CompletedPhase 2

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

United States, Australia, Canada106 participantsStarted 2012-04-13

Plain-language summary

The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia

Who can participate

Age range

1 Year – 17 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: * Newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukemia (ALL) * Age \>1 year and \< less than 18 years old * Induction chemotherapy ≤ 14 days according to institutional standard of care * Adequate liver, renal and cardiac function Exclusion Criteria: * Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor * Extramedullary involvement of the testicles * Active systemic bacterial, fungal or viral infection * Down syndrome

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

3-year Event-free Survival (EFS) Rate

Timeframe: From first dose to 3 years following first dose

Trial details

NCT IDNCT01460160

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-05-28

Results submitted2018-05-25

View on ClinicalTrials.gov More Leukemia, Pediatric trials

Who can participate

Age range

1 Year – 17 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.