A Study of Nilotinib in Adult Patients With Imatinib Resistant or - Intolerant Chronic Myeloid Leukemia in Blast Crisis, Accelerated Phase or Chronic Phase
ENACT
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
1 other identifier
interventional
6
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 18, 2010
CompletedFirst Posted
Study publicly available on registry
May 20, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedFebruary 28, 2017
February 1, 2017
2.2 years
May 18, 2010
February 24, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maintain and monitor long-term hematological and cytogenetic responses previously obtained by patients participating in the CAMN107A2109 study.
between 6 and 12 months
Secondary Outcomes (3)
To evaluate the rate of any durable cytogenetic response and Complete cytogenetic response
24 months
To evaluate the rate of molecular response every 3 months, until 24th month of treatment or end of study
24 months
To follow loss of HR (after previous confirmed HR for AP and CHR for CP)
3, 6 and 12 months
Study Arms (1)
Nilotinib
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Pregnant women or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hospital San José, Bogotá, Colombia
Bogotá, Colombia
Banco Municipal de Sangre
Caracas, Venezuela
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticlas
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2010
First Posted
May 20, 2010
Study Start
January 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
February 28, 2017
Record last verified: 2017-02