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NCT04258943 · ClinicalTrials.gov registry record · Phase 1
Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia
A Phase 1 study of Accelerated Phase Chronic Myelogenous Leukemia and Chronic Phase Chronic Myelogenous Leukemia, sponsored by Children's Oncology Group.
- Active
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 20
- Study locations
NCT04258943 is a Phase 1 study of Accelerated Phase Chronic Myelogenous Leukemia and Chronic Phase Chronic Myelogenous Leukemia that is active but no longer recruiting, run by Children's Oncology Group. The registered enrollment target is 60 participants, below the 175-participant average among 11 other Accelerated Phase Chronic Myelogenous Leukemia trials with a reported enrollment target (66% lower). The trial reports 20 study locations across 14 states.
The verdict
NCT04258943, a Phase 1 study of Accelerated Phase Chronic Myelogenous Leukemia and Chronic Phase Chronic Myelogenous Leukemia, is active but no longer recruiting, sponsored by Children's Oncology Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Bosutinib
Study Locations (20)
California
- Kaiser Permanente Downey Medical Center - Downey
- Loma Linda University Medical Center - Loma Linda
- Kaiser Permanene-Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital Stanford University - Palo Alto
Florida
- Golisano Children's Hospital of Southwest Florida - Fort Myers
- University of Florida Health Science Center - Gainesville - Gainesville
- Nemours Children's Hospital - Orlando
Alabama
- Children's Hospital of Alabama - Birmingham
Arizona
- Phoenix Childrens Hospital - Phoenix
Arkansas
- Arkansas Children's Hospital - Little Rock
Delaware
- Alfred I duPont Hospital for Children - Wilmington
Hawaii
- Kapiolani Medical Center for Women and Children - Honolulu
Indiana
- Riley Hospital for Children - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2020-07-06 |
| Est. Completion | 2028-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04258943
The ClinicalTrials.gov registry entry for NCT04258943 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 175-participant average among 11 other Accelerated Phase Chronic Myelogenous Leukemia trials with a reported enrollment target (66% lower). The listed sponsor is Children's Oncology Group, which has 342 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Accelerated Phase Chronic Myelogenous Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Bosutinib is the first listed.
NCT04258943 reports 20 study locations spanning 14 distinct geographic areas - top geographies include California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT04258943 about?
NCT04258943 is a clinical study titled "Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemia". 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 on...
What is the current status of trial NCT04258943?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2020-07-06. Estimated completion is 2028-07.
What conditions does trial NCT04258943 study?
This clinical trial studies the following conditions: Accelerated Phase Chronic Myelogenous Leukemia, Chronic Phase Chronic Myelogenous Leukemia, Blastic Phase Chronic Myelogenous Leukemia, Philadelphia Chromosome Positive CML.
What interventions are being tested in trial NCT04258943?
The interventions under investigation include: Bosutinib (DRUG).
Who is sponsoring clinical trial NCT04258943?
This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04258943 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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