Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 6, 2020

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

Conditions
Philadelphia Chromosome Positive CMLAccelerated Phase Chronic Myelogenous LeukemiaBlastic Phase Chronic Myelogenous LeukemiaChronic Phase Chronic Myelogenous Leukemia
Interventions
DRUG

Bosutinib

"Patients with R/I disease are enrolled at a dose of 400 mg/m2 (DL2B) based on tolerability and PK analysis. Once the RP2D for R/I patients (RP2DR/I) is determined in the Phase 1, subsequent patients with R/I disease will be enrolled at the RP2DR/I for this subpopulation for the Phase 2 component of the study (see section 1.6.3 and section 3 for details).~\- Patients with newly diagnosed disease are being enrolled on Phase 2 component only, at RP2DND dose of 300 mg/m2. (see section 1.6.3 and section 3 for details)"

Trial Locations (59)

11040

The Steven and Alexandra Cohen Children's Medical Center of New York, New Hyde Park

14263

Roswell Park Cancer Institute, Buffalo

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

18017

Lehigh Valley Hospital-Cedar Crest, Bethlehem

19104

Children's Hospital of Philadelphia, Philadelphia

19803

Alfred I duPont Hospital for Children, Wilmington

21287

Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore

22042

Inova Fairfax Hospital, Falls Church

23507

Children's Hospital of The King's Daughters, Norfolk

28203

Carolinas Medical Center/Levine Cancer Institute, Charlotte

32610

University of Florida Health Science Center - Gainesville, Gainesville

32827

Nemours Children's Hospital, Orlando

33908

Golisano Children's Hospital of Southwest Florida, Fort Myers

35233

Children's Hospital of Alabama, Birmingham

37232

Vanderbilt University/Ingram Cancer Center, Nashville

37916

East Tennessee Childrens Hospital, Knoxville

38105

Saint Jude Children's Research Hospital, Memphis

40202

Norton Children's Hospital, Louisville

43205

Nationwide Children's Hospital, Columbus

44106

Rainbow Babies and Childrens Hospital, Cleveland

44308

Children's Hospital Medical Center of Akron, Akron

45229

Cincinnati Children's Hospital Medical Center, Cincinnati

46202

Riley Hospital for Children, Indianapolis

50309

Blank Children's Hospital, Des Moines

53226

Children's Hospital of Wisconsin, Milwaukee

64108

Children's Mercy Hospitals and Clinics, Kansas City

75390

UT Southwestern/Simmons Cancer Center-Dallas, Dallas

77030

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center, Houston

M D Anderson Cancer Center, Houston

78723

Dell Children's Medical Center of Central Texas, Austin

85016

Phoenix Childrens Hospital, Phoenix

89109

Children's Specialty Center of Nevada II, Las Vegas

90242

Kaiser Permanente Downey Medical Center, Downey

92354

Loma Linda University Medical Center, Loma Linda

92868

Children's Hospital of Orange County, Orange

94304

Lucile Packard Children's Hospital Stanford University, Palo Alto

94611

Kaiser Permanene-Oakland, Oakland

96826

Kapiolani Medical Center for Women and Children, Honolulu

98105

Seattle Children's Hospital, Seattle

72202-3591

Arkansas Children's Hospital, Little Rock

02215

Dana-Farber/Harvard Cancer Center, Boston

07601

Hackensack University Medical Center, Hackensack

07960

Morristown Medical Center, Morristown

08903

Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital, New Brunswick

02903

Rhode Island Hospital, Providence

Unknown

CHU Lyon/Hospices Civils de Lyon, Lyon

Hopital Armand Trousseau, Paris

Hopital Robert Debré, Paris

Universitätsklinikum Erlangen, Erlangen

San Gerardo Hospital, Monza

Ospedale Pediatrico Bambino Gesu, Rome

Ospedale Regina Margerita, Torino

Erasmus Medical Center - Sophia Children's Hospital, Rotterdam

Prinses Maxima centrum voor kinderoncologie, Utrecht

Hospital Universitari Vall d'Hebron, Barcelona

Hospital Niño Jesús, Madrid

University Children's Hospital, Zurich

Birmingham Children's Hospital, Birmingham

The Royal Marsden NHS Foundation Trust, London

Sponsors
All Listed Sponsors
collaborator

Erasmus Medical Center

OTHER

collaborator

Dutch Childhood Oncology Group

OTHER

collaborator

Innovative Therapies for Children with Cancer

UNKNOWN

collaborator

Pfizer

INDUSTRY

lead

Children's Oncology Group

NETWORK

NCT04258943 - Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia | Biotech Hunter | Biotech Hunter