Study of Bosutinib for Children with Newly Diagnosed or Resistant Chronic Myeloid Leukemia

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called Chronic Myeloid Leukemia (CML) in children. The study is testing a medication called Bosutinib, which is a type of drug known as a tyrosine kinase inhibitor. Tyrosine kinase inhibitors work by blocking certain proteins that help cancer cells grow. The trial involves children who have either been newly diagnosed with CML or have CML that is resistant or intolerant to previous treatments.

The purpose of the study is to find the best dose of Bosutinib for children with CML and to understand how the drug behaves in their bodies. The study will also look at the safety and side effects of the medication. Participants will take the medication in the form of capsules or film-coated tablets, which are taken by mouth. The study will be conducted in two phases. In the first phase, different doses of the medication will be tested to find the most suitable one. In the second phase, the study will focus on how the medication is processed in the body and its overall safety.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the medication. The study aims to gather information that could help improve treatment options for children with Chronic Myeloid Leukemia. Participants will be closely monitored for any side effects or changes in their condition, and the information collected will contribute to understanding the effectiveness and safety of Bosutinib in treating this type of leukemia in children.

1 introduction to the trial

The trial involves the use of bosutinib, a medication taken orally in the form of capsules or film-coated tablets.

The study is designed for pediatric patients with chronic myeloid leukemia (CML), specifically those newly diagnosed or resistant/intolerant to previous treatments.

2 phase 1: dosage determination

The initial phase focuses on determining the recommended dose of bosutinib for pediatric patients.

This involves monitoring the body’s response to the medication, including how it is absorbed and processed.

3 phase 1: safety assessment

During this phase, the occurrence and severity of any side effects are closely monitored.

The goal is to ensure the medication is safe and well-tolerated at various dose levels.

4 phase 2: effectiveness evaluation

The second phase assesses the effectiveness of bosutinib at the determined dose.

This includes measuring the medication’s impact on the disease and any improvements in health.

5 phase 2: long-term monitoring

Patients are monitored over time to evaluate the duration of the medication’s effects.

This phase also examines overall survival rates and any long-term side effects.

6 completion of the trial

The trial is expected to conclude by March 2029.

Final results will provide insights into the safety and effectiveness of bosutinib for treating pediatric CML.

Who Can Join the Study?

Patients must have a confirmed diagnosis of Philadelphia chromosome-positive Chronic Myeloid Leukemia (CML), which is a specific type of leukemia.
For girls who have started menstruating, a pregnancy test must be negative at the start of the study.
Patients who can have children must agree to use a very effective form of birth control during the study and for at least 30 days after the last dose of the study medication.
Written consent must be provided by the patient’s parents or legal guardians, and by the patients themselves if they are old enough, according to local laws.
Patients and their guardians must be willing and able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
Patients must be between the ages of 1 and 18 years old at the time of giving consent.
Patients must have a performance status score of at least 50%, which measures their ability to perform daily activities.
Patients must have adequate kidney function, which means their kidneys are working well enough to filter waste from the blood.
Patients must have adequate liver function, meaning their liver is working well enough to process substances in the body.
Patients must have recovered from any side effects of previous treatments, except for hair loss.
Patients must be able to swallow pills or take the medication mixed with food or dissolved in water.
For patients who have been treated with other medications before, they must have shown resistance or intolerance to at least one previous treatment. Resistance means the treatment did not work well, and intolerance means they could not take the treatment due to side effects.
For newly diagnosed patients, they must have been diagnosed with CML within the last 6 months and not have received any previous treatment for CML, except for specific medications like hydroxyurea or anagrelide.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Chronic Myeloid Leukemia (CML) cannot participate. CML is a type of blood cancer.
Patients who are not within the specified age range for the study cannot participate. The study is for pediatric patients, which means it is for children.
Patients who are not resistant or intolerant to previous TKI therapy cannot participate. TKI therapy refers to a type of treatment using drugs called tyrosine kinase inhibitors, which are used to treat certain cancers.
Patients who have not been newly diagnosed with CML or are not in the chronic phase of CML cannot participate. The chronic phase is the early stage of CML.
Patients who are not able to safely take the study medication, bosutinib, due to other health conditions or medications cannot participate. Bosutinib is a drug used to treat CML.
Patients who are not able to follow the study procedures or attend study visits cannot participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Fondazione IRCCS San Gerardo Dei Tintori	Monza	Italy
Ospedale Pediatrico Bambino Gesu’	Rome	Italy
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Eivbzso Uepgrbekevow Mgjzyoq Ctmzdfe Rpbctiedm (frrqbtq Mzx	Rotterdam	The Netherlands
Avmfpkz Oouxxgvzmog Ufnvevlhhmdwh Ckranziyknya Dxfoq Sswcao E Dctbc Sfaczyv Dm Tpvwxk	Turin	Italy
Hopdcvzd Vpej dtbnzffg	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.02.2016
Germany	Not recruiting	01.02.2016
Italy	Not recruiting	01.02.2016
Spain	Not recruiting	01.02.2016
The Netherlands	Not recruiting	01.02.2016

Trial locations

Investigated drugs:

Bosutinib

Bosutinib is a medication being studied for its effectiveness in treating pediatric patients with chronic myeloid leukemia (CML). This trial focuses on children who have either newly diagnosed chronic phase CML or have shown resistance or intolerance to previous treatments. The study aims to determine the appropriate dose of Bosutinib for these patients by evaluating how the drug is processed in the body, as well as its safety and tolerability.

Chronic Myeloid Leukemia – Chronic Myeloid Leukemia (CML) is a type of cancer that affects the blood and bone marrow. It is characterized by the overproduction of white blood cells, which can crowd out healthy blood cells. CML typically progresses slowly and may not cause noticeable symptoms in its early stages. As the disease advances, it can lead to fatigue, weight loss, and an enlarged spleen. The progression of CML is often divided into three phases: chronic, accelerated, and blast crisis, with each phase indicating a more severe stage of the disease. The chronic phase is the initial stage, where symptoms are mild, while the blast crisis phase is more severe and resembles acute leukemia.

Trial ID:

2023-504311-32-00

Protocol code:

ITCC-054/AAML1921

NCT ID:

NCT04258943

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Bosutinib for Children with Newly Diagnosed or Resistant Chronic Myeloid Leukemia

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