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Bosutinib for Chronic Myeloid Leukemia
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 3 trial • 536 Patients • NCT02130557Trial Design
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Who is running the clinical trial?
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- I have not taken any excluded medications recently.I have been diagnosed with Ph+ acute lymphoblastic leukemia.My leukemia has only affected the lining of my brain or areas outside the bone marrow.My cancer has T315I or V299L BCR-ABL1 mutations.My magnesium and potassium levels are normal without treatment.My kidneys are working well.My leukemia is Philadelphia chromosome-positive.I do not have a long QT interval nor need medications that prolong it.I am not pregnant.I do not have severe health or mental conditions that could affect my study participation.I have had a bad reaction or no response to a previous cancer drug treatment.I am between 1 and 17 years old.My liver functions within the normal range.I have recovered from the side effects of my previous treatments.I am willing and able to follow the study's schedule and procedures.I have a history of hepatitis B, C, or HIV.I do not have any serious or uncontrolled infections.I have a heart condition.I have a serious stomach or intestine condition.My blood tests show normal white cell and platelet counts.
- Group 1: Single Agent Bosutinib
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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"
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."
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."
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."
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."
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."
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