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Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients (ENESTxtnd)

Primary Purpose

Chronic Myeloid Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nilotinib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia focused on measuring Chronic myeloid leukemia,, CML,, nilotinib,, myelogenous,, Philadelphia chromosome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigative Site
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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nilotinib

Arm Description

300 mg BID

Outcomes

Primary Outcome Measures

The Percentage of Patients Achieving MMR by 12 Months
MMR is defined as BCR-ABL ratio (%) on IS <= 0.1% (corresponds to >=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method

Secondary Outcome Measures

Time to Molecular Response at 24 Months
Estimated median time to first MMR by Kaplan-Meier method
Duration of Major Molecular Response
Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) - date of first MMR + 1) / 30.4375
Complete Cytogenetic Response
Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.
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.
* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics. Duration of first CCyR (months) = (date of CCyR loss or censoring - date of first CCyR +1) / 30.4375
Overall Survival
OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.
Kaplan-Meier Estimates of Progression-free Survival
PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.
Kaplan-Meier Estimates of Failure-free Survival
Time to event (months) = (date of event or censoring - date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.

Full Information

First Posted
December 2, 2010
Last Updated
February 3, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01254188
Brief Title
Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients
Acronym
ENESTxtnd
Official Title
Extending Molecular Responses With Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia (CML) Patients in Chronic Phase
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia
Keywords
Chronic myeloid leukemia,, CML,, nilotinib,, myelogenous,, Philadelphia chromosome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
421 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nilotinib
Arm Type
Experimental
Arm Description
300 mg BID
Intervention Type
Drug
Intervention Name(s)
Nilotinib
Other Intervention Name(s)
AMN107
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Percentage of Patients Achieving MMR by 12 Months
Description
MMR is defined as BCR-ABL ratio (%) on IS <= 0.1% (corresponds to >=3 log reduction of BCR-ABL transcripts from standardized baseline value). Clopper-Pearson method
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Time to Molecular Response at 24 Months
Description
Estimated median time to first MMR by Kaplan-Meier method
Time Frame
24 months
Title
Duration of Major Molecular Response
Description
Kaplan-Meier estimates of duration of first MMR among patients who achieved MMR (FAS) Duration of first MMR (months) = (Minimum date of (loss of first MMR , CML-related death, progression to AP/BC during study treatment, censoring) - date of first MMR + 1) / 30.4375
Time Frame
3, 6, 9, 12, 15, 18, 21, 24 Months after MMR was detected
Title
Complete Cytogenetic Response
Description
Complete cytogenetic response (CCyR) is defined as a value of 0% Ph+ metaphases in bone marrow.
Time Frame
6 months
Title
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.
Description
* CCyR = 0% Ph+ metaphases based on at least 20 metaphases from bone marrow cytogenetics. Duration of first CCyR (months) = (date of CCyR loss or censoring - date of first CCyR +1) / 30.4375
Time Frame
6,12,18 and 24 months
Title
Overall Survival
Description
OS was defined as the time between date of study entry and date of death due to any cause at any time during the study, including the follow-up period after discontinuation of treatment.
Time Frame
3, 6, 9, 12, 15, 18, 21, 24 Months
Title
Kaplan-Meier Estimates of Progression-free Survival
Description
PFS was defined as the time from the date of study entry to the date of event defined as the first documented disease progression to AP/BC or the date of death from any cause occurring on treatment.
Time Frame
3,6,9,12,15,18,21,and 24 months
Title
Kaplan-Meier Estimates of Failure-free Survival
Description
Time to event (months) = (date of event or censoring - date of study entry + 1) / 30.4375. Date of event is the earliest date of the following events during treatment : discontinuation of nilotinib for nilotinib-related adverse events, death due to any cause, progression to AP or BC, loss of PCyR, loss of CCyR, loss of CHR. Time is censored at the date of last assessment in the trial for patients without event.
Time Frame
3,6,9,12,15,18,21,and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Alger
State/Province
Bouzareah
ZIP/Postal Code
16000
Country
Algeria
Facility Name
Novartis Investigative Site
City
Oran
ZIP/Postal Code
31000
Country
Algeria
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1221ADC
Country
Argentina
Facility Name
Novartis Investigative Site
City
Paraná
State/Province
Entre Rios
ZIP/Postal Code
E3100BBJ
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1114AAN
Country
Argentina
Facility Name
Novartis Investigative Site
City
Canberra
State/Province
Australian Capital Territory
ZIP/Postal Code
2605
Country
Australia
Facility Name
Novartis Investigative Site
City
Concord NSW
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Novartis Investigative Site
City
Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Novartis Investigative Site
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Novartis Investigative Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Novartis Investigative Site
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Novartis Investigative Site
City
St. Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Novartis Investigative Site
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Novartis Investigative Site
City
Douglas
State/Province
Queensland
ZIP/Postal Code
4810
Country
Australia
Facility Name
Novartis Investigative Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
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Australia
Facility Name
Novartis Investigative Site
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Novartis Investigative Site
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Novartis Investigative Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
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Australia
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Novartis Investigative Site
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Facility Name
Novartis Investigative Site
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
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Australia
Facility Name
Novartis Investigative Site
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
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Australia
Facility Name
Novartis Investigative Site
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
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Australia
Facility Name
Novartis Investigative Site
City
Wodonga
State/Province
Victoria
ZIP/Postal Code
3690
Country
Australia
Facility Name
Novartis Investigative Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Novartis Investigative Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Novartis Investigative Site
City
Salvador
State/Province
BA
ZIP/Postal Code
41253-190
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Brazil
Facility Name
Novartis Investigative Site
City
Goiania
State/Province
GO
ZIP/Postal Code
74605-020
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Brazil
Facility Name
Novartis Investigative Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-091
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Brazil
Facility Name
Novartis Investigative Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
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Canada
Facility Name
Novartis Investigative Site
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Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
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Canada
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Novartis Investigative Site
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Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z1Y6
Country
Canada
Facility Name
Novartis Investigative Site
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 6Z8
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Canada
Facility Name
Novartis Investigative Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2L 4L2
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Canada
Facility Name
Novartis Investigative Site
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
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Canada
Facility Name
Novartis Investigative Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
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Canada
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Novartis Investigative Site
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 6M2
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Canada
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Novartis Investigative Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6R 3J7
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Canada
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Novartis Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
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Canada
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Novartis Investigative Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
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Canada
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Novartis Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
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Canada
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Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
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Canada
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Novartis Investigative Site
City
Weston
State/Province
Ontario
ZIP/Postal Code
M9N 1N8
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Canada
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Novartis Investigative Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 2X3
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Canada
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Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Novartis Investigative Site
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada
Facility Name
Novartis Investigative Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
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Canada
Facility Name
Novartis Investigative Site
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
Facility Name
Novartis Investigative Site
City
Cairo
ZIP/Postal Code
11566
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Egypt
Facility Name
Novartis Investigative Site
City
Cairo
Country
Egypt
Facility Name
Novartis Investigative Site
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
Facility Name
Novartis Investigative Site
City
Tamil Nadu
State/Province
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
Novartis Investigative Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
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India
Facility Name
Novartis Investigative Site
City
Vellore
State/Province
Tamil Nadu
ZIP/Postal Code
632004
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India
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
9112001
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Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novartis Investigative Site
City
Ramat Gan
ZIP/Postal Code
5266202
Country
Israel
Facility Name
Novartis Investigative Site
City
Beirut
ZIP/Postal Code
166830
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Lebanon
Facility Name
Novartis Investigative Site
City
Saida
ZIP/Postal Code
652
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Lebanon
Facility Name
Novartis Investigative Site
City
Pulau Pinang
ZIP/Postal Code
10990
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Malaysia
Facility Name
Novartis Investigative Site
City
Selangor
ZIP/Postal Code
68000
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Malaysia
Facility Name
Novartis Investigative Site
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Hermosillo
State/Province
Sonora
ZIP/Postal Code
83000
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Mexico
Facility Name
Novartis Investigative Site
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San Luis Potosi
ZIP/Postal Code
78416
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Mexico
Facility Name
Novartis Investigative Site
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Muscat
ZIP/Postal Code
123
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Oman
Facility Name
Novartis Investigative Site
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Arkhangelsk
State/Province
Russia
ZIP/Postal Code
163045
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Russian Federation
Facility Name
Novartis Investigative Site
City
Novosibirsk
State/Province
Russia
ZIP/Postal Code
630051
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Russian Federation
Facility Name
Novartis Investigative Site
City
Perm
State/Province
Russia
ZIP/Postal Code
614077
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ryazan
State/Province
Russia
ZIP/Postal Code
390039
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
State/Province
Russia
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Tumen
State/Province
Russia
ZIP/Postal Code
625023
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Ekaterinburg
ZIP/Postal Code
620137
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Irkutsk
ZIP/Postal Code
664079
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Nizhnii Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Rostov-on-Don
ZIP/Postal Code
344090
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
St-Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Dammam
ZIP/Postal Code
15215
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Jeddah
ZIP/Postal Code
21423
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Jeddah
ZIP/Postal Code
21499
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Riyadh
ZIP/Postal Code
11211
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia
Facility Name
Novartis Investigative Site
City
Soweto
State/Province
Gauteng
ZIP/Postal Code
2013
Country
South Africa
Facility Name
Novartis Investigative Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Novartis Investigative Site
City
Observatory
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Novartis Investigative Site
City
Parktown
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0002
Country
South Africa
Facility Name
Novartis Investigative Site
City
Taipei
State/Province
Taiwan, ROC
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Lin-Kou
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Niaosong Township
ZIP/Postal Code
83301
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Novartis Investigative Site
City
Muang
ZIP/Postal Code
40002
Country
Thailand
Facility Name
Novartis Investigative Site
City
Sousse
State/Province
Tunisie
ZIP/Postal Code
4000
Country
Tunisia
Facility Name
Novartis Investigative Site
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia
Facility Name
Novartis Investigative Site
City
Dubai
Country
United Arab Emirates

12. IPD Sharing Statement

Citations:
PubMed Identifier
28699641
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.
Results Reference
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Safety and Efficacy of Nilotinib in Newly Diagnosed Chronic Myeloid Leukemia Patients

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