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Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase ('MACS1252)

Primary Purpose

CML in Chronic Phase

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Nilotinib

About this trial

This is an interventional treatment trial for CML in Chronic Phase focused on measuring Leukemia, myeloid, myelogenous, chronic BCR-ABL positive, Nilotinib, Philadelphia chromosome, CML in chronic phase

Eligibility Criteria

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

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 in multiplex PCR 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nilotinib

Arm Description

This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.

Outcomes

Primary Outcome Measures

Percentage of Participants With Molecular Response (MR4^0) at 18 Months

Secondary Outcome Measures

Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) at 12 and 24 Months

The following events were considered disease progression to AP/BC: Death due to disease under study; AP, as defined by any of the following: ≥ 15% blasts in the peripheral blood or bone marrow, but < 30% blasts in both the peripheral blood and bone marrow, ≥ 30% blasts plus promyelocytes in peripheral blood or bone marrow, ≥ 20% basophils in the peripheral blood, Thrombocytopenia (< 100 × 109/L) that was unrelated to therapy, Evidence of clonal evolution, as determined by medical review with consensus of the SSMC/DMC. BC was defined as: ≥ 30% blasts in peripheral blood or bone marrow, Appearance of extramedullary involvement other than hepatosplenomegaly proven by biopsy.

Rate of Event Free Survival at 12 and 24 Months

EFS was defined as the time from the date of Day 1 (first treatment) + 1 day to the first occurrence of any of the following: Loss of complete hematologic response (CHR), Loss of CCyR, Death from any cause, Progression to the AP or BC of CML, Not achieving CHR up to 3 months (ie, 91 + 15 days), Not achieving CCyR up to 18 months (ie, 548 + 15 days), whichever is earlier.

Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 24 Months

MMR was defined as BCR-ABL ratio (IS) ≤ 0.1% in a peripheral blood sample. BCR-ABL1 is an abnormal gene found in chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL). The chromosomal defect in the Philadelphia chromosome is a translocation, in which parts of two chromosomes, 9 and 22, swap places. The result is that a fusion gene is created by juxtapositioning the Abl1 gene on chromosome 9 to a part of the BCR ("breakpoint cluster region") gene on chromosome 22. Depending upon the breakpoints on the BCR gene, there are several forms of fusion proteins.

Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 12 and 24 Months

CCyR parameters were defined as 0% Philadelphia positive (Ph+) metaphases. Loss of CCyR was defined as a patient exceeding the CCyR criteria (ie, > 0% Ph+ metaphases) at a subsequent visit after the patient had achieved CCyR.

Percentage of Participants With Major Cytogenetic Response (MCyR) at, as Well as by, 12 and 24 Months

Major cytogenetic response (MCyR) parameters were defined as 0 to 35% Philadelphia positive (Ph+) metaphases.

Percentage of Participants Free From Progression to AP/BC With MR4^0 at 12 Months

Percentage of Participants With Event Free Survival in Participants Achieving MR4^0 at 12 Months

Percentage of Participants With Progression Free Survival (PFS) at 12 and 24 Months

PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.

Rate of Molecular Response (MR4^0) at, as Well as by, 12 and 24 Months

Rate of Molecular Response (MR4^5) at, as Well as by, 12 and 24 Months

MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).

Rate of Complete Hematologic Response (CHR) at, as Well as by, 12 and 24 Months

CHR was defined as all of the following present for ≥ 4 weeks in the peripheral blood: WBC count < 10 x 109/L, Platelet count < 450 x 109/L, No circulating peripheral blood blasts, promyelocytes, myelocytes, or metamyelocytes in the peripheral blood, The presence of < 5% basophils, No evidence of disease-related symptoms and extramedullary disease, including spleen and liver. Loss of CHR was defined as the appearance of any of the following after having achieved a CHR confirmed by a second determination ≥ 4 weeks later (unless associated with progression to AP/BC or death, which was considered to be a confirmed loss of CHR event on its own): WBC count that increased to > 20.0 x 109/L, Platelet count that increased to ≥ 600 x 109/L, Any palpable spleen, defined as size of spleen below costal margin > 5 cm, Appearance of > 5% myelocytes plus metamyelocytes, or any promyelocytes or blasts in the peripheral blood.

Percentage of Participants With Overall Survival at 12 and 24 Months

OS was defined as the time between the date of Day 1 (first treatment) and the date of death from any cause. Deaths which occurred after the 24-month time window and which were occasionally reported by some Investigators were excluded from the analysis. This is in agreement with the protocol stating that patients were to be followed for survival and progression to AP/BC up to 24 months after the participants treatment start.

Rate of Molecular Response (MR4^0) by 18 Months

MR4^0 was defined as either (i) detectable disease ≤ 0.01% BCR-ABL ratio (international scale (IS)) with mean ABL transcripts ≥ 10 000 or (ii) undetectable disease in complementary deoxyribonucleic acid (cDNA) with ≥ 10 000 ABL transcripts. BCR = Breakpoint Cluster Region gene/BCR gene product BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase

Rate of Molecular Response (MR4^5) by 18 Months

MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts). BCR = Breakpoint Cluster Region gene/BCR gene product BCR-ABL is fusion gene formed from the ABL gene from chromosome 9 fusing with the BCR gene on chromosome 22, the gene product is BCR-ABL tyrosine kinase

Percentage of Participants With Progression Free Survival in Participants Achieving MR4^0 at 12 Months

PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.

Full Information

NCT ID

NCT01061177

First Posted

February 1, 2010

Last Updated

January 4, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT01061177

Brief Title

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

Acronym

'MACS1252

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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 aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CML in Chronic Phase

Keywords

Leukemia, myeloid, myelogenous, chronic BCR-ABL positive, Nilotinib, Philadelphia chromosome, CML in chronic phase

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1090 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nilotinib

Arm Type

Experimental

Arm Description

This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.

Intervention Type

Drug

Intervention Name(s)

Nilotinib

Other Intervention Name(s)

AMN107

Intervention Description

Nilotinib was supplied by Novartis as 150 mg hard gelatin capsules in bottles. Nilotinib was dosed on a flat scale and not dosed by body weight. This form of supply was continued for all participants entered into the core study.

Primary Outcome Measure Information:

Title

Percentage of Participants With Molecular Response (MR4^0) at 18 Months

Description

Time Frame

at 18 months

Secondary Outcome Measure Information:

Title

Percentage of Participants Free From Progression to Accelerated Phase/Blast Crisis (AP/BC) at 12 and 24 Months

Description

Time Frame

at 12 and 24 months

Title

Rate of Event Free Survival at 12 and 24 Months

Description

Time Frame

at 12 and 24 months

Title

Percentage of Participants With Major Molecular Response (MMR) at, as Well as by, 12 and 24 Months

Description

Time Frame

12 months, 24 months

Title

Percentage of Participants With Complete Cytogenetic Response (CCyR) at, as Well as by, 12 and 24 Months

Description

Time Frame

12 and 24 months

Title

Percentage of Participants With Major Cytogenetic Response (MCyR) at, as Well as by, 12 and 24 Months

Description

Major cytogenetic response (MCyR) parameters were defined as 0 to 35% Philadelphia positive (Ph+) metaphases.

Time Frame

12 and 24 months

Title

Percentage of Participants Free From Progression to AP/BC With MR4^0 at 12 Months

Description

Time Frame

at 12 months

Title

Percentage of Participants With Event Free Survival in Participants Achieving MR4^0 at 12 Months

Description

Time Frame

at 12 months

Title

Percentage of Participants With Progression Free Survival (PFS) at 12 and 24 Months

Description

PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.

Time Frame

12 months, 24 months

Title

Rate of Molecular Response (MR4^0) at, as Well as by, 12 and 24 Months

Description

Time Frame

12 and 24 months

Title

Rate of Molecular Response (MR4^5) at, as Well as by, 12 and 24 Months

Description

MR4^5 was defined as either (i) detectable disease ≤ 0.0032% BCR-ABL ratio (IS) with mean ABL transcripts ≥ 32 000 or (ii) undetectable disease in cDNA with ≥ 32 000 ABL transcripts).

Time Frame

12 and 24 months

Title

Rate of Complete Hematologic Response (CHR) at, as Well as by, 12 and 24 Months

Description

Time Frame

12 months, 24 months

Title

Percentage of Participants With Overall Survival at 12 and 24 Months

Description

Time Frame

12 months, 24 months

Title

Rate of Molecular Response (MR4^0) by 18 Months

Description

Time Frame

by 18 months

Title

Rate of Molecular Response (MR4^5) by 18 Months

Description

Time Frame

by 18 months

Title

Percentage of Participants With Progression Free Survival in Participants Achieving MR4^0 at 12 Months

Description

PFS was defined by the study protocol as the time from the date of start of study drug to the date of earliest progression to AP/BC, or the date of death from any cause.

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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 in multiplex PCR 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

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

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Novartis Investigative Site

City

Innsbruck

ZIP/Postal Code

A-6020

Country

Austria

Facility Name

Novartis Investigative Site

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Novartis Investigative Site

City

Rankweil

ZIP/Postal Code

A-6830

Country

Austria

Facility Name

Novartis Investigative Site

City

Salzburg

ZIP/Postal Code

5020

Country

Austria

Facility Name

Novartis Investigative Site

City

Vienna

ZIP/Postal Code

A-1130

Country

Austria

Facility Name

Novartis Investigative Site

City

Wels

ZIP/Postal Code

A-4600

Country

Austria

Facility Name

Novartis Investigative Site

City

Wien

ZIP/Postal Code

A-1140

Country

Austria

Facility Name

Novartis Investigative Site

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussels

ZIP/Postal Code

BE-B-1200

Country

Belgium

Facility Name

Novartis Investigative Site

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Bruxelles

ZIP/Postal Code

1070

Country

Belgium

Facility Name

Novartis Investigative Site

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Novartis Investigative Site

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Hasselt

ZIP/Postal Code

3500

Country

Belgium

Facility Name

Novartis Investigative Site

City

Laeken

ZIP/Postal Code

1020

Country

Belgium

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Luxembourg

ZIP/Postal Code

1210

Country

Belgium

Facility Name

Novartis Investigative Site

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Verviers

ZIP/Postal Code

4800

Country

Belgium

Facility Name

Novartis Investigative Site

City

Yvoir

ZIP/Postal Code

5530

Country

Belgium

Facility Name

Novartis Investigative Site

City

Pleven

ZIP/Postal Code

5800

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Sofia

ZIP/Postal Code

1756

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Varna

ZIP/Postal Code

9000

Country

Bulgaria

Facility Name

Novartis Investigative Site

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Novartis Investigative Site

City

Olomouc

State/Province

CZE

ZIP/Postal Code

775 20

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Brno - Bohunice

ZIP/Postal Code

625 00

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Praha 2

ZIP/Postal Code

128 20

Country

Czech Republic

Facility Name

Novartis Investigative Site

City

Aarhus C

ZIP/Postal Code

DK-8000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Copenhagen

ZIP/Postal Code

DK-2100

Country

Denmark

Facility Name

Novartis Investigative Site

City

Odense C

ZIP/Postal Code

DK-5000

Country

Denmark

Facility Name

Novartis Investigative Site

City

Tartu

ZIP/Postal Code

51006

Country

Estonia

Facility Name

Novartis Investigative Site

City

HUS Helsinki

ZIP/Postal Code

FIN-00029

Country

Finland

Facility Name

Novartis Investigative Site

City

Oulu

ZIP/Postal Code

900114

Country

Finland

Facility Name

Novartis Investigative Site

City

Bayonne

State/Province

Bayonne cedex

ZIP/Postal Code

64109

Country

France

Facility Name

Novartis Investigative Site

City

Paris Cedex 10

State/Province

Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Novartis Investigative Site

City

Saint Denis

State/Province

FRANCE / La Reunion

ZIP/Postal Code

97405

Country

France

Facility Name

Novartis Investigative Site

City

Monte-Carlo

State/Province

Principauté de Monaco

ZIP/Postal Code

98012

Country

France

Facility Name

Novartis Investigative Site

City

Aix en Provence Cedex 1

ZIP/Postal Code

13616

Country

France

Facility Name

Novartis Investigative Site

City

Amiens cedex1

ZIP/Postal Code

80054

Country

France

Facility Name

Novartis Investigative Site

City

Angers Cedex 1

ZIP/Postal Code

49033

Country

France

Facility Name

Novartis Investigative Site

City

Argenteuil Cedex

ZIP/Postal Code

95107

Country

France

Facility Name

Novartis Investigative Site

City

Avignon cedex 9

ZIP/Postal Code

84902

Country

France

Facility Name

Novartis Investigative Site

City

Besancon cedex

ZIP/Postal Code

25030

Country

France

Facility Name

Novartis Investigative Site

City

Blois Cedex

ZIP/Postal Code

41016

Country

France

Facility Name

Novartis Investigative Site

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

Novartis Investigative Site

City

Brest

ZIP/Postal Code

29200

Country

France

Facility Name

Novartis Investigative Site

City

Caen

ZIP/Postal Code

14000

Country

France

Facility Name

Novartis Investigative Site

City

Chalon sur Saône

ZIP/Postal Code

71321

Country

France

Facility Name

Novartis Investigative Site

City

Chambéry cedex

ZIP/Postal Code

73011

Country

France

Facility Name

Novartis Investigative Site

City

Clermont-Ferrand cedex 1

ZIP/Postal Code

63003

Country

France

Facility Name

Novartis Investigative Site

City

Compiègne cedex

ZIP/Postal Code

60321

Country

France

Facility Name

Novartis Investigative Site

City

Corbeil Essonnes

ZIP/Postal Code

91100

Country

France

Facility Name

Novartis Investigative Site

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

Novartis Investigative Site

City

Dijon

ZIP/Postal Code

21034

Country

France

Facility Name

Novartis Investigative Site

City

Dunkerque

ZIP/Postal Code

59240

Country

France

Facility Name

Novartis Investigative Site

City

Grenoble

ZIP/Postal Code

38043

Country

France

Facility Name

Novartis Investigative Site

City

La Roche sur Yon cedex 9

ZIP/Postal Code

85925

Country

France

Facility Name

Novartis Investigative Site

City

Le Chesnay

ZIP/Postal Code

78157

Country

France

Facility Name

Novartis Investigative Site

City

Le Coudray

ZIP/Postal Code

28630

Country

France

Facility Name

Novartis Investigative Site

City

Le Mans Cedex 09

ZIP/Postal Code

72037

Country

France

Facility Name

Novartis Investigative Site

City

Lens Cedex

ZIP/Postal Code

62307

Country

France

Facility Name

Novartis Investigative Site

City

Lille cedex

ZIP/Postal Code

59020

Country

France

Facility Name

Novartis Investigative Site

City

Limoges cedex

ZIP/Postal Code

87042

Country

France

Facility Name

Novartis Investigative Site

City

Marseille cedex 20

ZIP/Postal Code

13915

Country

France

Facility Name

Novartis Investigative Site

City

Marseille

ZIP/Postal Code

13273

Country

France

Facility Name

Novartis Investigative Site

City

Metz Cedex 01

ZIP/Postal Code

57038

Country

France

Facility Name

Novartis Investigative Site

City

Montfermeil

ZIP/Postal Code

93370

Country

France

Facility Name

Novartis Investigative Site

City

Montpellier cedex 5

ZIP/Postal Code

34295

Country

France

Facility Name

Novartis Investigative Site

City

Mulhouse cedex

ZIP/Postal Code

68070

Country

France

Facility Name

Novartis Investigative Site

City

Mâcon Cedex

ZIP/Postal Code

71018

Country

France

Facility Name

Novartis Investigative Site

City

Nantes

ZIP/Postal Code

44035

Country

France

Facility Name

Novartis Investigative Site

City

Nice Cedex 2

ZIP/Postal Code

06189

Country

France

Facility Name

Novartis Investigative Site

City

Nimes

ZIP/Postal Code

32900

Country

France

Facility Name

Novartis Investigative Site

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Novartis Investigative Site

City

Pau

ZIP/Postal Code

64000

Country

France

Facility Name

Novartis Investigative Site

City

Perpignan

ZIP/Postal Code

66046

Country

France

Facility Name

Novartis Investigative Site

City

Pringy cedex

ZIP/Postal Code

74374

Country

France

Facility Name

Novartis Investigative Site

City

Reims

ZIP/Postal Code

51092

Country

France

Facility Name

Novartis Investigative Site

City

Rennes

ZIP/Postal Code

35019

Country

France

Facility Name

Novartis Investigative Site

City

Roubaix

ZIP/Postal Code

59100

Country

France

Facility Name

Novartis Investigative Site

City

Rouen Cedex 1

ZIP/Postal Code

76038

Country

France

Facility Name

Novartis Investigative Site

City

Saint Brieuc cedex 1

ZIP/Postal Code

22027

Country

France

Facility Name

Novartis Investigative Site

City

Saint Priest en Jarez Cedex

ZIP/Postal Code

42271

Country

France

Facility Name

Novartis Investigative Site

City

St Quentin Cedex

ZIP/Postal Code

02321

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg cedex

ZIP/Postal Code

67085

Country

France

Facility Name

Novartis Investigative Site

City

Strasbourg cedex

ZIP/Postal Code

67091

Country

France

Facility Name

Novartis Investigative Site

City

Toulouse Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Novartis Investigative Site

City

Tours Cedex 9

ZIP/Postal Code

37044

Country

France

Facility Name

Novartis Investigative Site

City

Troyes

ZIP/Postal Code

10003

Country

France

Facility Name

Novartis Investigative Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Aachen

ZIP/Postal Code

52074

Country

Germany

Facility Name

Novartis Investigative Site

City

Aschaffenburg

ZIP/Postal Code

63739

Country

Germany

Facility Name

Novartis Investigative Site

City

Augsburg

ZIP/Postal Code

86156

Country

Germany

Facility Name

Novartis Investigative Site

City

Bamberg

ZIP/Postal Code

96049

Country

Germany

Facility Name

Novartis Investigative Site

City

Bayreuth

ZIP/Postal Code

95445

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10707

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

10709

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

14195

Country

Germany

Facility Name

Novartis Investigative Site

City

Bielefeld

ZIP/Postal Code

33604

Country

Germany

Facility Name

Novartis Investigative Site

City

Bonn

ZIP/Postal Code

53105

Country

Germany

Facility Name

Novartis Investigative Site

City

Bottrop

ZIP/Postal Code

46236

Country

Germany

Facility Name

Novartis Investigative Site

City

Bremen

ZIP/Postal Code

28177

Country

Germany

Facility Name

Novartis Investigative Site

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Novartis Investigative Site

City

Duesseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Novartis Investigative Site

City

Duisburg

ZIP/Postal Code

47166

Country

Germany

Facility Name

Novartis Investigative Site

City

Eisenach

ZIP/Postal Code

99817

Country

Germany

Facility Name

Novartis Investigative Site

City

Eschweiler

ZIP/Postal Code

52249

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45136

Country

Germany

Facility Name

Novartis Investigative Site

City

Essen

ZIP/Postal Code

45147

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt, Oder

ZIP/Postal Code

15236

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

Novartis Investigative Site

City

Frankfurt

ZIP/Postal Code

60596

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Fulda

ZIP/Postal Code

36043

Country

Germany

Facility Name

Novartis Investigative Site

City

Giessen

ZIP/Postal Code

35392

Country

Germany

Facility Name

Novartis Investigative Site

City

Goslar

ZIP/Postal Code

38642

Country

Germany

Facility Name

Novartis Investigative Site

City

Greifswald

ZIP/Postal Code

17475

Country

Germany

Facility Name

Novartis Investigative Site

City

Hagen

ZIP/Postal Code

58097

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20246

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamm

ZIP/Postal Code

59063

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30170

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Herrsching

ZIP/Postal Code

82211

Country

Germany

Facility Name

Novartis Investigative Site

City

Hildesheim

ZIP/Postal Code

31134

Country

Germany

Facility Name

Novartis Investigative Site

City

Jena

ZIP/Postal Code

07740

Country

Germany

Facility Name

Novartis Investigative Site

City

Karlsruhe

ZIP/Postal Code

76133

Country

Germany

Facility Name

Novartis Investigative Site

City

Karlsruhe

ZIP/Postal Code

76135

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34119

Country

Germany

Facility Name

Novartis Investigative Site

City

Kassel

ZIP/Postal Code

34125

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24116

Country

Germany

Facility Name

Novartis Investigative Site

City

Koblenz

ZIP/Postal Code

56068

Country

Germany

Facility Name

Novartis Investigative Site

City

Landshut

ZIP/Postal Code

84028

Country

Germany

Facility Name

Novartis Investigative Site

City

Leipzig

ZIP/Postal Code

04103

Country

Germany

Facility Name

Novartis Investigative Site

City

Lemgo

ZIP/Postal Code

32657

Country

Germany

Facility Name

Novartis Investigative Site

City

Luebeck

ZIP/Postal Code

23563

Country

Germany

Facility Name

Novartis Investigative Site

City

Magdeburg

ZIP/Postal Code

39104

Country

Germany

Facility Name

Novartis Investigative Site

City

Mainz

ZIP/Postal Code

55131

Country

Germany

Facility Name

Novartis Investigative Site

City

Mannheim

ZIP/Postal Code

68169

Country

Germany

Facility Name

Novartis Investigative Site

City

Marburg

ZIP/Postal Code

35039

Country

Germany

Facility Name

Novartis Investigative Site

City

Moers

ZIP/Postal Code

47441

Country

Germany

Facility Name

Novartis Investigative Site

City

Muelheim

ZIP/Postal Code

45468

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

80335

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81241

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenchen

ZIP/Postal Code

81737

Country

Germany

Facility Name

Novartis Investigative Site

City

Muenster

ZIP/Postal Code

48149

Country

Germany

Facility Name

Novartis Investigative Site

City

Mutlangen

ZIP/Postal Code

73557

Country

Germany

Facility Name

Novartis Investigative Site

City

Mönchengladbach

ZIP/Postal Code

41063

Country

Germany

Facility Name

Novartis Investigative Site

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

Novartis Investigative Site

City

Neunkirchen

ZIP/Postal Code

66538

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

ZIP/Postal Code

90419

Country

Germany

Facility Name

Novartis Investigative Site

City

Nuernberg

ZIP/Postal Code

90449

Country

Germany

Facility Name

Novartis Investigative Site

City

Offenburg

ZIP/Postal Code

77652

Country

Germany

Facility Name

Novartis Investigative Site

City

Paderborn

ZIP/Postal Code

33102

Country

Germany

Facility Name

Novartis Investigative Site

City

Ravensburg

ZIP/Postal Code

88214

Country

Germany

Facility Name

Novartis Investigative Site

City

Rostock

ZIP/Postal Code

18057

Country

Germany

Facility Name

Novartis Investigative Site

City

Schorndorf

ZIP/Postal Code

73614

Country

Germany

Facility Name

Novartis Investigative Site

City

Schwäbisch-Hall

ZIP/Postal Code

74523

Country

Germany

Facility Name

Novartis Investigative Site

City

Sindelfingen

ZIP/Postal Code

71065

Country

Germany

Facility Name

Novartis Investigative Site

City

Stuttgart

ZIP/Postal Code

70376

Country

Germany

Facility Name

Novartis Investigative Site

City

Traunstein

ZIP/Postal Code

83278

Country

Germany

Facility Name

Novartis Investigative Site

City

Triberg

ZIP/Postal Code

78098

Country

Germany

Facility Name

Novartis Investigative Site

City

Ulm

ZIP/Postal Code

89081

Country

Germany

Facility Name

Novartis Investigative Site

City

Velbert

ZIP/Postal Code

42551

Country

Germany

Facility Name

Novartis Investigative Site

City

Viersen

ZIP/Postal Code

45468

Country

Germany

Facility Name

Novartis Investigative Site

City

Weilheim

ZIP/Postal Code

82362

Country

Germany

Facility Name

Novartis Investigative Site

City

Wendlingen

ZIP/Postal Code

73240

Country

Germany

Facility Name

Novartis Investigative Site

City

Wuerzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Novartis Investigative Site

City

Zella-Mehlis

ZIP/Postal Code

98544

Country

Germany

Facility Name

Novartis Investigative Site

City

Alexandroupolis

State/Province

Evros

ZIP/Postal Code

68100

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

State/Province

ZIP/Postal Code

115 27

Country

Greece

Facility Name

Novartis Investigative Site

City

Larissa

State/Province

ZIP/Postal Code

411 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Thessaloniki

State/Province

ZIP/Postal Code

546 42

Country

Greece

Facility Name

Novartis Investigative Site

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

Novartis Investigative Site

City

Heraklion Crete

ZIP/Postal Code

711 10

Country

Greece

Facility Name

Novartis Investigative Site

City

Patras

ZIP/Postal Code

265 00

Country

Greece

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Novartis Investigative Site

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Novartis Investigative Site

City

Kaposvar

ZIP/Postal Code

7400

Country

Hungary

Facility Name

Novartis Investigative Site

City

Pecs

ZIP/Postal Code

7624

Country

Hungary

Facility Name

Novartis Investigative Site

City

Szeged

ZIP/Postal Code

H-6725

Country

Hungary

Facility Name

Novartis Investigative Site

City

Ancona

State/Province

ZIP/Postal Code

60126

Country

Italy

Facility Name

Novartis Investigative Site

City

Avellino

State/Province

ZIP/Postal Code

83100

Country

Italy

Facility Name

Novartis Investigative Site

City

Bari

State/Province

ZIP/Postal Code

70124

Country

Italy

Facility Name

Novartis Investigative Site

City

Bologna

State/Province

ZIP/Postal Code

40138

Country

Italy

Facility Name

Novartis Investigative Site

City

Brindisi

State/Province

ZIP/Postal Code

72100

Country

Italy

Facility Name

Novartis Investigative Site

City

Brescia

State/Province

ZIP/Postal Code

25123

Country

Italy

Facility Name

Novartis Investigative Site

City

Cagliari

State/Province

ZIP/Postal Code

09121

Country

Italy

Facility Name

Novartis Investigative Site

City

Cagliari

State/Province

ZIP/Postal Code

09126

Country

Italy

Facility Name

Novartis Investigative Site

City

Cuneo

State/Province

ZIP/Postal Code

12100

Country

Italy

Facility Name

Novartis Investigative Site

City

Rossano

State/Province

ZIP/Postal Code

87067

Country

Italy

Facility Name

Novartis Investigative Site

City

Catanzaro

State/Province

ZIP/Postal Code

88100

Country

Italy

Facility Name

Novartis Investigative Site

City

Cona

State/Province

ZIP/Postal Code

44100

Country

Italy

Facility Name

Novartis Investigative Site

City

San Giovanni Rotondo

State/Province

ZIP/Postal Code

71013

Country

Italy

Facility Name

Novartis Investigative Site

City

Firenze

State/Province

ZIP/Postal Code

50134

Country

Italy

Facility Name

Novartis Investigative Site

City

Genova

State/Province

ZIP/Postal Code

16132

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

Lazio

ZIP/Postal Code

00168

Country

Italy

Facility Name

Novartis Investigative Site

City

Lecce

State/Province

ZIP/Postal Code

73100

Country

Italy

Facility Name

Novartis Investigative Site

City

Livorno

State/Province

ZIP/Postal Code

57124

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20122

Country

Italy

Facility Name

Novartis Investigative Site

City

Milano

State/Province

ZIP/Postal Code

20162

Country

Italy

Facility Name

Novartis Investigative Site

City

Modena

State/Province

ZIP/Postal Code

41100

Country

Italy

Facility Name

Novartis Investigative Site

City

Nuoro

State/Province

ZIP/Postal Code

08100

Country

Italy

Facility Name

Novartis Investigative Site

City

Palermo

State/Province

ZIP/Postal Code

90146

Country

Italy

Facility Name

Novartis Investigative Site

City

Padova

State/Province

ZIP/Postal Code

35128

Country

Italy

Facility Name

Novartis Investigative Site

City

Pescara

State/Province

ZIP/Postal Code

65124

Country

Italy

Facility Name

Novartis Investigative Site

City

Pisa

State/Province

ZIP/Postal Code

56126

Country

Italy

Facility Name

Novartis Investigative Site

City

Pesaro

State/Province

ZIP/Postal Code

61100

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Potenza

State/Province

ZIP/Postal Code

85100

Country

Italy

Facility Name

Novartis Investigative Site

City

Ravenna

State/Province

ZIP/Postal Code

48100

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Calabria

State/Province

ZIP/Postal Code

89124

Country

Italy

Facility Name

Novartis Investigative Site

City

Reggio Emilia

State/Province

ZIP/Postal Code

42123

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00144

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Nocera Inferiore

State/Province

ZIP/Postal Code

84014

Country

Italy

Facility Name

Novartis Investigative Site

City

Siena

State/Province

ZIP/Postal Code

53100

Country

Italy

Facility Name

Novartis Investigative Site

City

Sassari

State/Province

ZIP/Postal Code

07100

Country

Italy

Facility Name

Novartis Investigative Site

City

Taranto

State/Province

ZIP/Postal Code

74100

Country

Italy

Facility Name

Novartis Investigative Site

City

Orbassano

State/Province

ZIP/Postal Code

10043

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Terni

State/Province

ZIP/Postal Code

05100

Country

Italy

Facility Name

Novartis Investigative Site

City

Treviso

State/Province

ZIP/Postal Code

31100

Country

Italy

Facility Name

Novartis Investigative Site

City

Ronciglione

State/Province

ZIP/Postal Code

01100

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Novartis Investigative Site

City

Napoli

ZIP/Postal Code

80132

Country

Italy

Facility Name

Novartis Investigative Site

City

Novara

ZIP/Postal Code

28100

Country

Italy

Facility Name

Novartis Investigative Site

City

Perugia

ZIP/Postal Code

06129

Country

Italy

Facility Name

Novartis Investigative Site

City

Riga

State/Province

ZIP/Postal Code

1006

Country

Latvia

Facility Name

Novartis Investigative Site

City

Kaunas

ZIP/Postal Code

3007

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Klaipeda

ZIP/Postal Code

LT-92231

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Vilnius

ZIP/Postal Code

LT-08661

Country

Lithuania

Facility Name

Novartis Investigative Site

City

Amsterdam

ZIP/Postal Code

1081 HV

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Delft

ZIP/Postal Code

2625 AD

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Enschede

ZIP/Postal Code

7513 ER

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Nijmegen

ZIP/Postal Code

6525 GA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Rotterdam

ZIP/Postal Code

3075 EA

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Zwolle

ZIP/Postal Code

8025 AB

Country

Netherlands

Facility Name

Novartis Investigative Site

City

Bergen

ZIP/Postal Code

NO-5021

Country

Norway

Facility Name

Novartis Investigative Site

City

Oslo

ZIP/Postal Code

NO-0310

Country

Norway

Facility Name

Novartis Investigative Site

City

Stavanger

ZIP/Postal Code

4068

Country

Norway

Facility Name

Novartis Investigative Site

City

Tromsoe

ZIP/Postal Code

NO-9038

Country

Norway

Facility Name

Novartis Investigative Site

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

Facility Name

Novartis Investigative Site

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Novartis Investigative Site

City

Krakow

ZIP/Postal Code

30-510

Country

Poland

Facility Name

Novartis Investigative Site

City

Lublin

ZIP/Postal Code

20-081

Country

Poland

Facility Name

Novartis Investigative Site

City

Warsaw

ZIP/Postal Code

02-106

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

02-776

Country

Poland

Facility Name

Novartis Investigative Site

City

Wroclaw

ZIP/Postal Code

50-367

Country

Poland

Facility Name

Novartis Investigative Site

City

Lisboa

ZIP/Postal Code

1150-314

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200-072

Country

Portugal

Facility Name

Novartis Investigative Site

City

Porto

ZIP/Postal Code

4200319

Country

Portugal

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 2

ZIP/Postal Code

022328

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

State/Province

Jud. Iasi

ZIP/Postal Code

700111

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

030171

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

050098

Country

Romania

Facility Name

Novartis Investigative Site

City

Cluj-Napoca

ZIP/Postal Code

3400

Country

Romania

Facility Name

Novartis Investigative Site

City

Timisoara

ZIP/Postal Code

300 079

Country

Romania

Facility Name

Novartis Investigative Site

City

Kosice

State/Province

Slovak Republic

ZIP/Postal Code

04066

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Bratislava

ZIP/Postal Code

851 07

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Martin

ZIP/Postal Code

03601

Country

Slovakia

Facility Name

Novartis Investigative Site

City

Celje

ZIP/Postal Code

3000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

Novartis Investigative Site

City

Elche

State/Province

Alicante

ZIP/Postal Code

03203

Country

Spain

Facility Name

Novartis Investigative Site

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33006

Country

Spain

Facility Name

Novartis Investigative Site

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

Facility Name

Novartis Investigative Site

City

Toledo

State/Province

Castilla la Mancha

ZIP/Postal Code

45071

Country

Spain

Facility Name

Novartis Investigative Site

City

Salamanca

State/Province

Castilla y Leon

ZIP/Postal Code

37007

Country

Spain

Facility Name

Novartis Investigative Site

City

Badalona

State/Province

Catalunya

ZIP/Postal Code

08916

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08003

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08036

Country

Spain

Facility Name

Novartis Investigative Site

City

Tarragona

State/Province

Catalunya

ZIP/Postal Code

43005

Country

Spain

Facility Name

Novartis Investigative Site

City

Terrassa

State/Province

Catalunya

ZIP/Postal Code

08221

Country

Spain

Facility Name

Novartis Investigative Site

City

Valencia

State/Province

Comunidad Valenciana

ZIP/Postal Code

46010

Country

Spain

Facility Name

Novartis Investigative Site

City

La Coruna

State/Province

Galicia

ZIP/Postal Code

15006

Country

Spain

Facility Name

Novartis Investigative Site

City

Orense

State/Province

Galicia

ZIP/Postal Code

32005

Country

Spain

Facility Name

Novartis Investigative Site

City

Las Palmas de Gran Canaria

State/Province

Las Palmas de G.C

ZIP/Postal Code

35010

Country

Spain

Facility Name

Novartis Investigative Site

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Novartis Investigative Site

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Novartis Investigative Site

City

Bilbao

State/Province

Pais Vasco

ZIP/Postal Code

48013

Country

Spain

Facility Name

Novartis Investigative Site

City

San Sebastian

State/Province

Pais Vasco

ZIP/Postal Code

20080

Country

Spain

Facility Name

Novartis Investigative Site

City

La Laguna

State/Province

Santa Cruz de Tenerife

ZIP/Postal Code

38320

Country

Spain

Facility Name

Novartis Investigative Site

City

Baracaldo

State/Province

Vizcaya

ZIP/Postal Code

48903

Country

Spain

Facility Name

Novartis Investigative Site

City

Barcelona

ZIP/Postal Code

08041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28041

Country

Spain

Facility Name

Novartis Investigative Site

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Novartis Investigative Site

City

Murcia

ZIP/Postal Code

30008

Country

Spain

Facility Name

Novartis Investigative Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Novartis Investigative Site

City

Göteborg

ZIP/Postal Code

SE-413 45

Country

Sweden

Facility Name

Novartis Investigative Site

City

Huddinge

ZIP/Postal Code

SE-14186

Country

Sweden

Facility Name

Novartis Investigative Site

City

Linköping

ZIP/Postal Code

SE-581 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lulea

ZIP/Postal Code

SE-971 80

Country

Sweden

Facility Name

Novartis Investigative Site

City

Lund

ZIP/Postal Code

SE-221 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Stockholm

ZIP/Postal Code

SE-171 76

Country

Sweden

Facility Name

Novartis Investigative Site

City

Umeå

ZIP/Postal Code

SE-901 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Uppsala

ZIP/Postal Code

SE-751 85

Country

Sweden

Facility Name

Novartis Investigative Site

City

Bern

ZIP/Postal Code

3010

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Chur

ZIP/Postal Code

7000

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Genève

ZIP/Postal Code

1211

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Zurich

ZIP/Postal Code

8091

Country

Switzerland

Facility Name

Novartis Investigative Site

City

Uxbridge

State/Province

London

ZIP/Postal Code

UB8 3NN

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Cardiff

ZIP/Postal Code

CF14 4XW

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Dudley

ZIP/Postal Code

DY1 2HQ

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

London

ZIP/Postal Code

W12 0HS

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Nottingham

ZIP/Postal Code

NG5

Country

United Kingdom

Facility Name

Novartis Investigative Site

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

28522574

Citation

Gullaksen SE, Skavland J, Gavasso S, Tosevski V, Warzocha K, Dumrese C, Ferrant A, Gedde-Dahl T, Hellmann A, Janssen J, Labar B, Lang A, Majeed W, Mihaylov G, Stentoft J, Stenke L, Thaler J, Thielen N, Verhoef G, Voglova J, Ossenkoppele G, Hochhaus A, Hjorth-Hansen H, Mustjoki S, Sopper S, Giles F, Porkka K, Wolf D, Gjertsen BT. Single cell immune profiling by mass cytometry of newly diagnosed chronic phase chronic myeloid leukemia treated with nilotinib. Haematologica. 2017 Aug;102(8):1361-1367. doi: 10.3324/haematol.2017.167080. Epub 2017 May 18.

Results Reference

derived

PubMed Identifier

27006491

Citation

Thielen N, Richter J, Baldauf M, Barbany G, Fioretos T, Giles F, Gjertsen BT, Hochhaus A, Schuurhuis GJ, Sopper S, Stenke L, Thunberg S, Wolf D, Ossenkoppele G, Porkka K, Janssen J, Mustjoki S. Leukemic Stem Cell Quantification in Newly Diagnosed Patients With Chronic Myeloid Leukemia Predicts Response to Nilotinib Therapy. Clin Cancer Res. 2016 Aug 15;22(16):4030-8. doi: 10.1158/1078-0432.CCR-15-2791. Epub 2016 Mar 22.

Results Reference

derived

Learn more about this trial

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

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Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase ('MACS1252)

CML in Chronic Phase

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial