Study on Bosutinib for Children with Newly Diagnosed or Resistant Chronic Myeloid Leukemia
Sponsor: Children's Oncology Group
ClinicalTrials ID:NCT04258943
This clinical trial is testing the safety and effectiveness of the drug bosutinib in children with chronic myeloid leukemia (CML) who are either newly diagnosed or have not responded well to previous treatments.
Patient Parameters
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Program Overview
This study aims to find the best dose of bosutinib for children with chronic myeloid leukemia (CML) who are either newly diagnosed or have not responded to previous treatments. The trial will assess how safe and effective bosutinib is for these patients and will also study how the drug behaves in the body.
Description
The study is divided into two phases. In Phase 1, researchers will determine the safest dose of bosutinib for children with CML who have not responded to previous treatments. This phase will help identify any side effects and how the drug is processed in the body. In Phase 2, the study will include children who are newly diagnosed with CML and those who have not responded to previous treatments. The goal is to see how well bosutinib works in controlling the disease.
Participants will take bosutinib orally once a day. The study will monitor the safety and effectiveness of the treatment, as well as how the drug is absorbed and processed in the body. Children will be closely observed for any side effects and their response to the treatment.
The study is open to children aged 1 to 18 years who meet specific health criteria. Participants must be able to swallow pills or take the medication mixed with food or dissolved in water. They must also agree to use effective birth control methods if they are of childbearing age.
Eligibility Criteria
Inclusion Criteria
- Children aged 1 to 18 years with a diagnosis of chronic myeloid leukemia (CML) that is either newly diagnosed or has not responded to previous treatments.
- Must have specific genetic markers associated with CML.
- Must have adequate bone marrow, kidney, and liver function.
- Must be able to swallow pills or take the medication in a suitable form.
- Must not be pregnant and agree to use effective birth control if of childbearing age.
- Must be willing to comply with study visits and procedures.
Exclusion Criteria
- Children with a different type of leukemia or certain genetic mutations.
- Children who have received certain treatments or medications recently.
- Children with significant heart problems or other serious health conditions.
- Children who are pregnant or breastfeeding.
- Children with active infections or other medical conditions that could interfere with the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital of Alabama | 35233 | Birmingham | Alabama |
| Phoenix Childrens Hospital | 85016 | Phoenix | Arizona |
| Arkansas Children's Hospital | 72202-3591 | Little Rock | Arkansas |
| Kaiser Permanente Downey Medical Center | 90242 | Downey | California |
| Loma Linda University Medical Center | 92354 | Loma Linda | California |
| Kaiser Permanene-Oakland | 94611 | Oakland | California |
| Children's Hospital of Orange County | 92868 | Orange | California |
| Lucile Packard Children's Hospital Stanford University | 94304 | Palo Alto | California |
| Alfred I duPont Hospital for Children | 19803 | Wilmington | Delaware |
| Golisano Children's Hospital of Southwest Florida | 33908 | Fort Myers | Florida |
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