Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients
NCT ID: NCT01254188
Last Updated: 2016-03-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
421 participants
INTERVENTIONAL
2011-04-30
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nilotinib
300 mg BID
Nilotinib
This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.
Interventions
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Nilotinib
This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Uncontrolled congestive heart failure or hypertension
* Myocardial infarction or unstable angina pectoris within past 12 months
* Known T315I mutations
* QTcF \>450 msec
* Significant arrhythmias
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Algiers, Bouzareah, Algeria
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Oran, , Algeria
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Buenos Aires, Buenos Aires, Argentina
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Caba, Buenos Aires, Argentina
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Paraná, Entre Ríos Province, Argentina
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Canberra, Australian Capital Territory, Australia
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Concord NSW, New South Wales, Australia
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Gosford, New South Wales, Australia
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Kingswood, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Liverpool, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Westmead, New South Wales, Australia
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Douglas, Queensland, Australia
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Woolloongabba, Queensland, Australia
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Adelaide, South Australia, Australia
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Bedford Park, South Australia, Australia
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Hobart, Tasmania, Australia
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Box Hill, Victoria, Australia
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Clayton, Victoria, Australia
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Fitzroy, Victoria, Australia
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Heidelberg, Victoria, Australia
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Parkville, Victoria, Australia
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Wodonga, Victoria, Australia
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Nedlands, Western Australia, Australia
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Perth, Western Australia, Australia
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Salvador, Estado de Bahia, Brazil
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Moncton, New Brunswick, Canada
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Saint John, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Brampton, Ontario, Canada
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Hamilton, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Weston, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Cairo, Cairo Governorate, Egypt
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Al Mansurah, , Egypt
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Alexandria, , Egypt
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Cairo, , Egypt
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Tamil Nadu, Chennai, India
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Pune, Maharashtra, India
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Vellore, Tamil Nadu, India
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Jerusalem, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Beirut, , Lebanon
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Saida, , Lebanon
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Kuala Selangor, , Malaysia
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Pulau Pinang, , Malaysia
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San Luis Potosí City, San Luis Potosí, Mexico
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Hermosillo, Sonora, Mexico
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Muscat, , Oman
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Arkhangelsk, Russia, Russia
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Novosibirsk, Russia, Russia
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Perm, Russia, Russia
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Ryazan, Russia, Russia
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Saint Petersburg, Russia, Russia
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Tyumen, Russia, Russia
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Irkutsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Rostov-on-Don, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Tula, , Russia
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Yekaterinburg, , Russia
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Dammam, , Saudi Arabia
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Jeddah, , Saudi Arabia
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Jeddah, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Soweto, Gauteng, South Africa
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Bloemfontein, , South Africa
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Observatory, , South Africa
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Parktown, , South Africa
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Pretoria, , South Africa
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Niaosong Township, Taiwan, Taiwan
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Taichung, Taiwan, Taiwan
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Taipei, Taiwan, ROC, Taiwan
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Linkou District, , Taiwan
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Chiang Mai, , Thailand
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Muang, , Thailand
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Sousse, Tunisie, Tunisia
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Tunis, , Tunisia
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Dubai, , United Arab Emirates
Countries
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References
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Hughes TP, Munhoz E, Aurelio Salvino M, Ong TC, Elhaddad A, Shortt J, Quach H, Pavlovsky C, Louw VJ, Shih LY, Turkina AG, Meillon L, Jin Y, Acharya S, Dalal D, Lipton JH. Nilotinib dose-optimization in newly diagnosed chronic myeloid leukaemia in chronic phase: final results from ENESTxtnd. Br J Haematol. 2017 Oct;179(2):219-228. doi: 10.1111/bjh.14829. Epub 2017 Jul 12.
Other Identifiers
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CAMN107E2401
Identifier Type: -
Identifier Source: org_study_id
NCT01580059
Identifier Type: -
Identifier Source: nct_alias
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