Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome and /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase (ENEST1st)
This study is currently recruiting participants.
Verified April 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01061177
First received: February 1, 2010
Last updated: April 24, 2012
Last verified: April 2012
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Purpose
This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia, Myeloid |
Drug: Nilotinib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase IIIb, Multicentre, Open-label Study of Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome and/or BCR-ABL Positive CML in Chronic Phase |
Resource links provided by NLM:
Genetics Home Reference related topics:
17q21.31 microdeletion syndrome
isodicentric chromosome 15 syndrome
tetrasomy 18p
Drug Information available for:
Nilotinib
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Rate of complete molecular response (CMR). Levels of BCR-ABL transcripts will be determined by RQ-PCR testing of peripheral blood and analysed at an appropriate national EUTOS reference laboratory. [ Time Frame: after 18 months of study drug ] [ Designated as safety issue: No ]CMR is defined as undetectable BCR-ABL transcripts by quantitative RT-PCR in a peripheral blood sample of at least 10 ml with a minimum sensitivity of 1:10,000.
Secondary Outcome Measures:
- Rate of early progression to accelerated phase and blast crisis in year 1 and 2 and the rate of events in patients achieving a CMR at 1 year [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
- The rate of MMR at, as well as by, 12 and 24 months; the rate of CCyR at, as well as by , 12 and 24 months; the rate of CHR at, as well as by, 12 and 24 months [ Time Frame: at as welll as by 12 and 24 months ] [ Designated as safety issue: No ]
- The rate of early events, event free survival, overall survival; and safety and tolerability of nilotinib [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
- Exploratory endpoints patterns [ Time Frame: at, as well as, by 3, 6, 9, 12, 15, 21, and 24 months ] [ Designated as safety issue: No ]Exploratory endpoints include the kinetics of MMR and the dynamics of molecular response and potential patterns
| Estimated Enrollment: | 806 |
| Study Start Date: | May 2010 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Nilotinib |
Drug: Nilotinib
Other Name: AMN107
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or female patients with diagnosis of CP-CML with cytogenetic confirmation of Philadelphia (Ph) chromosome
- Ph negative cases or patients with variant translocations who are BCR-ABL positive in multiplex PCR are also eligible
- WHO performance status 0-2
- Laboratory assessments within normal limits
- Written informed consent prior to any study procedures being performed
Exclusion Criteria:
- Known impaired cardiac function
- History of acute or chronic pancreatitis
- Impaired gastrointestinal function or disease that may alter the absorption of study drug
- Concomitant medications with potential QT prolongation, or known to interact with CYP450 isoenzymes (CYP3A4, CYP2C9, and CYP2C8)
- Patients who have undergone major surgery ≤ 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy
- Patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. Female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01061177
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Contacts
| Contact: Novartis Pharmaceuticals | +1 800-340-6843 |
Show 288 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01061177 History of Changes |
| Other Study ID Numbers: | CAMN107EIC01 |
| Study First Received: | February 1, 2010 |
| Last Updated: | April 24, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicinal Products and Health Products Bosnia: Federal Ministry of Health Bulgaria: Bulgarian Drug Agency Croatia: Ministry of Health and Social Care Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency Estonia: The State Agency of Medicine Finland: Finnish Medicines Agency France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Greece: National Organization of Medicines Italy: The Italian Medicines Agency Latvia: State Agency of Medicines Lithuania: State Medicine Control Agency - Ministry of Health Netherlands: Medicines Evaluation Board (MEB) Norway: Norwegian Medicines Agency Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Portugal: National Pharmacy and Medicines Institute Romania: National Medicines Agency Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control Slovenia: Agency for Medicinal Products - Ministry of Health Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Novartis:
|
Leukemia myeloid myelogenous chronic BCR-ABL positive Nilotinib |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome Neoplasms by Histologic Type Neoplasms |
Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Translocation, Genetic Chromosome Aberrations Pathologic Processes |
ClinicalTrials.gov processed this record on October 17, 2012
