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

Study title

Bosutinib in Pediatric CML Patients (ITCC-054/COG AAML1921)

Scientific title

A Phase I/II study of Bosutinib in pediatric patients with newly diagnosed chronic phase or resistant/intolerant Ph+ Chronic Myeloid Leukemia,
study ITCC-054/COG AAML1921 (ClinicalTrials.gov NCT04258943; EudraCT no. 2015-002916-34)

Indication and most important inclusion criteria

Pediatric CML patients aged 1 up to 18 years with newly diagnosed chronic phase CML, or patients who are resistant (suboptimal response or failure, as defined by 2013 European Leukemia Net guidelines) or intolerant (with or without suboptimal response or failure) to at least one prior tyrosine kinase inhibitor (TKI).

To be included, patients need to have adequate renal, liver and heart function as well as 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.

Short description of intervention

In this dose-finding study, the recommended dose of bosutinib will be determined based on the safety and tolerability profile of bosutinib.

Type of study

Pediatric trial

Current status

Recruiting

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.

Additional information

Study description in the EU Clinical Trials Register which is hosted by the European Medicines Agency (EMA)

Study description in the Nederlands Trials Register

Study centers / principal investigators

Denmark

Copenhagen:
Rigshospitalet
Dr. Karsten Nysom
2100 Copenhagen

France

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

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

Paris:
Hôpital Armand Trousseau
Dr. Petit
75012 Paris

Hôpital Robert Debré
Dr. Brethon
75019 Paris

Germany

Erlangen:
Universitätsklinikum Erlangen
Prof. Dr. Markus Metzler
91054 Erlangen

Essen:
Universitätsklinikum Essen
Dr. Reinhardt
Hufelandstrasse 55
45147 Essen

Ireland

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

Israel

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

Italy

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

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

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

Netherlands

Rotterdam:
Erasmus MC
Prof. Dr. CM Zwaan
3015GN Rotterdam

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

Spain

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

Madrid:
Hospital Niño Jesus
Dr. Francisco Bautista
28009 Madrid

Switzerland

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


United Kingdom

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

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


United States

Arkansas

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

California

Kaiser Permanente Downey Medical Center
Downey, 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

Children's Hospital of Orange County
Orange, California, 92868
Principal investigator: Jamie Frediani

Florida

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

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

New Jersey

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

Morristown Medical Center
Morristown, 07960
Principal Investigator: John Gregory, 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

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

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

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

Ohio

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

Pennsylvania

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

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

Tennessee
East Tennessee Childrens Hospital
Knoxville, 37916
Principal Investigator: Susan Spiller, 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 Medical Center Simmons Cancer Center
Dallas, Texas, 75235-9063
Principal investigator: Tamra Slone

Virginia

Children's Hospital of Kings Daughters
Norfolk, Virginia, 23507
Principal investigator: Eric Lowe

 

 

 

 

INCB84344-102 = Safety and efficacy of ponatinib for recurrent or refractory leukemias or solid tumors in children [Europe]

Study title

INCB84344-102 = A study evaluating the safety and efficacy of ponatinib for the treatment of recurrent or refractory leukemias or solid tumors in children

Scientific title

An Open-Label, Single-Arm, Phase 1/2 Study Evaluating the Safety and Efficacy of Ponatinib for the Treatment of Recurrent or Refractory Leukemias or Solid Tumors in Pediatric Participants (ClinicalTrials.gov no NCT03934372, EudraCT no. 2018-004878-99)

Indication and most important inclusion criteria

Children up to 18 years old who have histologically or cytologically confirmed diagnosis of the following malignancies:

Phase 1:
Chronic Phase Myeloid Chronic Leukemia (CP-CML), Blast Phase Chronic Myeloid Leukemia (BP-CML), Accelerated Phase Chronic Leukemia (AP-CML) (relapse)
Acute Lymphoblastic Leukemia (ALL)
Acute Myeloid Leukemai (AML)
− Other leukemias
− Lymphoma
− Any other tumors, including tumors of the central nervous system, for which standard therapy is not available or is not indicated.

Phase 2, Group A with CP-CML:
− CP-CML at the time of study entry and must be resistant to or intolerant of at least 1 prior BCR-ABL–targeted TKI therapy or have the T315I kinase domain mutation.
− Must have 1 bone marrow aspirate with documentation of BCR-ABL translocation by conventional cytogenetics, metaphase FISH, or q-PCR performed within 42 days before the first dose of ponatinib.

Phase 2, Group B with other leukemias or solid tumors:
− ALL
− AML
− Other leukemias
− Lymphoma
− Any other tumors, including tumors of the central nervous system (CNS), with mutations of RET, KIT, FGFR, PDGFR, VEGFR, or any other mutations where ponatinib may have biological activity on fresh or archived tumor tissue
− Participants with solid tumors or with lymphoma must have measurable disease by computer tomograohy (CT) or magnetic resonance imageing (MRI)

Other criteria may apply.

Short description of intervention

In Phase 1, this study will determine the maximum tolerated dose and/or recommended dose for Phase 2 of oral ponatinib given once daily in pediatric participants with selected advanced hematologic malignancies or solid tumors.

In Phase 2, the study will be conducted in two groups.

Group A (CP-CML):
The aim of this study is to determine the efficacy of oral ponatinib given once daily in pediatric participants with CP-CML who are resistant or intolerant to at least 1 prior BCR-ABL–targeted TKI therapy or who have the T315I mutation.

Group B (Other Tumors):
The aim of this study is to determine the efficacy of oral ponatinib given once daily in pediatric participants with other selected advanced hematologic malignancies or solid tumors.

Type of study

Pediatric trials

Current status

Recruiting

Study sponsor

Incyte Biosciences International Sàrl
Switzerland

Scientific lead / contact

Peter Langmuir, MD
Incyte Corporation
globalmedinfo@incyte.com

Principal investigator

Multiple

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Belgium

Ghent University Hospital
Gent, 9000


France

Hopital Robert Debre
Paris, 75019

Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021


Italy

Fondazione Irccs Istituto Nazionale Dei Tumori
Milano, 20133

University of Milano Bicocca
Monza, 20900

Ospedale Pediatrico Bambino Gesu IRCCS
Roma, 00165

Azienda Ospedaliero Universitaria Citta Della Salute E Della Scienza
Torino, 10126


Netherlands

Princess Maxima Center For Pediatric Oncology
Utrecht, 03584


Spain

Hospital Nino Jesus
Madrid, 28009

Hospital Universitario de La Paz
Madrid, 28046


Sweden


Karolinska University Hospital Huddinge
Stockholm, Sweden, 14141


United Kingdom


The Royal Marsden Nhs Foundation Trust - Sutton
Sutton, United Kingdom, SM2 5PT

 

AAML18P1 = Stopping TKI in Affecting Treatment-Free Remission in CP CML [Australia, Canada, United States]

Study title

AAML18P1 = Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia

Scientific title

Stopping Tyrosine Kinase Inhibitors in Affecting Treatment-Free Remission in Patients With Chronic Phase Chronic Myeloid Leukemia (ClinicalTrials.gov NCT03817398)

Indication and most important inclusion criteria

To be considered for inclusion in this study, patients

- must have been diagnosed with chronic phase chronic myeloid leukemia (CP CML) before the age of 18 years
- must have histologic confirmation of CP CML at their original diagnosis
- must have received their current tyrosine kinase inhibitor (TKI) for at least 3 consecutive years at the time of enrollment
- and must be in molecular remission (MR) with a BCR-ABL1 level of at least 0.01% as measured using the International Scale (IS) by RQ-PCR for at least 2 consecutive years at the time of enrollment

Other criteria may apply.

Short description of intervention

This is a study to assess how stopping tyrosine kinase inhibitors will affect treatment-free remission in patients with CML in chronic phase.

Patients stop taking tyrosine kinase inhibitors within 10 days of enrollment. They will be closely monitored for 3 years and treatment outcomes, including quality of life, will be reassessed. Patients who lose their molecular remission may restart TKI medication and will also be closely monitored for 3 years.

Type of study

Treatment discontinuation trial
Pediatric trial

Current status

Recruiting

Study sponsor

Children's Oncology Group in collaboration with
National Cancer Institute (NCI)

Scientific lead / contact

Sonali Chaudhury
Children's Oncology Group

Principal investigator

Sonali Chaudhury
Children's Oncology Group

Additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study centers / principal investigators

Australia

Victoria

Monash Medical Center-Clayton Campus
Clayton, 3168
Principal Investigator: Paul J. Wood

Western Australia

Perth, Western 6009
Perth Children's Hospital
Principal Investigator: Marianne B. Phillips


Canada

Nova Scotia

IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Principal Investigator: Craig Erker

Ontario

McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5
Principal Investigator: Uma H. Athale

Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Principal Investigator: Donna L. Johnston

Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Principal Investigator: Oussama A. Abla

Quebec
The Montreal Children's Hospital of the MUHC
Montreal, H3H 1P3
Principal Investigator: Sharon B. Abish

Centre Hospitalier Universitaire Sainte-Justine
Montreal, QH3T 1C5
Principal Investigator: Yvan Samson

Centre Hospitalier Universitaire de Quebec
Quebec, G1V 4G2
Principal Investigator: Bruno Michon


United States

Alabama

Children's Hospital of Alabama
Birmingham, Alabama, 35233
Principal Investigator: Matthew A. Kutny

Arkansas

Arkansas Children's Hospital
Little Rock, Arkansas, 72202-3591
Principal Investigator: David L. Becton

California

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

Valley Children's Hospital
Madera, California, 93636
Principal Investigator: Karen S. Fernandez

Kaiser Permanente-Oakland
Oakland, California, 94611
Principal Investigator: Laura A. Campbell

Colorado

Children's Hospital Colorado
Aurora, Colorado, 80045
Principal Investigator: Anna R. Franklin

Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Denver, 80218
Principal Investigator: Jennifer J. Clark

Delaware

Alfred I duPont Hospital for Children
Wilmington, Delaware19803
Principal Investigator: Scott M. Bradfield

Florida

Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Principal Investigator: Emad K. Salman

Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Principal Investigator: Scott M. Bradfield

University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, 33136
Principal Investigator: Julio C. Barredo

Nicklaus Children's Hospital
Miami, Florida, 33155
Principal Investigator: Enrique A. Escalon

Nemours Children's Hospital
Orlando, Florida, 32827
Principal Investigator: Scott M. Bradfield

Georgia

Children's Healthcare of Atlanta - Egleston
Atlanta, 30322
Principal Investigator: Daniel J. Bergsagel

Illinois

Lurie Children's Hospital-Chicago
Chicago, Illinois, 60611
Principal Investigator: Jenna Rossoff

Saint Jude Midwest Affiliate
Peoria, Illinois, 61637
Principal Investigator: Jaime M. Libes

Indiana

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

Kentucky

University of Kentucky/Markey Cancer Center
Lexington, 40536
Principal Investigator: James T. Badgett

Norton Children's Hospital
Louisville, 40202
Principal Investigator: Ashok B. Raj

Maryland

Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Principal Investigator: Jason M. Fixler

Walter Reed National Military Medical Center
Bethesda, Maryland, 20889-5600
Principal Investigator: Kenneth Lieuw

Massachusetts

Dana-Farber Cancer Institure
Boston, 02215
Principal Investigator: Jessica A. Polland

Michigan

C S Mott Children's Hospital
Ann Arbor, 48109
Principal Investigator: Rajen Mody

Wayne State University/Karmanos Cancer Institute
Detroit, 48201
Principal Investigator: Jeffrey W. Taub

Minnesota

Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, 55404
Principal Investigator: Michael K. Richards

Mississippi

University of Mississippi Medical Center
Jackson, 39216
Principal Investigator: Anderson (Andy) B. Collier

Missouri

Columbia Regional
Columbia, 65201
Principal Investigator: Barbara A. Gruner

Children's Mercy Hospitals and Clinics
Kansas City, 64108
Principal Investigator: Keith J. August

Nebraska

Children's Hospital and Medical Center of Omaha
Omaha, 68114
Principal Investigator: Minnie Abromowitch

University of Nebraska Medical Center
Omaha, 68198
Principal Investigator: Minnie Abromowitch

University of Nebraska Medical Center
Omaha, Nebraska, 68198
Principal Investigator: Minnie Abromowitch

New Jersey

Hackensack University Medical Center
Hackensack, 07601
Principal Investigator: Richard A. Drachtman

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

Saint Joseph's Regional Medical Center
Paterson, 07503
Principal Investigator: Alissa Kahn

New York

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Principal Investigator: Alice Lee

Memorial Sloan Kettering Cancer Center
New York, 10065
Principal Investigator: Christopher J. Forlenza

NYU Winthrop Hospital
Mineola, New York, 11501
Principal Investigator: Chana L. Glasser

University of Rochester
Rochester,14642
Principal Investigator: Angela R. Girvin

North Carolina

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, 27599
Principal Investigator: Stuart H. Gold

Carolinas Medical Center/Levine Cancer Institute
Charlotte, 28203
Principal Investigator: Joel A. Kaplan

Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Principal Investigator: David E. Kram

Ohio

Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Principal Investigator: Steven J. Kuerbitz

Nationwide Children's Hospital
Columbus, 43205
Principal Investigator: Mark A. Ranalli

Oklahoma

University of Oklahoma Health Sciences Center
Oklahoma City, 73104
Principal Investigator: Rene Y. McNall-Knapp

Pennsylvania

Penn State Children's Hospital
Hershey, 17033
Principal Investigator: Lisa M. McGregor

Children's Hospital of Philadelphia
Philadelphia, 19104
Principal Investigator: Richard Aplenc

Children's Hospital of Pittsburgh of UPMC
Pittsburgh, 15224
Principal Investigator: Jean M. Tersak

Rhode Island

Rhode Island Hospital
Providence, 02903
Principal Investigator: Jennifer J. Greene Welch

South Dakota

Sanford USD Medical Center - Sioux Falls
Sioux Falls57117-5134
Principal Investigator: Kayelyn J. Wagner

Tennessee

East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
Principal Investigator: Ray C. Pais

St. Jude Children's Research Hospital
Memphis, 38105
Principal Investigator: Raul C. Ribeiro

Texas

Medical City Dallas Hospital
Dallas, 75230
Principal Investigator: Stanton C. Goldman

UT Southwestern/Simmons Cancer Center-Dallas
Dallas, 75390
Principal Investigator: Tamra L. Slone

Children's Hospital of San Antonio
San Antonio, 78207
Principal Investigator: Timothy C. Griffin

Utah

Primary Children's Hospital
Salt Lake City, 84113
Principal Investigator: Phillip E. Barnette

Virginia

Children's Hospital of The King's Daughters
Norfolk, 23507
Principal Investigator: Eric J. Lowe

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Principal Investigator: Gita V. Massey

Washington

Seattle Children's Hospital
Seattle, 98105
Principal Investigator: Sarah E. Leary

Providence Sacred Heart Medical Center and Children's Hospital
Spokane, 99204
Principal Investigator: Judy L. Felgenhauer

Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
Principal Investigator: Robert G. Irwin

Wisconsin

University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Principal Investigator: Kenneth B. De Santes

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