Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia
Public ClinicalTrials.gov record NCT04258943. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 1-2, multicenter, international, single-arm, open-label study designed to identify a recommended dose of bosutinib administered orally once daily in pediatric patients with newly diagnosed chronic phase Ph+ CML (ND CML) and pediatric patients with Ph+CML who have received at least one prior TKI therapy (R/I CML), to preliminary estimate the safety and tolerability and efficacy, and to evaluate the PK of bosutinib in this patient population.
Study identification
- NCT ID
- NCT04258943
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 60 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 1 Year to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 6, 2020 (Actual)
- Primary completion
- Jul 2028 (Estimated)
- Completion
- Jul 2028 (Estimated)
- Last update posted
- Oct 1, 2026
2020 – 2028
United States locations
- U.S. sites
- 45
- U.S. states
- 25
- U.S. cities
- 44
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | — |
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Arkansas Children's Hospital | Little Rock | Arkansas | 72202-3591 | — |
| Kaiser Permanente Downey Medical Center | Downey | California | 90242 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Kaiser Permanene-Oakland | Oakland | California | 94611 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| Lucile Packard Children's Hospital Stanford University | Palo Alto | California | 94304 | — |
| Alfred I duPont Hospital for Children | Wilmington | Delaware | 19803 | — |
| Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida | 33908 | — |
| University of Florida Health Science Center - Gainesville | Gainesville | Florida | 32610 | — |
| Nemours Children's Hospital | Orlando | Florida | 32827 | — |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| Blank Children's Hospital | Des Moines | Iowa | 50309 | — |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | — |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | — |
| Dana-Farber/Harvard Cancer Center | Boston | Massachusetts | 02215 | — |
| Children's Mercy Hospitals and Clinics | Kansas City | Missouri | 64108 | — |
| Children's Specialty Center of Nevada II | Las Vegas | Nevada | 89109 | — |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | — |
| Morristown Medical Center | Morristown | New Jersey | 07960 | — |
| Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08903 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| The Steven and Alexandra Cohen Children's Medical Center of New York | New Hyde Park | New York | 11040 | — |
| Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | 28203 | — |
| Children's Hospital Medical Center of Akron | Akron | Ohio | 44308 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Rainbow Babies and Childrens Hospital | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Lehigh Valley Hospital-Cedar Crest | Bethlehem | Pennsylvania | 18017 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| East Tennessee Childrens Hospital | Knoxville | Tennessee | 37916 | — |
| Saint Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Dell Children's Medical Center of Central Texas | Austin | Texas | 78723 | — |
| UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | 75390 | — |
| Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center | Houston | Texas | 77030 | — |
| M D Anderson Cancer Center | Houston | Texas | 77030 | — |
| Inova Fairfax Hospital | Falls Church | Virginia | 22042 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04258943, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 1, 2026 · Synced Oct 24, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04258943 live on ClinicalTrials.gov.