Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome and /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT01061177

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 primary objective of the study is to determine how effective nilotinib is in reducing the disease burden i.e. the number of patients with undetectable disease at 18 months.

Condition	Intervention	Phase
Leukemia, Myeloid	Drug: Nilotinib	Phase III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
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:

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Rate of complete molecular response (CMR). [ Time Frame: after 18 months of study drug ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the rate of annual disease progression and annual events at 12 and 24 months of treatment. [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
To evaluate the rate of major molecular response (MMR) after 12 and 24 months of study treatment. [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
To evaluate the rate of complete cytogenetic response after 12 and 24 months of study drug [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
To evaluate the rate of CMR (Complete Molecular response) after 12 and 24 months of study drug. [ Time Frame: at 12 and 24 months ] [ Designated as safety issue: No ]
evaluate the annual rate of events in patients achieving a CMR at 12 months. [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	806
Study Start Date:	March 2010
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nilotinib: Experimental	Drug: Nilotinib

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 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

Contacts

Contact: Novartis Pharmaceuticals

+1 800-340-6843

Locations

Germany
Novartis investigative Site
Jena, Germany

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CAMN107EIC01
Study First Received:	February 1, 2010
Last Updated:	February 2, 2010
ClinicalTrials.gov Identifier:	NCT01061177 History of Changes
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 - French Health Products Safety Agency; 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:

Philadelphia Chromosome
Leukemia
Neoplasms
Pathologic Processes
Neoplasms by Histologic Type
Hematologic Diseases

Chromosome Aberrations
Myeloproliferative Disorders
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Bone Marrow Diseases
Translocation, Genetic

ClinicalTrials.gov processed this record on February 08, 2010