Treatment-free Remission After Achieving Sustained MR4.5 on Nilotinib (ENESTop)

PHASE2CompletedINTERVENTIONAL
Enrollment

163

Participants

Timeline

Start Date

December 20, 2012

Primary Completion Date

November 26, 2015

Study Completion Date

January 29, 2025

Conditions
Chronic Myeloid Leukemia
Interventions
DRUG

nilotinib

"Nilotinib was dosed by weight or body surface area.~Nilotinib 300 mg BID or 400 mg BID was be administered orally at approximately 12 hour intervals, and must not have been taken with food. The capsules were to be swallowed whole with water.~No food should have been consumed for at least 2 hours before the dose was taken and no additional food should have been consumed for at least one hour after the dose was taken. Patients were also allowed to enter this study on the same dose they were taking prior to study entry. Patients who required permanent dose reduction from their original starting dose were to be allowed to enter this study on the same dose only if the patient maintained this dose for a minimum of 6 months prior to study entry."

Trial Locations (62)

2060

Novartis Investigative Site, Antwerp

3128

Novartis Investigative Site, Box Hill

5000

Novartis Investigative Site, Adelaide

13353

Novartis Investigative Site, Berlin

14467

Novartis Investigative Site, Potsdam

18547

Novartis Investigative Site, Athens

21229

St Agnes Hospital, Baltimore

28006

Novartis Investigative Site, Madrid

28034

Novartis Investigative Site, Madrid

28046

Novartis Investigative Site, Madrid

33076

Novartis Investigative Site, Bordeaux

38043

Novartis Investigative Site, Grenoble

38320

Novartis Investigative Site, San Cristóbal de La Laguna

39008

Novartis Investigative Site, Santander

41013

Novartis Investigative Site, Seville

46107

Indiana Blood and Marrow Institute, Beech Grove

54511

Novartis Investigative Site, Vandœuvre-lès-Nancy

64718

Novartis Investigative Site, Monterrey

67085

Novartis Investigative Site, Strasbourg

68305

Novartis Investigative Site, Mannheim

69373

Novartis Investigative Site, Lyon

74072

Novartis Investigative Site, Heilbronn

89081

Novartis Investigative Site, Ulm

90033

USC Kenneth Norris Comprehensive Cancer Center, Los Angeles

98683

Compass Oncology, Vancouver

125167

Novartis Investigative Site, Moscow

169608

Novartis Investigative Site, Singapore

191024

Novartis Investigative Site, Saint Petersburg

197341

Novartis Investigative Site, Saint Petersburg

2608677

Novartis Investigative Site, Chiba

3109601

Novartis Investigative Site, Haifa

4941492

Novartis Investigative Site, Petah Tikva

5265601

Novartis Investigative Site, Ramat Gan

77555-0144

University of Texas Medical Branch, Galveston

C1221ADC

Novartis Investigative Site, CABA

C1114AAN

Novartis Investigative Site, Buenos Aires

74605-050

Novartis Investigative Site, Goiânia

30130-100

Novartis Investigative Site, Belo Horizonte

20211-030

Novartis Investigative Site, Rio de Janeiro

20231-050

Novartis Investigative Site, Rio de Janiero

90035-003

Novartis Investigative Site, Porto Alegre

13083-970

Novartis Investigative Site, Campinas

L8V 5C2

Novartis Investigative Site, Hamilton

M5G 2M9

Novartis Investigative Site, Toronto

H1T 2M4

Novartis Investigative Site, Montreal

G1J 1Z4

Novartis Investigative Site, Québec

106 76

Novartis Investigative Site, Athens

411 10

Novartis Investigative Site, Larissa

464 8681

Novartis Investigative Site, Nagoya

286-8523

Novartis Investigative Site, Narita

812-8582

Novartis Investigative Site, Fukuoka

830-0011

Novartis Investigative Site, Kurume

010-8543

Novartis Investigative Site, Akita

030 8553

Novartis Investigative Site, Aomori

30-727

Novartis Investigative Site, Krakow

80-952

Novartis Investigative Site, Gdansk

00-791

Novartis Investigative Site, Warsaw

06591

Novartis Investigative Site, Seoul

08916

Novartis Investigative Site, Badalona

03010

Novartis Investigative Site, Alicante

L7 8XP

Novartis Investigative Site, Liverpool

NG5 1PB

Novartis Investigative Site, Nottingham

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY