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

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIBiomarker/Laboratory analysis, TreatmentActive18 and underPharmaceutical / IndustryCAMN107A2203
NCT01844765

Trial Description

Summary

To evaluate the safety, efficacy and concentration of nilotinib over time in the Ph+ chronic myelogenous leukemia (CML) in pediatric patients (from 1 to <18 years).

Eligibility Criteria

Inclusion Criteria:

  • Newly diagnosed and untreated Ph+ CML CP or Ph+ CML CP or AP resistant or intolerant to either imatinib or dasatinib
  • Karnofsky or Lansky ≥ 50
  • Adequate renal, hepatic and pancreatic function
  • Potassium, magnesium, phosphorus and total calcium values ≥ LLN (lower limit of normal)
  • Written informed consent

Exclusion Criteria:

  • Treatment with strong CYP3A4 inhibitors or inducers
  • Use or planned use of any medications that have a known risk or possible risk to prolong the QT interval
  • Acute or chronic liver, pancreatic or severe renal disease
  • History of pancreatitis or chronic pancreatitis.
  • Impaired cardiac function
  • No evidence of active graft vs host and <3mo since Stem Cell Transplant
  • Total body irradiation (TBI) or craniospinal radiation therapy <6months
  • Hypersensitivity to the active ingredient or any of the excipients including lactose.
  • Other protocol-defined inclusion/exclusion criteria.

Trial Contact Information

Trial Lead Organizations/Sponsors

Novartis Pharmaceuticals Corporation

  • Children's Oncology Group
  • Innovative Therapies for Children with Cancer
Novartis Pharmaceuticals, Study Director
Novartis Pharmaceuticals
Ph: 1-888-669-6682

Trial Sites

U.S.A.

California
Duarte

City of Hope Comprehensive Cancer Center

Contact Person
Ph: 626-256-4673Ext. 64200

Anna Pawlowska
Principal Investigator

Loma Linda

Loma Linda University Health Oncology

Contact Person
Ph: 909-558-7428

Antranik Bedros
Principal Investigator

Los Angeles

Children's Hospital Los Angeles

Contact Person
Ph: 323-361-2225

Cecilia H. Fu
Principal Investigator

Madera

Children's Hospital Central California

Contact Person
Ph: 559-353-5480

J Daniel Ozeran
Principal Investigator

Palo Alto

Lucile Salter Packard Children's Hospital at Stanford

Contact Person
Ph: 650-723-5117

Neyssa Marina
Principal Investigator

San Diego

Kaiser Permanente - California Southern Onc

Contact Person
Ph: 323-783-5307

Robert Cooper
Principal Investigator

Florida
Fort Myers

Lee Cancer Care of Lee Memorial Health System

Contact Person
Ph: 239-343-5333

Emad Salman
Principal Investigator

Gainesville

UF Health Cancer Center

Contact Person
Ph: 352-273-9120

William Slayton
Principal Investigator

Orlando

Nemours Children's Hospital

Contact Person
Ph: 407-234-1740

Ramamoorthy Nagasubramanian
Principal Investigator

St. Petersburg

All Children's Hospital

Contact Person
Ph: 727-767-4176

Gregory Hale
Principal Investigator

West Palm Beach

Kaplan Cancer Center at St. Mary's Medical Center

Virupakshapu Narayana-Gowda
Principal Investigator

Georgia
Savannah

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Contact Person
Ph: 912-350-8603

Martin Johnston
Principal Investigator

Illinois
Chicago

Ann and Robert H. Lurie Children's Hospital of Chicago

Contact Person
Ph: 312-227-4855

Nobuko Hijiya
Principal Investigator

Indiana
Indianapolis

Riley's Children Cancer Center at Riley Hospital for Children

Contact Person
Ph: 317-948-1269

Robert Fallon
Principal Investigator

Maryland
Baltimore

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Contact Person
Ph: 410-955-8817

Patrick Brown
Principal Investigator

Minnesota
Minneapolis

University of Minnesota Medical Center, Fairview Oncology

Peter Gordon
Principal Investigator

Mississippi
Jackson

University of Mississippi Medical Center Peds Heme/Onc

Contact Person
Ph: 601-984-5220

Gail Megason
Principal Investigator

New Jersey
New Brunswick

UMDNJ-Robert Wood Johnson Medical Center Oncology

Contact Person
Ph: 732-235-6096

Richard DRACHTMAN
Principal Investigator

North Carolina
Chapel Hill

UNC Chapel Hill

Contact Person
Ph: 919-966-0985

Stuart Gold
Principal Investigator

Charlotte

Blumenthal Cancer Center at Carolinas Medical Center

Contact Person
Ph: 704-355-3959

Joel Kaplan
Principal Investigator

Ohio
Cincinnati

Cincinnati Children's Hospital Medical Center Cin. Children's Hosp Med Ctr

Maureen O Brien
Principal Investigator

Cleveland

Rainbow Babies & Children's Hospital RB&C 340

Contact Person
Ph: 216-844-3345

Yousif Matloub
Principal Investigator

Columbus

Nationwide Children's Hospital

Contact Person
Ph: 614-722-4360

Mark Ranalli
Principal Investigator

Tennessee
Knoxville

East Tennessee Children's Hospital

Contact Person
Ph: 865-541-8266

Ray Pais
Principal Investigator

Memphis

St. Jude Children's Research Hospital

Contact Person
Ph: 901-595-4616

Patrick Campbell
Principal Investigator

Texas
Austin

Dell Children's Medical Center of Central Texas

Sharon Lockhart
Principal Investigator

Dallas

Children's Medical Center of Dallas Oncology

Contact Person
Ph: 214-648-2912

Theodore Laetsch
Principal Investigator

Fort Worth

Cook Children's Medical Center - Fort Worth

Contact Person
Ph: 682-885-4007

Kenneth Heym
Principal Investigator

Utah
Salt Lake City

Primary Children's Medical Center

Contact Person
Ph: 801-588-3328

Phillip Barnette
Principal Investigator

Virginia
Norfolk

Children's Hospital of The King's Daughters

Contact Person
Ph: 757-668-9026

Eric Lowe
Principal Investigator

Wisconsin
Milwaukee

Midwest Children's Cancer Center at Children's Hospital of Wisconsin

Michael Kelly
Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifier NCT01844765
ClinicalTrials.gov processed this data on May 25, 2015

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.