BCHILD – Bosutinib in Pediatric Patients [Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Spain, Switzerland, UK, USA]

Type of study

Pediatric trial

Phase

1/2

Current status

Recruiting

Study title

Bosutinib in Pediatric CML Patients

Scientific title

A Phase I/II Study of Bosutinib in Pediatric Patients with Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph+ Chronic Myeloid Leukemia (ClinicalTrials.gov NCT04258943; EudraCT no. 2015-002916-34)

Other trial ID

AAML1921; COG-ITCC-054; NTR5501

What is the purpose of the study

This is a study to identify a recommended dose of bosutinib given orally once daily in pediatric patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia in chronic phase (CML-CP) and in pediatric patients with Ph+ CML who have been treated with at least one tyrosine kinase inhibitor (TKI). The study is designed to also estimate the safety, tolerability and efficacy, and to evaluate the pharmacokinetics of bosutinib in this patient population.

What will happen during the study

Bosutinib is given orally once daily at increasing dose levels to determine the recommended dose level for further investigation.

 

 

Key inclusion criteria

This study includes patients of all sexes who:

  • are 1 year to 18 years old
  • have newly diagnosed chronic myeloid leukemia (CML) in chronic phase (CP) or who are resistant or intolerant to at least one prior tyrosine kinase inhibitor (TKI).
  • have adequate bone marrow, liver and kidney function
  • have a Lansky performance status of at least 50% for patients up to 16 years of age, or a Karnofsky scale of at least 50% for patients over 16 years of age. Lansky performance status and Karnofsky scale are used to assess to what extent patients are able to carry on normal activities.

Key exclusion criteria

This study does not include patients:

  • with a known history of the T315I or V299L BCR-ABL1 mutations at the time of study entry
  • who have received treatment with a TKI within 7 days prior to starting bosutinib treatment, or other antitumor or anti-leukemia treatment within 14 days prior to starting bosutinib treatment (hydoxyurea and/or anagrelide prior to starting bosutinib are allowed)
  • who have undergone allogeneic stem cell transplantation within 3 months prior to bosutinib treatment.

Further criteria may apply. Please discuss these with your doctor or study staff.

Estimated primary completion date

December 2023

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

Erasmus Medical Centre, Rotterdam, and Children’s Oncology Group (for USA sites) with support from Pfizer

Scientific lead / contact

Prof. Dr. CM Zwaan
Erasmus Medical Centre
Rotterdam, Netherlands

Principal investigator

Prof. Dr. CM Zwaan
Erasmus Medical Centre
Rotterdam, Netherlands

For USA:
Dr. Hijiya
Columbia University Irving Medical Center
New York, N.Y.

Study centers / principal investigators

Denmark

Rigshospitalet
Dr. Karsten Nysom
2100 Copenhagen


France

Institut d’hématologie et d’oncologie pédiatrique- IHOP
Dr. Yves Bertrand
69008 Lyon

Hôpital Mère-Enfant, CHU de Nantes,
Dr. Fanny Rialland
44093 Nantes Cedex 01

Hôpital Armand Trousseau
Dr. Petit
75012 Paris

Hôpital Robert Debré
Dr. Brethon
75019 Paris


Germany

Universitätsklinikum Erlangen
Prof. Dr. Markus Metzler
91054 Erlangen

Universitätsklinikum Essen
Dr. Reinhardt
Hufelandstrasse 55
45147 Essen


Ireland

Our Lady’s Children’s Hospital Crumlin
Dr. Owen Smith
Crumlin, Dublin 12


Israel

Sheba – Academic Medical Center Hospital
Dr. Bella Bielorai
Tel Hashomer, 52621


Italy

Clinica Pediatrica universita’ Milano Bicocca, Fondazione MBBM
Dr. Carmelo Rizzari
20900 Monza

Ospedale pediatrico bambino gesu’
Dr. Locatelli
Piazza S.Onofrio, 4, Rome

Regina Margherita Children’s Hospital
Dr. Bertorello
Piazza Polonia 94, 10126 Torino


Netherlands

Erasmus MC
Prof. Dr. CM Zwaan
3015GN Rotterdam

Princess Maxima center for pediatric oncology
Dr. Inge van der Sluis
3584 CS Utrecht


Spain

Hospital Universitari Vall d’Hebron
Dr. P. Velasco
08035 Barcelona

Hospital Niño Jesus
Dr. Francisco Bautista
28009 Madrid


Switzerland

Universitäts-Kinderspital Zürich
Dr. J.P. Bourquin
8032 Zurich


United Kingdom

Birmingham Children’s Hospital
Dr. Motwani
Steelhouse Lane, Birmingham, B4 6NH

The Royal Marsden NHS Foundation Trust Hospital
Dr. Donna Lancaster
Sutton, Surrey, SM2 5PT


United States

Alabama

Children’s Hospital of Alabama
Birmingham, Alabama, 35233
Contact: Matthew Kutny, MD

Arizona

Phoenix Childrens Hospital
Phoenix, Arizona, 85016
Principal Investigator: Jessica Boklan, MD

Arkansas

Arkansas Children’s Hospital
Little Rock, Arkansas, 72202-3591
Principal Investigator: David Becton, MD

California

Kaiser Permanente Downey Medical Center
Downey, California, 90242
Principal Investigator: Robert Cooper, MD

Loma Linda University Medical Center
Loma Linda, California, 92354
Principal Investigator: Albert Kheradpour, MD

Kaiser Permanente-Oakland
Oakland, California, 94611
Principal investigator: Laura Campbell, MD

Children’s Hospital of Orange County
Orange, California, 92868
Principal investigator: Elyssa Rubin, MD

Lucile Packard Children’s Hospital Stanford University
Palo Alto, California, 94304
Contact: Jay Balagtas, MD

Delaware

Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Principal Investigator: Emi Caywood, MD

Florida

Golisano Children’s Hospital of Southwest Florida
Fort Myers, Florida, 33908
Principal Investigator: Emad Salman, MD

University of Florida Health Science Center – Gainesville
Gainesville, Florida, 32610
Principal Investigator: William Slayton, MD

Nemours Children’s Hospital
Orlando, Florida, 32827
Principal Investigator: Ramamoorthy Nagasubramanian, MD

Hawaii

Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Principal Investigator: Wade T. Kyono

Indiana

Riley Hospital for Children
Indianapolis, 46202
Principal Investigator: Sandeep Batra, MD

Iowa

Blank Children’s Hospital
Des Moines, Iowa, 50309
Principal Investigator: Samantha Mallory, MD

Kentucky

Norton Children’s Hospital
Louisville, Kentucky, 40202
Principal Investigator: Ashok Raj, MBBS MD

Massachusetts

Dana-Farber/Harvard Cancer Center
Boston, Massachusetts, 02215
Principal Investigator: Suzanne Shusterman, MD

Missouri

Children’s Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Principal Investigator: Keith August, MD MSc

Nevada

Children’s Specialty Center of Nevada II
Las Vegas, Nevada, 89109
Principal Investigator: Alan Ikeda

New Jersey

Hackensack University Medical Center
Hackensack, New Jersey, 07601
Principal Investigator: Burton Appel, MD

Morristown Medical Center
Morristown, New Jersey, 07960
Principal Investigator: John Gregory, MD

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08903
Principal Investigator: Richard A. Drachtman, MD

New York

Roswell Park Cancer Institute
Buffalo, New York, 14263
Contact: Clare J Twist, MD

The Steven and Alexandra Cohen Children’s Medical Center of New York
New Hyde Park, New York, 11040
Principal Investigator: Arlene Redner, MD

North Carolina

Carolinas Medical Center/Levine Cancer Institute
Charlotte, 28203
Principal Investigator: Joel Kaplan, DO MPH

Ohio

Children’s Hospital Medical Center of Akron
Akron, Ohio, 44308
Contact: Steven Kuerbitz, MD

Cincinnati Children’s Hospital Medical Center
Cincinnati, Ohio, 45229
Principal Investigator: Robin Norris, MD MPH

Rainbow Babies and Childrens Hospital
Cleveland, Ohio, 44106
Contact: Duncan Stearns, MD

Nationwide Children’s Hospital
Columbus, Ohio, 43205
Contact: Mark A Rinalli, MD

Pennsylvania

Lehigh Valley Hospital-Cedar Crest
Bethlehem, Pennsylvania, 18017
Principal Investigator: Jacob Troutman, DO

Children’s Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Contact: Frank Balis, MD

Children’s Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Principal Investigator: Andrew Bukowinski, MD

Rhode Island

Rhode Island Hospital
Providence, Rhode Island, 02903
Contact: Jennifer Greene Welch, MD

Tennessee

East Tennessee Childrens Hospital
Knoxville, 37916
Principal Investigator: Susan Spiller, MD

Saint Jude Children’s Research Hospital
Memphis, Tennessee, 38105
Principal Investigator: Alberto Pappo, MD

Vanderbilt University/Ingram Cancer Center
Nashville, 37232
Principal Investigator: Scott Borinstein, MD PhD

Texas

Dell Children’s Medical Center of Central Texas
Austin, Texas, 78723
Principal Investigator: Shannon Cohn, MD

UT Southwestern/Simmons Cancer Center
Dallas, Texas, 75235-9063
Principal investigator: Patrick Leavey, MD

M D Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator: Pooja Hingorani, MD

Virginia

Inova Fairfax Hospital
Falls Church, Virginia, 22042
Principal Investigator: Robin Dulman, MD

Children’s Hospital of The Kings Daughters
Norfolk, Virginia, 23507
Principal investigator: Eric Lowe, MD

Washington

Seattle Children’s Hospital
Seattle, Washington, 98105
Principal Investigator: Sarah Leary, MD

Wisconsin

Children’s Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Principal Investigator: Paul Harker-Murray, MD PhD