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Dasatinib for Pediatric Leukemia
Study Summary
This trial will test the safety and effectiveness of dasatinib in children and adolescents with leukemia who either have not responded to or cannot tolerate imatinib.
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 2022 Phase 2 trial • 54 Patients • NCT03023046Trial Design
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Who is running the clinical trial?
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- I am not using proton pump inhibitors, H2 antagonists, or CYP3A4 modifiers.I have CML and cannot tolerate or didn't respond to imatinib.I can do most activities but need help with some.My liver and kidneys are working well.I have chronic phase CML and am currently taking dasatinib daily as part of this study.I have previously been treated with imatinib or another TKI therapy.My cancer is located outside the bone marrow.I have been treated with Dasatinib before.I have leukemia and didn't respond well or relapsed after imatinib treatment.I have just been diagnosed with chronic myeloid leukemia and haven't started treatment.I have CP-CML and am taking a dasatinib dose of at least 60 mg/m2 or 72 mg/m2.I am eligible for a treatment that could potentially cure my condition, including a stem cell transplant.I have symptoms from my brain or spinal cord involvement, not from leptomeningeal disease.
- Group 1: Cohort 2: Ph+ALL or AP- or BP-CML
- Group 2: Cohort 3: Newly diagnosed, treatment naïve CP-CML
- Group 3: Cohort 1: Imatinib-resistant/intolerant CP-CML
- 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
Does this experiment only test on subjects who are older than 45?
"Children as young as one day old may participate in this trial, provided they meet the other requirements listed in the inclusion criteria. There are 460 clinical trials currently seeking participants who are under 18 years old and 1259 studies recruiting people that are over 65."
How many different locations are conducting this trial?
"Currently, 47 clinical trial locations are active and recruiting patients. These include Local Institution - 0004 in Atlanta, Children's Healthcare of Atlanta - Egleston Hospital in New york, Local Institution - 0061 in Toronto, as well as 44 other sites."
How many willing test subjects are required for this clinical trial?
"This particular trial is no longer enrolling patients. It was initially posted on March 20th, 2009 and last updated on November 7th, 2022. However, if you are interested in participating in other trials, there are currently 1507 trials related to leukemia and 66 for Dasatinib that are actively recruiting participants."
Has the FDA cleared Dasatinib for public use?
"Dasatinib safety was given a score of 2 by our analysts at Power. This is because, while there is some evidence suggesting the medication is safe, there is no data attesting to its efficacy."
What are the goals of this experiment?
"The purpose of this study is to track Major Cytogenetic Response (MCyR) Rate over the course of treatment and follow up. Additionally, researchers will be paying attention to Time to MCyR, Complete Cytogenetic Response (CCyR) Rate, and Complete Hematologic Response (CHR) rate in order to better understand the efficacy of the medication."
Who would be a good candidate to sign up for this research project?
"This trial is looking for 130 participants aged 1 day to 18 years old who have leukemia. In addition to meeting the general age and health criteria, potential patients must also match the following specific profile: -Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasasinib tablets outside of this protocol may be invited to participate in this PK substudy, -Target Population for the PK substudy must obtain written informed"
Are they looking for more test subjects at this time?
"The study you are inquiring about is not enrolling new patients at this time, as reflected on clinicaltrials.gov. This research was first posted on March 20th, 2009 and last updated on November 7th, 2020. There are 1573 other trials that may be of interest to you which are actively recruiting right now."
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