A Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) - Full Text View

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00471497

Purpose

In this study, the efficacy and safety of two nilotinib doses, 300 mg twice daily and 400 mg twice daily, will be compared with imatinib 400 mg once daily in newly diagnosed patients with Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

Condition	Intervention	Phase
Myelogenous Leukemia, Chronic	Drug: nilotinib Drug: imatinib	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Multi-center, Open-label, Randomized Study of Imatinib Versus Nilotinib in Adult Patients With Newly Diagnosed Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP)

Resource links provided by NLM:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome tetrasomy 18p

MedlinePlus related topics: Cancer Chronic Myeloid Leukemia Leukemia

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

To compare the rate of major molecular response (MMR)as measured by real-time quantitative polymerase chain reaction (RQ-PCR) at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the rate of durable MMR at 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
To compare the rate reduction in BCR-ABL transcript levels in nilotinib treatment arms with imatinib at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
To compare the rate of complete cytogenetic response (CCyR) in nilotinib treatment arms with imatinib at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment:	846
Study Start Date:	July 2007
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: nilotinib 300mg bid (investigating arm)	Drug: nilotinib
Experimental: Nilotinb 400 mg bid (investigating arm)	Drug: nilotinib
Experimental: imatinib 400mg QD (control arm)	Drug: imatinib

Eligibility

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

Criteria

Inclusion criteria:

Chronic myelogenous leukemia in chronic phase patients within the first 6 months of diagnosis.
Diagnosis of chronic myelogenous leukemia in chronic phase with confirmation of Philadelphia chromosome

Exclusion criteria:

Treatment with a tyrosine kinase inhibitor prior to study entry is not allowed except for no more than 2 weeks in duration of imatinib
Any medical treatment for CML prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide
Uncontrolled or significant cardiovascular disease.
Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471497

Show 63 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers. This link exits the ClinicalTrials.gov site

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kantarjian HM, Hochhaus A, Saglio G, De Souza C, Flinn IW, Stenke L, Goh YT, Rosti G, Nakamae H, Gallagher NJ, Hoenekopp A, Blakesley RE, Larson RA, Hughes TP. Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. Lancet Oncol. 2011 Sep;12(9):841-51. Epub 2011 Aug 17.

Cortes JE, Hochhaus A, le Coutre PD, Rosti G, Pinilla-Ibarz J, Jabbour E, Gillis K, Woodman RC, Blakesley RE, Giles FJ, Kantarjian HM, Baccarani M. Minimal cross-intolerance with nilotinib in patients with chronic myeloid leukemia in chronic or accelerated phase who are intolerant to imatinib. Blood. 2011 May 26;117(21):5600-6. Epub 2011 Apr 5.

Saglio G, Kim DW, Issaragrisil S, le Coutre P, Etienne G, Lobo C, Pasquini R, Clark RE, Hochhaus A, Hughes TP, Gallagher N, Hoenekopp A, Dong M, Haque A, Larson RA, Kantarjian HM; ENESTnd Investigators. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010 Jun 17;362(24):2251-9. Epub 2010 Jun 5.

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00471497 History of Changes
Other Study ID Numbers:	CAMN107A2303, EUDRACT 2007-000208-34
Study First Received:	May 7, 2007
Last Updated:	May 27, 2010
Health Authority:	United States: Food and Drug Administration; Japan: Ministry of Health, Labor & Welfare; Europe: European Medicne Agency (EMEA)

Keywords provided by Novartis:

leukemia
bone marrow
leukemia symptoms
lukemia
cml
complete blood count
lymphocyte
blood cancer
leukocytes
chronic leukemia
bone marrow biopsy
leukemia research
leukemia cells

bone marrow disease
chronic myeloid leukemia
blood cancer symptoms
white blood cell diseases
chronic myelogenous leukemia
leukemia treatment
leukemia facts
leucemia
facts about leukemia
myelogenous leukemia
newly diagnosed CML
newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP)

Additional relevant MeSH terms:

Leukemia
Leukemia, Myeloid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Philadelphia Chromosome
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Translocation, Genetic

Chromosome Aberrations
Pathologic Processes
Disease Attributes
Imatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012