Clinical trial NCT01254188: Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients
Official title: Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Myeloid Leukemia
Keywords: Chronic myeloid leukemia,
CML,
nilotinib,
myelogenous,
Philadelphia chromosome
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 421
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will further investigate the safety and efficacy of nilotinib in newly diagnosed chronic myeloid leukemia patients in the chronic phase


Eligibility criteria: Inclusion Criteria:

-Patients with chronic myeloid leukemia in the chronic phase diagnosed within 6 months of study entry

Exclusion Criteria:

* Treatment with tyrosine kinase inhibitor or other antileukemic agents or treatments (including HSCT) for longer than 2 weeks, with exception of hydroxyurea and/or anagrelide
* Uncontrolled congestive heart failure or hypertension
* Myocardial infarction or unstable angina pectoris within past 12 months
* Known T315I mutations
* QTcF \>450 msec
* Significant arrhythmias

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: The Percentage of Patients Achieving MMR by 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Time to Molecular Response at 24 Months
timeFrame: 24 months
measure: Duration of Major Molecular Response
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected
measure: Complete Cytogenetic Response
timeFrame: 6 months
measure: Percentage of Participants Estimated to Maintain Their First CCyR for 6, 12, 18, and 24 Months After the First CCyR Was Achieved as Determined by Kaplan Meier Estimatation.
timeFrame: 6,12,18 and 24 months
measure: Overall Survival
timeFrame: 3, 6, 9, 12, 15, 18, 21, 24 Months
measure: Kaplan-Meier Estimates of Progression-free Survival
timeFrame: 3,6,9,12,15,18,21,and 24 months
measure: Kaplan-Meier Estimates of Failure-free Survival
timeFrame: 3,6,9,12,15,18,21,and 24 months
Other outcomes:
Locations:
city: Alger
country: Algeria
facility: Novartis Investigative Site
state: Bouzareah
city: Oran
country: Algeria
facility: Novartis Investigative Site
city: Caba
country: Argentina
facility: Novartis Investigative Site
state: Buenos Aires
city: Paraná
country: Argentina
facility: Novartis Investigative Site
state: Entre Rios
city: Buenos Aires
country: Argentina
facility: Novartis Investigative Site
city: Canberra
country: Australia
facility: Novartis Investigative Site
state: Australian Capital Territory
city: Concord NSW
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Gosford
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Kingswood
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Kogarah
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Liverpool
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: St. Leonards
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Westmead
country: Australia
facility: Novartis Investigative Site
state: New South Wales
city: Douglas
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Woolloongabba
country: Australia
facility: Novartis Investigative Site
state: Queensland
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Bedford Park
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Hobart
country: Australia
facility: Novartis Investigative Site
state: Tasmania
city: Box Hill
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Clayton
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Fitzroy
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Wodonga
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Nedlands
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Perth
country: Australia
facility: Novartis Investigative Site
state: Western Australia
city: Salvador
country: Brazil
facility: Novartis Investigative Site
state: BA
city: Goiania
country: Brazil
facility: Novartis Investigative Site
state: GO
city: Curitiba
country: Brazil
facility: Novartis Investigative Site
state: PR
city: Porto Alegre
country: Brazil
facility: Novartis Investigative Site
state: RS
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Moncton
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: Saint John
country: Canada
facility: Novartis Investigative Site
state: New Brunswick
city: St. John's
country: Canada
facility: Novartis Investigative Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: Barrie
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Brampton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Hamilton
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Weston
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Windsor
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Québec
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Saskatoon
country: Canada
facility: Novartis Investigative Site
state: Saskatchewan
city: Alexandria
country: Egypt
facility: Novartis Investigative Site
city: Cairo
country: Egypt
facility: Novartis Investigative Site
city: Cairo
country: Egypt
facility: Novartis Investigative Site
city: Mansoura
country: Egypt
facility: Novartis Investigative Site
city: Tamil Nadu
country: India
facility: Novartis Investigative Site
state: Chennai
city: Pune
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Vellore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Jerusalem
country: Israel
facility: Novartis Investigative Site
city: Petach Tikva
country: Israel
facility: Novartis Investigative Site
city: Ramat Gan
country: Israel
facility: Novartis Investigative Site
city: Beirut
country: Lebanon
facility: Novartis Investigative Site
city: Saida
country: Lebanon
facility: Novartis Investigative Site
city: Pulau Pinang
country: Malaysia
facility: Novartis Investigative Site
city: Selangor
country: Malaysia
facility: Novartis Investigative Site
city: Hermosillo
country: Mexico
facility: Novartis Investigative Site
state: Sonora
city: San Luis Potosi
country: Mexico
facility: Novartis Investigative Site
city: Muscat
country: Oman
facility: Novartis Investigative Site
city: Arkhangelsk
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Perm
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Tumen
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Irkutsk
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Nizhnii Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov-on-Don
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov-on-Don
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Tula
country: Russian Federation
facility: Novartis Investigative Site
city: Dammam
country: Saudi Arabia
facility: Novartis Investigative Site
city: Jeddah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Jeddah
country: Saudi Arabia
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
city: Riyadh
country: Saudi Arabia
facility: Novartis Investigative Site
city: Soweto
country: South Africa
facility: Novartis Investigative Site
state: Gauteng
city: Bloemfontein
country: South Africa
facility: Novartis Investigative Site
city: Observatory
country: South Africa
facility: Novartis Investigative Site
city: Parktown
country: South Africa
facility: Novartis Investigative Site
city: Pretoria
country: South Africa
facility: Novartis Investigative Site
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan, ROC
city: Lin-Kou
country: Taiwan
facility: Novartis Investigative Site
city: Niaosong Township
country: Taiwan
facility: Novartis Investigative Site
city: Taichung
country: Taiwan
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Sousse
country: Tunisia
facility: Novartis Investigative Site
state: Tunisie
city: Tunis
country: Tunisia
facility: Novartis Investigative Site
city: Dubai
country: United Arab Emirates
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.