- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01126892
A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase (ENACT)
February 24, 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
A multicenter, open label study of Nilotinib in CML patients PH + with imatininb resistant in blast crisis, accelerated phase or chronic phase.
The main purpose is evaluate the safety and efficacy of Nilotinib.
Study Overview
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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:
Stratum 1:
- Currently participating in Novartis study CAMN107A2109
- Written signed and dated informed consent prior to any study procedures being performed
Stratum 2:
- Male or female
- > 18 years
- ECOG 0,1,2
- ASL/ALT <= 2.5 ULN or <= 5.0 ULN
- Alcaline Phosfatase <= 2.5 ULN
- Serum Bilirrubin <= 1.5 ULN
- Serum Creatinine <= 1.5 ULN or creatinine clearance >=50 ml/min / 24 hours
- Serum Lipase <= 1.5 ULN
Exclusion Criteria:
Stratum 1 and stratum 2:
- Reduction of the cardiac function
- Use of Coumadin
- Other severe medical concurrent conditions
- Treatment with medications that prolonged the QT interval.
- Mayor surgery 15 days before the inclusion in the protocol
- Pregnant women or lactation
Other protocol-defined inclusion/exclusion criteria may apply
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nilotinib
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study.
Time Frame: between 6 and 12 months
|
between 6 and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response
Time Frame: 24 months
|
24 months
|
To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study
Time Frame: 24 months
|
24 months
|
To follow loss of HR (after previous confirmed HR for AP and CHR for CP)
Time Frame: 3, 6 and 12 months
|
3, 6 and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Novartis Pharmaceuticlas, Novartis Pharmaceuticals
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
January 1, 2009
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
May 18, 2010
First Submitted That Met QC Criteria
May 18, 2010
First Posted (Estimate)
May 20, 2010
Study Record Updates
Last Update Posted (Actual)
February 28, 2017
Last Update Submitted That Met QC Criteria
February 24, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAMN107ACO01
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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