Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients.

PHASE2CompletedINTERVENTIONAL
Enrollment

59

Participants

Timeline

Start Date

August 20, 2013

Primary Completion Date

June 1, 2016

Study Completion Date

August 28, 2020

Conditions
Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia
Interventions
DRUG

nilotinib

Nilotinib supplied in 50mg, 150mg, and 200mg capsules. It was administered orally at 230mg/m2, twice daily for up to 66 cycles (1 cycle = 28 days). Dose administration was rounded to the nearest 50mg dose (to a maximum dose of 400mg).

Trial Locations (36)

1094

Novartis Investigative Site, Budapest

10126

Novartis Investigative Site, Torino

10330

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

16147

Novartis Investigative Site, Genova

20900

Novartis Investigative Site, Monza

21231

Johns Hopkins Oncology Center ORA, Baltimore

27599

UNC Chapel Hill, Chapel Hill

28009

Novartis Investigative Site, Madrid

32827

Nemours Childrens Hospital, Orlando

33076

Novartis Investigative Site, Bordeaux

33407

St. Mary's Hospital, West Palm Beach

34093

Novartis Investigative Site, Istanbul

35128

Novartis Investigative Site, Padua

43205

Nationwide Childrens Hospital, Columbus

50200

Novartis Investigative Site, Muang

50589

Novartis Investigative Site, Kuala Lumpur

59000

Novartis Investigative Site, Lille

75019

Novartis Investigative Site, Paris

75235

University of Texas Southwestern Medical Center Oncology, Dallas

76104

Cook Children's Medical Center Oncology, Fort Worth

86021

Novartis Investigative Site, Poitiers

92350

Loma Linda University Cancer Center, Loma Linda

94304

Lucile Salter Packard Children's Hospital at Stanford, Palo Alto

98105

Seattle Childrens Hospital, Seattle

117198

Novartis Investigative Site, Moscow

232-8555

Novartis Investigative Site, Yokohama

606 8507

Novartis Investigative Site, Sakyo Ku

160 8582

Novartis Investigative Site, Shinjuku-ku

330 8777

Novartis Investigative Site, Saitama

420 8660

Novartis Investigative Site, Shizuoka

3015 CE

Novartis Investigative Site, Rotterdam

03080

Novartis Investigative Site, Seoul

06351

Novartis Investigative Site, Seoul

SM2 5PT

Novartis Investigative Site, Sutton

BS2 8BJ

Novartis Investigative Site, Bristol

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY