coiaward2010

CAMN107A2203 = Study of the Efficacy and Safety of Oral Nilotinib in CML in Children and Adolescents

Study title

CAMN107A2203 = Open Label, Phase II Study to Evaluate Efficacy and Safety of Oral Nilotinib in Philadelphia Positive (Ph+) Chronic Myelogenous Leukemia (CML) Pediatric Patients [Asia, Europe, North America]

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)

Indication and most important 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.

Short description of intervention

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).

Type of study

Pediatric trial = Trial in children and adolescents

Current status

No longer recruiting

Study sponsor

Novartis Pharma

Scientific lead / contact

Sabine Hertle
Clinical Trial Head, Novartis

Principal investigator

...

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 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