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Tyrosine Kinase Inhibitor

Bosutinib for Chronic Myeloid Leukemia

Phase 1 & 2
Waitlist Available
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adequate renal function with calculated creatinine clearance ≥ 60mL/min/1.73 m2
Cytogenetic and molecular diagnosis of Philadelphia chromosome-positive CML at either time of initial CML diagnosis or at time of study screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, a maximum of around 10 years
Awards & highlights

Study Summary

This trial is testing a new leukemia drug in children. The goal is to find a safe dose and to see if the drug works.

Who is the study for?
This trial is for pediatric patients aged 1-18 with newly diagnosed chronic phase Philadelphia chromosome-positive Chronic Myeloid Leukemia (Ph+ CML) or those resistant/intolerant to prior treatments. Participants must have proper bone marrow, kidney and liver function, not be pregnant, able to swallow medication whole, and willing to use effective contraception if applicable.Check my eligibility
What is being tested?
The study tests the drug Bosutinib in children with Ph+ CML. It's an open-label trial meaning everyone knows what treatment they're getting. The goal is to find a safe dose for kids who are either newly diagnosed or haven't responded well to previous therapies and see how their bodies handle the drug.See study design
What are the potential side effects?
While specific side effects for this pediatric trial aren't listed, Bosutinib can generally cause stomach issues like diarrhea, nausea; liver problems; rash; fatigue; muscle pain; and changes in blood test results which could indicate other potential side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidneys are working well.
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My leukemia is Philadelphia chromosome-positive.
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I am not pregnant.
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I have had a bad reaction or no response to a previous cancer drug treatment.
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I am between 1 and 17 years old.
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My liver functions within the normal range.
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I have recovered from the side effects of my previous treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, a maximum of around 10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, a maximum of around 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
1. Incidence (and severity) of Dose-Limiting Toxicities (DLTs) assessed during the first 28 days of treatment.
AEs, as characterized by type, frequency, severity (as graded using CTCAE version, v4.03), timing, seriousness, and relation to study therapy (pooled across ND and R/I CML patients and by line of therapy).
PK parameters of bosutinib: Apparent clearance (CL/F).
+6 more
Secondary outcome measures
AEs, as characterized by type, frequency, severity (as graded using CTCAE version, v4.03), timing, seriousness, and relation to study therapy;
Duration of the respective responses by line of therapy
ECG abnormalities: PR interval
+9 more
Other outcome measures
Parameters of bone metabolism and growth: bone age
Bone and Bones
Parameters of bone metabolism and growth: hormones associated with growth and pubertal development (IGF-1, T4, TSH and LH, FSH, estradiol for girls, and testosterone for boys)
+7 more

Side effects data

From 2020 Phase 3 trial • 536 Patients • NCT02130557
75%
Diarrhoea
37%
Nausea
36%
Thrombocytopenia
34%
Alanine aminotransferase increased
26%
Aspartate aminotransferase increased
23%
Abdominal pain
23%
Rash
22%
Anaemia
22%
Headache
21%
Vomiting
21%
Lipase increased
21%
Fatigue
18%
Arthralgia
16%
Pyrexia
13%
Constipation
13%
Nasopharyngitis
13%
Asthenia
13%
Upper respiratory tract infection
12%
Back pain
12%
Neutropenia
11%
Decreased appetite
11%
Cough
11%
Dyspnoea
11%
Pruritus
10%
Dyspepsia
10%
Abdominal pain upper
10%
Urinary tract infection
10%
Pain in extremity
10%
Hypertension
9%
Influenza
9%
Amylase increased
9%
Dizziness
7%
Bronchitis
7%
Leukopenia
7%
Oedema peripheral
7%
Blood creatinine increased
7%
Dry skin
7%
Insomnia
6%
Sinusitis
6%
Blood alkaline phosphatase increased
6%
Blood bilirubin increased
6%
Oropharyngeal pain
6%
Alopecia
6%
Lymphopenia
6%
Influenza like illness
6%
Anxiety
5%
Abdominal distension
5%
Blood creatine phosphokinase increased
5%
Toothache
5%
Myalgia
5%
Rash maculo-papular
4%
Gastroenteritis
4%
Muscle spasms
3%
Gastrooesophageal reflux disease
3%
Hypophosphataemia
3%
Bone pain
3%
Pneumonia
3%
Weight increased
3%
Depression
3%
Face oedema
2%
Vision blurred
2%
Hypokalaemia
2%
Night sweats
1%
Pericarditis
1%
Hepatotoxicity
1%
Acute kidney injury
1%
Chronic kidney disease
1%
Hepatitis
1%
Cellulitis
1%
Coronary artery disease
1%
Femoral neck fracture
1%
Respiratory failure
1%
Myocardial ischaemia
1%
Atrial fibrillation
1%
Cholecystitis acute
1%
Musculoskeletal chest pain
1%
Rectal cancer
1%
Pregnancy of partner
1%
Hypertensive crisis
1%
Unintended pregnancy
1%
Haematuria
1%
Pleural effusion
1%
Cardiac failure acute
1%
Periorbital oedema
1%
Eyelid oedema
1%
Conjunctival haemorrhage
1%
Dry eye
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bosutinib
Imatinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Agent BosutinibExperimental Treatment1 Intervention
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). A treatment cycle is defined as 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bosutinib
2015
Completed Phase 3
~2390

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
453 Previous Clinical Trials
237,340 Total Patients Enrolled
Erasmus Medical CenterOTHER
640 Previous Clinical Trials
1,873,155 Total Patients Enrolled
Dutch Childhood Oncology GroupOTHER
7 Previous Clinical Trials
4,481 Total Patients Enrolled

Media Library

Bosutinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04258943 — Phase 1 & 2
Chronic Myeloid Leukemia Research Study Groups: Single Agent Bosutinib
Chronic Myeloid Leukemia Clinical Trial 2023: Bosutinib Highlights & Side Effects. Trial Name: NCT04258943 — Phase 1 & 2
Bosutinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04258943 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the novelty of this research?

"There are a dozen ongoing clinical trials for Bosutinib in 456 cities and 39 nations. The first trial began in 2016 with 150 patients; it was sponsored by Pfizer and completed Phase 1 drug approval in that same year. In the four years since, another 36 studies have been concluded."

Answered by AI

What benefits does this clinical trial hope to bring patients?

"The goal of this trial is to evaluate the PK parameters of bosutinib over a period of AE's will be collected from signing informed consent continuously during the study until 28 days after last dose (on average, 2 years). The secondary outcomes include Time to the respective responses by line of therapy which is defined as Time to response is defined as the time period from start of treatment with bosutinib to first response, unconfirmed for molecular and cytogenetic and confirmed for hematologic. Patients without events are censored at the last molecular, cytogenetic, or hematologic assessment where response could be assessed for the"

Answered by AI

Would I be able to help out with this research project?

"This clinical trial is only accepting patients that have myeloid leukemia, are in the chronic-phase, and between the ages of 1 year old to 18 years old. A total of 60 participants will be allowed into the study."

Answered by AI

Would this experiment be suitable for individuals over the age of 40?

"According to the eligibility criteria for this clinical trial, the minimum age for participation is 1 Year and the maximum age is 18."

Answered by AI

How many test subjects are being given this medication?

"In order to run the trial, 60 patients who meet the inclusion criteria must be recruited. The sponsor, Pfizer, will manage the trial from different sites including Rhode island Hospital in Providence and Children's Mercy Hospitals and Clinics in Kansas City."

Answered by AI

Are there any prior case studies of Bosutinib's effects?

"First appearing in 2016 at Neurological Associates of West LA, bosutinib has been the focus of 36 different studies. As of now, there are 12 ongoing investigations being conducted, with a large portion based out of Providence, Rhode island."

Answered by AI

Is this study limited to North American hospitals?

"45 sites are currently involved in the recruitment process for this trial, with locations in Providence, Kansas City, Oakland and other places. If you enroll as a patient, it would be ideal to choose a clinic near to reduce travel inconvenience."

Answered by AI
~31 spots leftby Jul 2028