Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Accelerated Phase Chronic Myelogenous Leukemia and Chronic Phase Chronic Myelogenous Leukemia, sponsored by Children's Oncology Group.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Data from Phase 1; Dose-limiting toxicities determined as adverse events occurring in the first cycle (28 days) of treatment, which are attributable to bosutinib. Assessment will be done according the following DLT definition: * Non-hematologic AEs: grade ≥3 toxicities, except those that have not been optimally treated; any grade ≥2 toxicity requiring discontinuation/interruption for ≥7 days during the first 28 days of treatment; clinically significant laboratory abnormalities grade ≥3 or lasti
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 |
What the registry record for NCT04258943 still lists
NCT04258943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 175-participant average among 11 other Accelerated Phase Chronic Myelogenous Leukemia trials with a reported enrollment target (66% lower).
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 names 20 study sites across 14 states, led by 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.
Learn More About Clinical Trials
Similar trials for Accelerated Phase Chronic Myelogenous Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04258943's enrollment target sits among peer trials
60 6th of 11 higher than 6 of 11 other Accelerated Phase Chronic Myelogenous Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Accelerated Phase Chronic Myelogenous Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Chemotherapy Plus Sargramostim in Treating Patients With Refractory Myeloid Cancer
COMPLETED · Phase 1
-
A Pilot Study to Evaluate the Co-Infusion of Ex Vivo Expanded Cord Blood Cells With an Unmanipulated Cord Blood Unit in Patients Undergoing Cord Blood Transplant for Hematologic Malignancies
COMPLETED · Phase 1
-
Infection Prophylaxis and Management in Treating Cytomegalovirus (CMV) Infection in Patients With Hematologic Malignancies Previously Treated With Donor Stem Cell Transplant
ACTIVE NOT RECRUITING
-
Lithium Carbonate in Treating Patients With Acute Intestinal Graft-Versus-Host-Disease (GVHD) After Donor Stem Cell Transplant
COMPLETED · NA
-
Infusion of Off-the-Shelf Expanded Cord Blood Cells to Augment Cord Blood Transplant in Patients With Hematologic Malignancies
COMPLETED · Phase 2
-
Imatinib Mesylate and Decitabine in Treating Patients With Chronic Myelogenous Leukemia
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00576069 · 60 participants
Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma
- NCT01297400 · 60 participants · Phase 2
Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns
- NCT01734122 · 60 participants
Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor
- NCT01804634 · 60 participants · Phase 2
Reduced Intensity Haploidentical BMT for High Risk Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI