CompletedPhase 2

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

United States106 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 range1 Year – 17 Years

SexALL

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

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