Overview
Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia
Status:
Active, not recruiting
Active, not recruiting
Trial end date:
2021-05-28
2021-05-28
Target enrollment:
0
0
Participant gender:
All
All
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 leukemiaPhase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers SquibbCollaborators:
Children's Oncology Group
EsPhALL
EsPhALL - European Intergroup Study on Post Induction Treatment of Philadelphia Positive Acute Lymphoblastic Leukaemia with ImatinibTreatments:
Dasatinib
Criteria
For more information regarding BMS clinical trial participation, please visitwww.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