilotinib in Adult Patients With Imatinib - Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase (MACS0439)
February 21, 2017 updated by: Novartis Pharmaceuticals
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
Study Overview
Study Type
Interventional
Enrollment (Actual)
89
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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MG
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Belo Horizonte, MG, Brazil, 30130-100
- Novartis Investigative Site
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PR
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Curitiba, PR, Brazil, 80060-900
- Novartis Investigative Site
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RJ
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Rio de Janeiro, RJ, Brazil, 20230-130
- Novartis Investigative Site
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RS
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Porto Alegre, RS, Brazil, 90035-903
- Novartis Investigative Site
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SP
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Campinas, SP, Brazil, 13083-970
- Novartis Investigative Site
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Jaú, SP, Brazil, 17210-080
- Novartis Investigative Site
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Ribeirao Preto, SP, Brazil, 14048-900
- Novartis Investigative Site
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São Paulo, SP, Brazil, 05403-000
- Novartis Investigative Site
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São Paulo, SP, Brazil, 01401-901
- Novartis Investigative Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: CAMN107A2109 Extension Patients
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Other: AMN107 Naive
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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3 - 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
January 1, 2012
Study Completion (Actual)
January 1, 2012
Study Registration Dates
First Submitted
November 5, 2008
First Submitted That Met QC Criteria
November 5, 2008
First Posted (Estimate)
November 6, 2008
Study Record Updates
Last Update Posted (Actual)
February 23, 2017
Last Update Submitted That Met QC Criteria
February 21, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAMN107ABR03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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