Overview

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

Status:
Active, not recruiting
Trial end date:
2021-05-28
Target enrollment:
0
Participant gender:
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 leukemia
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Collaborators:
Children's Oncology Group
EsPhALL
EsPhALL - European Intergroup Study on Post Induction Treatment of Philadelphia Positive Acute Lymphoblastic Leukaemia with Imatinib
Treatments:
Dasatinib
Criteria
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