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

Study title

Bosutinib in Pediatric CML Patients

Scientific title

A phase I/II study of bosutinib in pediatric patients with Chronic Myeloid Leukemia who are resistant or intolerant to at least one prior Tyrosine Kinase Inhibitor therapy (EudraCT no. 2015-002916-34)

Indication and most important inclusion criteria

Pediatric CML patients aged 1 up to 18 years 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 bone marrow, 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, 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

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
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

Germany
Universitätsklinikum Erlangen
Prof. Dr. Markus Metzler
91054 Erlangen

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

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

Spain
Hospital Niño Jesus
Dr. Francisco Bautista
28009 Madrid

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

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

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

 

 

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, PGFR, 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

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

UZ Gent
Gent, 9000


Spain

Hospital Universitario La Paz - PPDS
Madrid, 28046

Recruitment of patients is also planned in Denmark, France, Germany, Italy, the Netherlands, Sweden and the United Kingdom.

 

AAML18P1 = Stopping TKI in Affecting Treatment-Free Remission in CP CML [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 with at least a MR4 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

Canada

Nova Scotia

IWK Health Centre
Halifax, B3K 6R8
Principal Investigator: Conrad V. Fernandez


United States

Alabama

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

Arkansas

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

California

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

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

Colorado

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

Children's Hospital Colorado
Aurora, 80045
Principal Investigator: Laura A. Campbell

Florida

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

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

Georgia

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

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

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

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

New Jersey

Hackensack University Medical Center
Hackensack, 07601
Principal Investigator: Jing Chen

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

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

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

North Carolina

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

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

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

Washington

Seattle Children's Hospital
Seattle, 98105
Principal Investigator: Douglas S. Hawkins

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

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