DIALOG (CAMN107A2203) = Study of the Efficacy and Safety of Oral Nilotinib in CML in Children and Adolescents
Study title
Scientific title
A multi-center, open label, non-controlled phase II study to evaluate efficacy and safety of oral nilotinib in pediatric patients with newly diagnosed Ph+ chronic myelogenous leukemia (CML) in chronic phase (CP) or with Ph+ CML in CP or accelerated phase (AP) resistant or intolerant to either imatinib or dasatinib (EudraCT-Nummer 2013-000200-41; ClinicalTrials.gov NCT01844765)
Type of study
Pediatric trial = Trial in children and adolescents
Current status
No longer recruiting
What is the purpose of the study
This study evaluates the safety, efficacy and concentration of nilotinib over time in in children and adolescents with Philadelphia-positive chronic myelogenous leukemia.
Nilotinib will be administered at 230mg/m2, twice daily for up to 66 cycles (1 cycle = 28 days). Drug will be supplied in 50mg, 150mg,and 200mg capsules. Dose administration will be rounded to the nearest 50mg dose (to a maximum dose of 400mg).
Key inclusion criteria
Children and adolescents between age 1 and 18 can be considered for inclusion in this study if they have newly diagnosed and untreated Philadelphia-positive Chronic Myelogenous Leukemia (Ph+ CML) in chronic phase or Ph+ CML in chronic or accelerated phase and do not respond to or do not tolerate imatinib or dasatinib.
Patients must achieve at least 50 percent on the Karnofsky or Lansky scale. They must also have adequately working kidneys, liver and pancreas.
Key exclusion criteria
Where can I find additional information
Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health
Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)
Study sponsor
Novartis Pharma
Scientific lead / contact
Sabine Hertle
Clinical Trial Head, Novartis
Principal investigator
…
Study centers / principal investigators
Canada
Hospital St. Justine
Quebec, H3T IC5
France
Groupe Hospitalier Pellegrin – Hôpital des Enfants
Bordeaux, Aquitaine, 33076
Hopital Jeanne de Flandre
Lille, 59037
Hopital Robert Debre
Paris, 75019
CHU Hopital Jean Bernard
Poitiers Cedex, 86021
Hungary
SE II.sz. Gyermekklinika
Budapest, 1094
Italy
I.R.C.C.S. Istituto Giannina Gaslini
Genova, 16147
Azienda Ospedaliera di Padova Università degli Studi
Padova, 35128
AO Città della Salute e Scienza-PO Infant. Regina Margherita
Torino, 10126
Japan
Kyoto University Hospital
Kyoto-city, Kyoto, 606-8507
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Saitama Children’s Medical Center
Saitama, 339-8551
Shizuoka Children’s Hospital
Shizuoka, 420-8660
Kanagawa Children’s Medical Centre
Yokohama, Kanagawa, 232-8555
Korea, Republic of
Samsung Medical Center
Seoul, 110-744
Seoul National University Hospital
Seoul, 137-710
Malaysia
Hospital Kuala Lumpur
Netherlands
Erasmus MC
Rotterdam, 3015 CE
Russia
Center of Children’s Hematology n.a. D. Rogachev
Moskow, 117198
Spain
Hospital Niño Jesus
Madrid, 28009
Thailand
Chulalongkorn Hospital
Bangkok, 10330
Siriraj Hospital
Bangkok, 10700
Maharaj Nakhon Chiangmai Hospital
Muang, Chiangmai, 50200
Turkey
Istanbul University Istanbul Medical Faculty
Istanbul, 34093
United Kingdom
Bristol Royal Hospital for Children
Bath, BS2 8BJ
Royal Marsden Hospital
Sutton, SM2 5PT
United States
California
City of Hope National Medical Center
Duarte, CA 91010-3000
Loma Linda University Health
Loma Linda, CA 92350
Miller Children’s Hospital
Long Beach, CA 90806
Kaiser Permanente – California Southern
Los Angeles, CA 90027
Children’s Hospital Los Angeles
Los Angeles, CA 90027
Children’s Hospital Central California
Madera, CA 93636
Lucile Salter Packard Children’s Hospital at Stanford
Palo Alto, CA 94304
Florida
Lee Memorial Health System
Fort Myers, FL 33908
University of Florida
Gainesville, FL 32610
Nemours Children’s Hospital
Orlando, FL 32827
All Children’s Hospital
St. Petersburg, FL 33701
St. Mary’s Hospital
West Palm Beach, FL 33407
Georgia
Memorial Health University Medical Center
Savannah, GA 31404
Illinois
Ann & Robert H. Lurie Children’s Hospital of Chicago
Chicago, IL 60611
University of Chicago
Chicago, IL 60638
Indiana
Riley Hospital for Children
Indianapolis, IN 46142
Maryland
Johns Hopkins Oncology Center
Baltimore, MD 21218
Minnessota
University of Minnesota Medical Center, Fairview
Minneapolis, MN 55455
Mississippi
University of Mississippi Medical Center
Jackson, MS 39216-4505
New Jersey
UMDNJ-Robert Wood Johnson Medical Center
New Brunswick, NJ 08901
St. Joseph’s Childrens Hospital
Paterson, NJ 07503
North Carolina
UNC Chapel Hill
Chapel Hill, NC 08901
Carolinas Medical Center
Charlotte, NC 28203
OhioCincinnati Children’s Hospital Medical Center
Cincinnati, OH 45229-3039
Rainbow Babies & Children’s Hospital
Cleveland, OH 44106-6010
Nationwide Children’s Hospital
Columbus, OH 43205
Tennessee
East Tennessee Children’s Hospital
Knoxville, TN 37931
St. Jude’s Children’s Research Hospital
Memphis, TN 38105
Texas
Dell Children’s Medical Center of Central Texas
Austin, TX 78723
Children’s Medical Center of Dallas
Dallas, TX 75235
Cook Children’s Medical Center
Fort Worth, TX 78723
Utah
Primary Children’s Medical Center
Salt Lake City, UT 84113
Virginia
Children’s Hospital of the King’s Daughters
Norfolk, VA 23507
Washington
Seattle Children’s Hospital
Seattle, Washington, WA 98105
Wisconsin
Midwest Children’s Cancer Center
Milwaukee, WI 53226