A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chro… (NCT00777036) | Clinical Trial Compass
CompletedPhase 2
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
United States, Argentina, Australia133 participantsStarted 2009-03-20
Plain-language summary
The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated
Who can participate
Age range
1 Day – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
* CP-CML who prove resistant or intolerant to imatinib (Cohort 1)
* Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2)
* Newly diagnosed, treatment naive CP-CML (Cohort 3)
* Lansky or Karnofsky scale \>50
* Life expectancy ≥12 weeks
* Adequate hepatic and renal function
* Written informed consent
* Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation
* 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 dasatinib tablets outside of this protocol may be invited to participate in this PK substudy
* Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2
* Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible
* Target Population for the PK substudy subjects must meet relevant inclusion criteria
Exclusion Criteria:
* Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
* Symptomatic CNS involvement (other than signs and symptoms ca…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Major Cytogenetic Response (MCyR) Rate
Timeframe: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
2
Complete Hematologic Response (CHR) Rate
Timeframe: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
3
Complete Cytogenetic Response (CCyR) Rate
Timeframe: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)